Nivolumab History and Updates

250 events · 2005 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: .

154
FDA Approvals
3
Label Revisions
5,351
Trial Milestones
10
Pivotal Publications
Nivolumab — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications20062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028202920302031203220332034203520362037203820392040Trial: NCT07176975 2027-08-03 → 2029-01-15 (primary completion)Trial: NCT07644312 2027-03-01 → 2033-03-01 (primary completion)Trial: NCT07369791 2026-12-31 → 2035-12-31 (primary completion)Trial: NCT07572123 2026-12-04 → 2029-03-31 (primary completion)Trial: NCT07459543 2026-11-15 → 2029-05-26 (primary completion)Trial: NCT07631325 2026-10-31 → 2028-07-31 (primary completion)Trial: NCT07689175 2026-10-31 → 2031-10-31 (primary completion)Trial: NCT07770100 2026-10-01 → 2040-02-28 (primary completion)Trial: NCT07551583 2026-10-01 → 2030-12-31 (primary completion)Trial: NCT07430202 2026-09-30 → 2030-09-30 (primary completion)Trial: NCT07741565 2026-09-30 → 2031-09-30 (primary completion)Trial: NCT07679841 2026-09-30 → 2029-09-30 (primary completion)Trial: NCT07420439 2026-09-15 → 2028-08-15 (primary completion)Trial: NCT07576725 2026-09-01 → 2029-08-31 (primary completion)Trial: NCT07541170 2026-09-01 → 2032-01-31 (primary completion)Trial: NCT06639607 2026-08-31 → 2031-08-31 (primary completion)Trial: NCT07281924 2026-08-31 → 2030-12-31 (primary completion)Trial: NCT07476326 2026-08-31 → 2027-08-16 (primary completion)Trial: NCT07694986 2026-08-31 → 2029-08-31 (primary completion)Trial: NCT07444619 2026-08-31 → 2031-12-31 (primary completion)Trial: NCT06319196 2026-08-27 → 2027-02-15 (primary completion)Trial: NCT07664176 2026-08-24 → 2030-12-31 (primary completion)Trial: NCT07700979 2026-08-20 → 2029-08-18 (primary completion)Trial: NCT07740941 2026-08-05 → 2029-03-31 (primary completion)Trial: NCT06365619 2026-07-31 → 2027-08-31 (primary completion)Trial: NCT07355205 2026-07-31 → 2032-07-31 (primary completion)Trial: NCT07546812 2026-07-31 → 2030-01-31 (primary completion)Trial: NCT07460765 2026-07-31 → 2030-04-30 (primary completion)Trial: NCT07645118 2026-07-31 → 2028-12-31 (primary completion)Trial: NCT07492680 2026-07-17 → 2032-05-20 (primary completion)Trial: NCT07518043 2026-06-30 → 2027-08-12 (primary completion)Trial: NCT07383441 2026-06-10 → 2033-01-31 (primary completion)Trial: NCT07494435 2026-06-01 → 2028-06-01 (primary completion)Trial: NCT07529873 2026-05-31 → 2030-04-30 (primary completion)Trial: NCT07514767 2026-05-01 → 2028-09-30 (primary completion)Trial: NCT07501117 2026-05-01 → 2029-06-01 (primary completion)Trial: NCT07510334 2026-05-01 → 2033-08-01 (primary completion)Trial: NCT07338981 2026-04-30 → 2030-12-31 (primary completion)Trial: NCT07527858 2026-04-30 → 2028-12-31 (primary completion)Trial: NCT07188896 2026-04-29 → 2029-11-30 (primary completion)Trial: NCT07392892 2026-04-28 → 2031-07-22 (primary completion)Trial: NCT07319195 2026-04-27 → 2028-04-30 (primary completion)Trial: NCT07504796 2026-04-13 → 2029-05-31 (primary completion)Trial: NCT07532902 2026-04-07 → 2029-04-30 (primary completion)Trial: NCT07128680 2026-04-01 → 2028-08-25 (primary completion)Trial: NCT07075120 2026-04-01 → 2027-08-01 (primary completion)Trial: NCT07187869 2026-03-31 → 2027-04-07 (primary completion)Trial: NCT07210632 2026-03-30 → 2030-03-30 (primary completion)Trial: NCT07563738 2026-03-27 → 2029-09-30 (primary completion)Trial: NCT07401875 2026-03-24 → 2027-11-30 (primary completion)Trial: NCT07405164 2026-03-23 → 2034-01-14 (primary completion)Trial: NCT07219459 2026-03-19 → 2029-09-30 (primary completion)Trial: NCT07221149 2026-03-13 → 2030-11-08 (primary completion)Trial: NCT06863311 2026-03-13 → 2027-12-31 (primary completion)Trial: NCT07485166 2026-03-12 → 2026-09-12 (primary completion)Trial: NCT07404332 2026-02-28 → 2028-02-28 (primary completion)Trial: NCT07432295 2026-02-28 → 2030-03-31 (primary completion)Trial: NCT07394062 2026-02-28 → 2027-08-31 (primary completion)Trial: NCT07166406 2026-02-26 → 2029-03-10 (primary completion)Trial: NCT06999980 2026-02-09 → 2028-03-31 (primary completion)Trial: NCT07398937 2026-02-05 → 2027-12-31 (primary completion)Trial: NCT07325136 2026-02-03 → 2029-04-23 (primary completion)Trial: NCT07431281 2026-02-03 → 2029-08-16 (primary completion)Trial: NCT07328087 2026-02-02 → 2030-12-02 (primary completion)Trial: NCT07403877 2026-02-01 → 2031-12-31 (primary completion)Trial: NCT07216833 2026-01-31 → 2027-07-31 (primary completion)Trial: NCT07276373 2026-01-16 → 2026-09-30 (primary completion)Trial: NCT07195695 2026-01-16 → 2032-02-26 (primary completion)Trial: NCT07230613 2026-01-12 → 2027-12-31 (primary completion)Trial: NCT06968988 2026-01-05 → 2029-02-12 (primary completion)Trial: NCT07221734 2025-12-29 → 2027-04-30 (primary completion)Trial: NCT06963905 2025-12-29 → 2030-12-31 (primary completion)Trial: NCT07017816 2025-12-16 → 2028-05-01 (primary completion)Trial: NCT07196384 2025-12-15 → 2026-10-30 (primary completion)Trial: NCT07226856 2025-12-12 → 2028-12-01 (primary completion)Trial: NCT06908993 2025-12-09 → 2028-03-15 (primary completion)Trial: NCT06346197 2025-12-08 → 2028-05-15 (primary completion)Trial: NCT07526961 2025-12-01 → 2026-01-20 (primary completion)Trial: NCT07233668 2025-12-01 → 2028-10-01 (primary completion)Trial: NCT06816927 2025-11-28 → 2029-06-01 (primary completion)Trial: NCT07334119 2025-11-25 → 2027-01-31 (primary completion)Trial: NCT07176650 2025-11-25 → 2026-12-31 (primary completion)Trial: NCT07223411 2025-11-19 → 2028-11-01 (primary completion)Trial: NCT06948448 2025-11-18 → 2028-02-15 (primary completion)Trial: NCT07223424 2025-11-04 → 2030-11-30 (primary completion)Trial: NCT06794229 2025-10-30 → 2028-06-06 (primary completion)Trial: NCT07155317 2025-10-29 → 2026-12-31 (primary completion)Trial: NCT05717140 2025-10-28 → 2026-01-28 (primary completion)Trial: NCT07246863 2025-10-07 → 2029-10-01 (primary completion)Trial: NCT07174453 2025-10-07 → 2027-10-01 (primary completion)Trial: NCT07028125 2025-10-01 → 2028-10-31 (primary completion)Trial: NCT07152678 2025-09-30 → 2027-09-30 (primary completion)Trial: NCT06946797 2025-09-19 → 2027-02-05 (primary completion)Trial: NCT06410534 2025-09-09 → 2025-09-09 (primary completion)Trial: NCT06941857 2025-09-04 → 2028-12-31 (primary completion)Trial: NCT07147101 2025-09-01 → 2028-09-01 (primary completion)Trial: NCT06624475 2025-08-21 → 2028-05-31 (primary completion)Trial: NCT06866262 2025-08-15 → 2031-08-01 (primary completion)Trial: NCT07011550 2025-08-15 → 2028-07-01 (primary completion)Trial: NCT07013565 2025-08-07 → 2029-07-01 (primary completion)Trial: NCT06712927 2025-08-06 → 2026-11-30 (primary completion)Trial: NCT06624644 2025-08-06 → 2029-02-28 (primary completion)Trial: NCT07092670 2025-08-04 → 2028-08-01 (primary completion)Trial: NCT07209059 2025-07-29 → 2027-12-31 (primary completion)Trial: NCT07000149 2025-07-28 → 2030-02-21 (primary completion)Trial: NCT07031765 2025-07-25 → 2030-12-31 (primary completion)Trial: NCT07061379 2025-07-24 → 2027-06-30 (primary completion)Trial: NCT06794775 2025-07-10 → 2032-04-15 (primary completion)Trial: NCT06767956 2025-06-30 → 2027-04-30 (primary completion)Trial: NCT05733689 2025-06-27 → 2027-06-30 (primary completion)Trial: NCT06896110 2025-06-05 → 2027-03-31 (primary completion)Trial: NCT07542262 2025-06-03 → 2028-03-30 (primary completion)Trial: NCT06163820 2025-05-31 → 2026-01-30 (primary completion)Trial: NCT06364917 2025-05-30 → 2027-04-27 (primary completion)Trial: NCT07141563 2025-05-26 → 2025-11-18 (primary completion)Trial: NCT06889493 2025-05-19 → 2030-06-01 (primary completion)Trial: NCT07050043 2025-05-19 → 2030-12-31 (primary completion)Trial: NCT06934057 2025-05-16 → 2028-04-30 (primary completion)Trial: NCT06823479 2025-05-14 → 2029-02-28 (primary completion)Trial: NCT07091695 2025-05-11 → 2025-11-06 (primary completion)Trial: NCT06683755 2025-05-01 → 2030-08-16 (primary completion)Trial: NCT06983210 2025-05-01 → 2027-03-01 (primary completion)Trial: NCT06800339 2025-04-22 → 2028-03-31 (primary completion)Trial: NCT06984146 2025-04-15 → 2028-01-31 (primary completion)Trial: NCT07100704 2025-04-15 → 2028-04-14 (primary completion)Trial: NCT06731270 2025-04-09 → 2027-01-01 (primary completion)Trial: NCT06712875 2025-04-01 → 2028-12-31 (primary completion)Trial: NCT06880549 2025-03-25 → 2029-01-10 (primary completion)Trial: NCT06764771 2025-03-25 → 2027-10-15 (primary completion)Trial: NCT06245356 2025-03-21 → 2026-10-22 (primary completion)Trial: NCT06708949 2025-03-20 → 2026-12-15 (primary completion)Trial: NCT06534190 2025-03-11 → 2028-11-30 (primary completion)Trial: NCT06745076 2025-03-06 → 2032-01-03 (primary completion)Trial: NCT06901817 2025-03-01 → 2027-11-30 (primary completion)Trial: NCT06523621 2025-02-28 → 2026-03-21 (primary completion)Trial: NCT06561087 2025-02-27 → 2027-05-30 (primary completion)Trial: NCT07084610 2025-02-25 → 2027-07-31 (primary completion)Trial: NCT06646276 2025-02-25 → 2028-04-06 (primary completion)Trial: NCT06697197 2025-02-17 → 2029-01-04 (primary completion)Trial: NCT06926790 2025-02-17 → 2030-03-31 (primary completion)Trial: NCT06618287 2025-02-04 → 2031-02-26 (primary completion)Trial: NCT06743126 2025-01-14 → 2028-01-31 (primary completion)Trial: NCT06692491 2025-01-01 → 2027-12-31 (primary completion)Trial: NCT06587451 2024-12-19 → 2026-01-23 (primary completion)Trial: NCT06581406 2024-12-17 → 2030-01-31 (primary completion)Trial: NCT06715241 2024-12-11 → 2030-12-31 (primary completion)Trial: NCT06632327 2024-12-11 → 2029-04-30 (primary completion)Trial: NCT06504615 2024-12-10 → 2028-08-31 (primary completion)Trial: NCT06534983 2024-12-09 → 2027-11-10 (primary completion)Trial: NCT06519682 2024-12-06 → 2026-12-31 (primary completion)Trial: NCT06499298 2024-12-03 → 2025-04-16 (primary completion)Trial: NCT05457959 2024-12-01 → 2029-12-01 (primary completion)Trial: NCT07079644 2024-11-29 → 2025-03-31 (primary completion)Trial: NCT05647265 2024-11-27 → 2026-12-15 (primary completion)Trial: NCT07215962 2024-11-22 → 2025-07-01 (primary completion)Trial: NCT06682728 2024-11-15 → 2026-12-01 (primary completion)Trial: NCT06325683 2024-11-08 → 2028-07-15 (primary completion)Trial: NCT05629546 2024-11-06 → 2029-02-28 (primary completion)Trial: NCT07024862 2024-10-24 → 2025-06-30 (primary completion)Trial: NCT06490536 2024-10-22 → 2026-03-01 (primary completion)Trial: NCT06544655 2024-10-10 → 2027-10-14 (primary completion)Trial: NCT06561386 2024-10-07 → 2030-07-30 (primary completion)Trial: NCT06246916 2024-09-09 → 2027-03-22 (primary completion)Trial: NCT06735781 2024-09-05 → 2024-10-01 (primary completion)Trial: NCT06572722 2024-09-01 → 2026-09-01 (primary completion)Trial: NCT06871007 2024-09-01 → 2029-09-01 (primary completion)Trial: NCT06362369 2024-08-23 → 2027-12-31 (primary completion)Trial: NCT06284564 2024-08-07 → 2026-10-01 (primary completion)Trial: NCT06532149 2024-08-05 → 2026-09-05 (primary completion)Trial: NCT05898828 2024-08-02 → 2024-08-02 (primary completion)Trial: NCT06495125 2024-07-31 → 2029-03-17 (primary completion)Trial: NCT06421311 2024-07-30 → 2025-04-04 (primary completion)Trial: NCT05896839 2024-07-24 → 2027-01-31 (primary completion)Trial: NCT06638931 2024-07-16 → 2026-07-31 (primary completion)Trial: NCT06029270 2024-07-15 → 2029-04-30 (primary completion)Trial: NCT06466798 2024-07-15 → 2027-07-01 (primary completion)Trial: NCT06264180 2024-07-11 → 2030-09-30 (primary completion)Trial: NCT06208657 2024-07-10 → 2030-12-31 (primary completion)Trial: NCT06554613 2024-07-02 → 2026-12-01 (primary completion)Trial: NCT06302426 2024-07-01 → 2026-10-30 (primary completion)Trial: NCT05153304 2024-06-30 → 2026-06-30 (primary completion)Trial: NCT06064097 2024-06-25 → 2027-03-31 (primary completion)Trial: NCT06203600 2024-06-24 → 2027-10-31 (primary completion)Trial: NCT06377111 2024-06-24 → 2027-08-31 (primary completion)Trial: NCT06288191 2024-06-21 → 2026-09-30 (primary completion)Trial: NCT06399419 2024-06-19 → 2026-10-19 (primary completion)Trial: NCT06112314 2024-06-05 → 2027-10-16 (primary completion)Trial: NCT06771674 2024-06-05 → 2025-02-28 (primary completion)Trial: NCT06274437 2024-06-02 → 2027-09-30 (primary completion)Trial: NCT06357858 2024-06-01 → 2025-02-28 (primary completion)Trial: NCT06295159 2024-05-17 → 2028-11-30 (primary completion)Trial: NCT06265285 2024-04-30 → 2026-12-31 (primary completion)Trial: NCT06253611 2024-04-16 → 2027-09-30 (primary completion)Trial: NCT06364631 2024-04-12 → 2032-05-05 (primary completion)Trial: NCT06304597 2024-04-01 → 2025-03-01 (primary completion)Trial: NCT07436390 2024-03-31 → 2024-03-31 (primary completion)Trial: NCT06247540 2024-03-29 → 2029-12-29 (primary completion)Trial: NCT07523763 2024-03-22 → 2025-12-31 (primary completion)Trial: NCT06640530 2024-03-21 → 2025-12-31 (primary completion)Trial: NCT06097975 2024-03-15 → 2025-06-01 (primary completion)FDA approval — 2005-12-02 FDA approved Hylenex Recombinant (hyaluronidase) (BLA 021859) Sponsor: HALOZYME THERAP. Class: Type 1 - New Molecular Entity.FDA approval (supplemental) — 2006-06-09 FDA approved supplemental application for Hylenex Recombinant (hyaluronidase) — Labeling (BLA 021859 S-2) Sponsor: HALOZYME THERAP. Class: Labeling.FDA approval (supplemental) — 2008-10-01 FDA approved supplemental application for Hylenex Recombinant (hyaluronidase) — Labeling (BLA 021859 S-5) Sponsor: HALOZYME THERAP. Class: Labeling.FDA approval (supplemental) — 2009-12-11 FDA approved supplemental application for Hylenex Recombinant (hyaluronidase) — Labeling (BLA 021859 S-6) Sponsor: HALOZYME THERAP. Class: Labeling.FDA approval (supplemental) — 2012-03-01 FDA approved supplemental application for Hylenex Recombinant (hyaluronidase) — Labeling (BLA 021859 S-9) Sponsor: HALOZYME THERAP. Class: Labeling.FDA approval (supplemental) — 2012-03-20 FDA approved supplemental application for Hylenex Recombinant (hyaluronidase) — Labeling (BLA 021859 S-15) Sponsor: HALOZYME THERAP. Class: Labeling.FDA approval (supplemental) — 2013-07-23 FDA approved supplemental application for Hylenex Recombinant (hyaluronidase) — Manufacturing (CMC) (BLA 021859 S-18) Sponsor: HALOZYME THERAP. Class: Manufacturing (CMC).FDA approval (supplemental) — 2014-05-06 FDA approved supplemental application for Hylenex Recombinant (hyaluronidase) — Manufacturing (CMC) (BLA 021859 S-20) Sponsor: HALOZYME THERAP. Class: Manufacturing (CMC).FDA approval (supplemental) — 2014-10-16 FDA approved supplemental application for Hylenex Recombinant (hyaluronidase) — Manufacturing (CMC) (BLA 021859 S-19) Sponsor: HALOZYME THERAP. Class: Manufacturing (CMC).FDA approval — 2014-12-22 FDA approved Opdivo (nivolumab) (BLA 125554) Sponsor: BRISTOL MYERS SQUIBB. Class: Type 1 - New Molecular Entity.FDA approval (supplemental) — 2015-04-14 FDA approved supplemental application for Opdivo (nivolumab) — Labeling (BLA 125554 S-4) Sponsor: BRISTOL MYERS SQUIBB. Class: Labeling.FDA approval (supplemental) — 2015-04-14 FDA approved supplemental application for Opdivo (nivolumab) — Labeling (BLA 125554 S-3) Sponsor: BRISTOL MYERS SQUIBB. Class: Labeling.FDA approval (supplemental) — 2015-04-17 FDA approved supplemental application for Hylenex Recombinant (hyaluronidase) — Manufacturing (CMC) (BLA 021859 S-21) Sponsor: HALOZYME THERAP. Class: Manufacturing (CMC).FDA approval (supplemental) — 2015-07-27 FDA approved supplemental application for Hylenex Recombinant (hyaluronidase) — Manufacturing (CMC) (BLA 021859 S-22) Sponsor: HALOZYME THERAP. Class: Manufacturing (CMC).FDA approval (supplemental) — 2015-09-30 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-2) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2015-10-09 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-5) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2015-11-23 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-12) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2015-11-23 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-1) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2016-01-21 FDA approved supplemental application for Hylenex Recombinant (hyaluronidase) — Labeling (BLA 021859 S-23) Sponsor: HALOZYME THERAP. Class: Labeling.FDA approval (supplemental) — 2016-01-23 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-7) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2016-05-17 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-19) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2016-06-21 FDA approved supplemental application for Hylenex Recombinant (hyaluronidase) — Manufacturing (CMC) (BLA 021859 S-25) Sponsor: HALOZYME THERAP. Class: Manufacturing (CMC).FDA approval (supplemental) — 2016-07-28 FDA approved supplemental application for Hylenex Recombinant (hyaluronidase) — Manufacturing (CMC) (BLA 021859 S-24) Sponsor: HALOZYME THERAP. Class: Manufacturing (CMC).FDA approval (supplemental) — 2016-09-13 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-17) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2016-09-13 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-18) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2016-10-04 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-16) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2016-11-10 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-22) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2017-02-02 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-24) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2017-04-25 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-31) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2017-06-22 FDA approved supplemental application for Rituxan Hycela (rituximab and hyaluronidase) — Type 5 - New Formulation or New Manufacturer (BLA 761064 S-1) Sponsor: GENENTECH INC. Class: Type 5 - New Formulation or New Manufacturer.FDA approval — 2017-06-22 FDA approved Rituxan Hycela (rituximab and hyaluronidase) (BLA 761064) Sponsor: GENENTECH INC. Class: Type 5 - New Formulation or New Manufacturer.FDA approval (supplemental) — 2017-07-31 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-34) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2017-09-06 FDA approved supplemental application for Opdivo (nivolumab) — Labeling (BLA 125554 S-40) Sponsor: BRISTOL MYERS SQUIBB. Class: Labeling.FDA approval (supplemental) — 2017-09-22 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-41) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2017-12-20 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-55) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2018-01-09 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-36) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2018-01-09 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-35) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2018-01-09 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-37) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2018-01-09 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-39) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2018-01-09 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-38) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2018-02-13 FDA approved supplemental application for Opdivo (nivolumab) — Labeling (BLA 125554 S-56) Sponsor: BRISTOL MYERS SQUIBB. Class: Labeling.FDA approval (supplemental) — 2018-02-15 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-45) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2018-02-15 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-44) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2018-03-05 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-61) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2018-03-05 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-49) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2018-03-05 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-48) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2018-03-05 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-62) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2018-03-05 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-66) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2018-03-05 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-52) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2018-03-05 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-51) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2018-03-05 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-65) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2018-03-05 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-64) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2018-03-05 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-50) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2018-04-16 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-58) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2018-07-10 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-63) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2018-08-16 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-67) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2018-11-15 FDA approved supplemental application for Opdivo (nivolumab) — Labeling (BLA 125554 S-69) Sponsor: BRISTOL MYERS SQUIBB. Class: Labeling.FDA approval (supplemental) — 2019-02-01 FDA approved supplemental application for Opdivo (nivolumab) — Labeling (BLA 125554 S-72) Sponsor: BRISTOL MYERS SQUIBB. Class: Labeling.FDA approval — 2019-02-28 FDA approved Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) (BLA 761106) Sponsor: GENENTECH INC. Class: Type 5 - New Formulation or New Manufacturer.FDA approval (supplemental) — 2019-03-07 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-42) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2019-04-18 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-70) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2019-05-02 FDA approved supplemental application for Opdivo (nivolumab) — Labeling (BLA 125554 S-73) Sponsor: BRISTOL MYERS SQUIBB. Class: Labeling.FDA approval (supplemental) — 2019-09-18 FDA approved supplemental application for Opdivo (nivolumab) — Labeling (BLA 125554 S-75) Sponsor: BRISTOL MYERS SQUIBB. Class: Labeling.FDA approval (supplemental) — 2019-12-19 FDA approved supplemental application for Rituxan Hycela (rituximab and hyaluronidase) — Labeling (BLA 761064 S-9) Sponsor: GENENTECH INC. Class: Labeling.FDA approval (supplemental) — 2020-03-10 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-78) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval — 2020-05-01 FDA approved Darzalex Faspro (daratumumab and hyaluronidase-fihj (human recombinant)) (BLA 761145) Sponsor: JANSSEN BIOTECH. Class: Type 3 - New Dosage Form and Type 4 - New Combination.FDA approval (supplemental) — 2020-05-05 FDA approved supplemental application for Rituxan Hycela (rituximab and hyaluronidase) — Labeling (BLA 761064 S-10) Sponsor: GENENTECH INC. Class: Labeling.FDA approval (supplemental) — 2020-05-05 FDA approved supplemental application for Rituxan Hycela (rituximab and hyaluronidase) — Labeling (BLA 761064 S-8) Sponsor: GENENTECH INC. Class: Labeling.FDA approval (supplemental) — 2020-05-15 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-80) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2020-05-26 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-82) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2020-06-10 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-81) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2020-06-23 FDA approved supplemental application for Opdivo (nivolumab) — Labeling (BLA 125554 S-83) Sponsor: BRISTOL MYERS SQUIBB. Class: Labeling.FDA approval — 2020-06-29 FDA approved Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf) (BLA 761170) Sponsor: GENENTECH INC. Class: Type 4 - New Combination.FDA approval (supplemental) — 2020-09-18 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-84) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2020-09-18 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-85) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2020-09-25 FDA approved supplemental application for Opdivo (nivolumab) — Labeling (BLA 125554 S-86) Sponsor: BRISTOL MYERS SQUIBB. Class: Labeling.FDA approval (supplemental) — 2020-10-02 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-89) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2020-11-10 FDA approved supplemental application for Opdivo (nivolumab) — Labeling (BLA 125554 S-71) Sponsor: BRISTOL MYERS SQUIBB. Class: Labeling.FDA approval (supplemental) — 2020-12-29 FDA approved supplemental application for Opdivo (nivolumab) — Labeling (BLA 125554 S-95) Sponsor: BRISTOL MYERS SQUIBB. Class: Labeling.FDA approval (supplemental) — 2021-01-11 FDA approved supplemental application for Darzalex Faspro (daratumumab and hyaluronidase-fihj (human recombinant)) — Efficacy (BLA 761145 S-1) Sponsor: JANSSEN BIOTECH. Class: Efficacy.FDA approval (supplemental) — 2021-01-15 FDA approved supplemental application for Darzalex Faspro (daratumumab and hyaluronidase-fihj (human recombinant)) — Efficacy (BLA 761145 S-2) Sponsor: JANSSEN BIOTECH. Class: Efficacy.FDA approval (supplemental) — 2021-01-22 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-90) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2021-02-08 FDA approved supplemental application for Darzalex Faspro (daratumumab and hyaluronidase-fihj (human recombinant)) — Labeling (BLA 761145 S-8) Sponsor: JANSSEN BIOTECH. Class: Labeling.FDA approval (supplemental) — 2021-03-12 FDA approved supplemental application for Darzalex Faspro (daratumumab and hyaluronidase-fihj (human recombinant)) — Labeling (BLA 761145 S-5) Sponsor: JANSSEN BIOTECH. Class: Labeling.FDA approval (supplemental) — 2021-03-30 FDA approved supplemental application for Opdivo (nivolumab) — Labeling (BLA 125554 S-98) Sponsor: BRISTOL MYERS SQUIBB. Class: Labeling.FDA approval (supplemental) — 2021-04-16 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-91) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2021-05-20 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-92) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2021-06-10 FDA approved supplemental application for Rituxan Hycela (rituximab and hyaluronidase) — Labeling (BLA 761064 S-13) Sponsor: GENENTECH INC. Class: Labeling.FDA approval (supplemental) — 2021-07-09 FDA approved supplemental application for Darzalex Faspro (daratumumab and hyaluronidase-fihj (human recombinant)) — Efficacy (BLA 761145 S-7) Sponsor: JANSSEN BIOTECH. Class: Efficacy.FDA approval (supplemental) — 2021-07-15 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-99) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2021-07-23 FDA approved supplemental application for Opdivo (nivolumab) — Labeling (BLA 125554 S-107) Sponsor: BRISTOL MYERS SQUIBB. Class: Labeling.FDA approval (supplemental) — 2021-08-19 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-97) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2021-11-30 FDA approved supplemental application for Darzalex Faspro (daratumumab and hyaluronidase-fihj (human recombinant)) — Efficacy (BLA 761145 S-9) Sponsor: JANSSEN BIOTECH. Class: Efficacy.FDA approval (supplemental) — 2022-01-21 FDA approved supplemental application for Darzalex Faspro (daratumumab and hyaluronidase-fihj (human recombinant)) — Labeling (BLA 761145 S-12) Sponsor: JANSSEN BIOTECH. Class: Labeling.FDA approval (supplemental) — 2022-02-25 FDA approved supplemental application for Opdivo (nivolumab) — Labeling (BLA 125554 S-109) Sponsor: BRISTOL MYERS SQUIBB. Class: Labeling.FDA approval (supplemental) — 2022-03-04 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-112) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval — 2022-03-18 FDA approved Opdualag (nivolumab and relatlimab-rmbw) (BLA 761234) Sponsor: BRISTOL MYERS SQUIBB. Class: Type 1 - New Molecular Entity.FDA approval (supplemental) — 2022-05-11 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-108) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2022-05-27 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-105) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2022-05-27 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-106) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2022-07-14 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-114) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2022-11-02 FDA approved supplemental application for Darzalex Faspro (daratumumab and hyaluronidase-fihj (human recombinant)) — Labeling (BLA 761145 S-18) Sponsor: JANSSEN BIOTECH. Class: Labeling.FDA approval (supplemental) — 2023-02-15 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-117) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2023-02-15 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-118) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2023-02-15 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-119) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval — 2023-06-20 FDA approved Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase (human recombinant)) (BLA 761304) Sponsor: ARGENX BV.FDA approval (supplemental) — 2023-10-13 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-121) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2023-12-12 FDA approved supplemental application for Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase (human recombinant)) — Labeling (BLA 761304 S-2) Sponsor: ARGENX BV. Class: Labeling.FDA approval (supplemental) — 2024-01-12 FDA approved supplemental application for Hylenex Recombinant (hyaluronidase) — Labeling (BLA 021859 S-31) Sponsor: HALOZYME THERAP. Class: Labeling.FDA approval (supplemental) — 2024-01-26 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-122) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2024-03-06 FDA approved supplemental application for Opdivo (nivolumab) — Labeling (BLA 125554 S-128) Sponsor: BRISTOL MYERS SQUIBB. Class: Labeling.FDA approval (supplemental) — 2024-03-06 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-125) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2024-03-06 FDA approved supplemental application for Opdualag (nivolumab and relatlimab-rmbw) — Labeling (BLA 761234 S-6) Sponsor: BRISTOL MYERS SQUIBB. Class: Labeling.FDA approval (supplemental) — 2024-06-18 FDA approved supplemental application for Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) — Efficacy (BLA 761106 S-10) Sponsor: GENENTECH INC. Class: Efficacy.FDA approval (supplemental) — 2024-06-21 FDA approved supplemental application for Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase (human recombinant)) — Efficacy (BLA 761304 S-5) Sponsor: ARGENX BV. Class: Efficacy.FDA approval (supplemental) — 2024-06-21 FDA approved supplemental application for Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase (human recombinant)) — Labeling (BLA 761304 S-6) Sponsor: ARGENX BV. Class: Labeling.FDA approval (supplemental) — 2024-07-30 FDA approved supplemental application for Darzalex Faspro (daratumumab and hyaluronidase-fihj (human recombinant)) — Efficacy (BLA 761145 S-25) Sponsor: JANSSEN BIOTECH. Class: Efficacy.FDA approval (supplemental) — 2024-08-08 FDA approved supplemental application for Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase (human recombinant)) — Efficacy (BLA 761304 S-3) Sponsor: ARGENX BV. Class: Efficacy.FDA approval — 2024-09-12 FDA approved Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) (BLA 761347) Sponsor: GENENTECH INC. Class: Type 3 - New Dosage Form.FDA approval — 2024-09-13 FDA approved Ocrevus Zunovo (ocrelizumab and hyaluronidase) (BLA 761371) Sponsor: GENENTECH INC. Class: Type 3 - New Dosage Form.FDA approval (supplemental) — 2024-10-03 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-127) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2024-11-22 FDA approved supplemental application for Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf) — Efficacy (BLA 761170 S-7) Sponsor: GENENTECH INC. Class: Efficacy.FDA approval — 2024-12-27 FDA approved Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) (BLA 761381) Sponsor: BRISTOL-MYERS SQUIBB. Class: Type 3 - New Dosage Form.FDA approval (supplemental) — 2025-04-08 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-132) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2025-04-10 FDA approved supplemental application for Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase (human recombinant)) — Efficacy (BLA 761304 S-8) Sponsor: ARGENX BV. Class: Efficacy.FDA approval (supplemental) — 2025-04-11 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-129) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2025-05-23 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-133) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2025-05-23 FDA approved supplemental application for Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) — Labeling (BLA 761381 S-8) Sponsor: BRISTOL-MYERS SQUIBB. Class: Labeling.FDA approval (supplemental) — 2025-07-01 FDA approved supplemental application for Opdivo (nivolumab) — Labeling (BLA 125554 S-131) Sponsor: BRISTOL MYERS SQUIBB. Class: Labeling.FDA approval (supplemental) — 2025-08-18 FDA approved supplemental application for Ocrevus Zunovo (ocrelizumab and hyaluronidase) — Labeling (BLA 761371 S-1) Sponsor: GENENTECH INC. Class: Labeling.FDA approval (supplemental) — 2025-08-18 FDA approved supplemental application for Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) — Labeling (BLA 761347 S-2) Sponsor: GENENTECH INC. Class: Labeling.FDA approval (supplemental) — 2025-10-02 FDA approved supplemental application for Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) — Efficacy (BLA 761347 S-3) Sponsor: GENENTECH INC. Class: Efficacy.FDA approval (supplemental) — 2025-10-17 FDA approved supplemental application for Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase (human recombinant)) — Efficacy (BLA 761304 S-10) Sponsor: ARGENX BV. Class: Efficacy.FDA approval (supplemental) — 2025-10-27 FDA approved supplemental application for Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) — Efficacy (BLA 761381 S-1) Sponsor: BRISTOL-MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2025-10-27 FDA approved supplemental application for Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) — Efficacy (BLA 761381 S-2) Sponsor: BRISTOL-MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2025-11-06 FDA approved supplemental application for Darzalex Faspro (daratumumab and hyaluronidase-fihj (human recombinant)) — Efficacy (BLA 761145 S-29) Sponsor: JANSSEN BIOTECH. Class: Efficacy.FDA approval (supplemental) — 2025-11-14 FDA approved supplemental application for Darzalex Faspro (daratumumab and hyaluronidase-fihj (human recombinant)) — Labeling (BLA 761145 S-35) Sponsor: JANSSEN BIOTECH. Class: Labeling.FDA approval (supplemental) — 2025-11-17 FDA approved supplemental application for Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) — Labeling (BLA 761347 S-5) Sponsor: GENENTECH INC. Class: Labeling.FDA approval (supplemental) — 2025-11-19 FDA approved supplemental application for Darzalex Faspro (daratumumab and hyaluronidase-fihj (human recombinant)) — Efficacy (BLA 761145 S-32) Sponsor: JANSSEN BIOTECH. Class: Efficacy.FDA approval (supplemental) — 2025-11-24 FDA approved supplemental application for Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) — Efficacy (BLA 761381 S-5) Sponsor: BRISTOL-MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2025-11-24 FDA approved supplemental application for Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) — Efficacy (BLA 761347 S-4) Sponsor: GENENTECH INC. Class: Efficacy.FDA approval — 2025-12-17 FDA approved Rybrevant Faspro (amivantamab and hyaluronidase-lpuj (human recombinant)) (BLA 761433) Sponsor: JANSSEN BIOTECH. Class: Type 5 - New Formulation or New Manufacturer.FDA approval (supplemental) — 2026-01-27 FDA approved supplemental application for Darzalex Faspro (daratumumab and hyaluronidase-fihj (human recombinant)) — Efficacy (BLA 761145 S-28) Sponsor: JANSSEN BIOTECH. Class: Efficacy.FDA approval (supplemental) — 2026-02-12 FDA approved supplemental application for Darzalex Faspro (daratumumab and hyaluronidase-fihj (human recombinant)) — Labeling (BLA 761145 S-39) Sponsor: JANSSEN BIOTECH. Class: Labeling.FDA approval — 2026-02-13 FDA approved Rybrevant Faspro (amivantamab and hyaluronidase-lpuj (human recombinant)) (BLA 761484) Sponsor: JANSSEN BIOTECH. Class: Type 5 - New Formulation or New Manufacturer.FDA approval (supplemental) — 2026-02-26 FDA approved supplemental application for Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase (human recombinant)) — Labeling (BLA 761304 S-19) Sponsor: ARGENX BV. Class: Labeling.FDA approval (supplemental) — 2026-03-20 FDA approved supplemental application for Opdivo (nivolumab) — Efficacy (BLA 125554 S-135) Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.FDA approval (supplemental) — 2026-05-08 FDA approved supplemental application for Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase (human recombinant)) — Efficacy (BLA 761304 S-18) Sponsor: ARGENX BV. Class: Efficacy.FDA approval (supplemental) — 2026-05-12 FDA approved supplemental application for Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) — Labeling (BLA 761381 S-12) Sponsor: BRISTOL-MYERS SQUIBB. Class: Labeling.FDA approval (supplemental) — 2026-05-12 FDA approved supplemental application for Opdivo (nivolumab) — Labeling (BLA 125554 S-136) Sponsor: BRISTOL MYERS SQUIBB. Class: Labeling.FDA approval (supplemental) — 2026-05-12 FDA approved supplemental application for Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) — Labeling (BLA 761347 S-9) Sponsor: GENENTECH INC. Class: Labeling.FDA approval (supplemental) — 2026-05-15 FDA approved supplemental application for Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) — Efficacy (BLA 761347 S-8) Sponsor: GENENTECH INC. Class: Efficacy.FDA approval (supplemental) — 2026-05-18 FDA approved supplemental application for Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) — Labeling (BLA 761106 S-14) Sponsor: GENENTECH INC. Class: Labeling.FDA approval (supplemental) — 2026-05-18 FDA approved supplemental application for Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf) — Labeling (BLA 761170 S-16) Sponsor: GENENTECH INC. Class: Labeling.Label revision — 2026-05-21 Boxed warning present on label on Phesgo label (effective 2026-05-21) WARNING: CARDIOMYOPATHY, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY WARNING: CARDIOMYOPATHY, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY See full prescribing information for complete boxed warning. Cardiomyopathy: PHESGO administrationLabel revision — 2026-05-29 Boxed warning present on label on Herceptin Hylecta label (effective 2026-05-29) WARNING: CARDIOMYOPATHY, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY WARNING: CARDIOMYOPATHY, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY See full prescribing information for complete boxed warning. Cardiomyopathy: HERCEPTIN HYLECTA canLabel revision — 2026-08-17 Indication and usage updated on Ocrevus Zunovo label (effective 2026-08-17) 1 INDICATIONS AND USAGE OCREVUS ZUNOVO is indicated for the treatment of: Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults Recall — 2024-09-11 HYLENEX RECOMBINANT recall — Class II: cGMP Deviations: Temperature excursion Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose Vials, Rx only, Manufactured for and marketed by Halozyme, Inc., 12390 El Camino Real San Diego California 92130, Distributed by Antares Pharma, Inc., EwingRecall — 2025-10-21 OPDUALAG recall — Class II: Lack of Assurance of Sterility. Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (12mg and 4mg/mL),Single Dose Vial, RX Only, Bristol-Myers Squibb Company, Princeton, NJ 08543, NDC 0003-7125-11Results posted — 2023-02-02 Trial results posted: NCT03430791 Trial of Combination Tumor Treating Fields (TTF; Optune), Nivolumab Plus/Minus Ipilimumab for Recurrent GlioblastomaResults posted — 2023-02-06 Trial results posted: NCT02864251 A Study of Nivolumab + Chemotherapy or Nivolumab + Ipilimumab Versus Chemotherapy in Non-Small Cell Lung Cancer (NSCLC) Participants With EpResults posted — 2023-02-08 Trial results posted: NCT03468985 Nivolumab, Cabozantinib S-Malate, and Ipilimumab in Treating Patients With Recurrent Stage IV Non-small Cell Lung CancerResults posted — 2023-02-15 Trial results posted: NCT03663166 Radiation and Chemotherapy With Ipilimumab Followed by Nivolumab for Patients With Stage III Unresectable Non-Small Cell Lung Cancer (NSCLC)Results posted — 2023-02-17 Trial results posted: NCT03121534 Ibrutinib, Nivolumab and Blinatumomab in Richter TransformationResults posted — 2023-02-28 Trial results posted: NCT03251924 A Dose Escalation and Combination Immunotherapy Study to Evaluate BMS-986226 Alone or in Combination With Nivolumab or Ipilimumab in PatientResults posted — 2023-03-06 Trial results posted: NCT02598960 An Investigational Immuno-therapy Study of Experimental Medication BMS-986156, Given by Itself or in Combination With Nivolumab in Patients Results posted — 2023-03-07 Trial results posted: NCT02581631 An Investigational Immuno-therapy Safety and Effectiveness Study of Nivolumab in Combination With Brentuximab Vedotin to Treat Non-Hodgkin LResults posted — 2023-03-08 Trial results posted: NCT03435640 REVEAL Study of NKTR-262 in Combination With NKTR-214 and Nivolumab in Patients With Locally Advanced / Metastatic Solid Tumor MalignanciesResults posted — 2023-03-13 Trial results posted: NCT02983045 A Dose Escalation and Cohort Expansion Study of NKTR-214 in Combination With Nivolumab and Other Anti-Cancer Therapies in Patients With SeleResults posted — 2023-03-17 Trial results posted: NCT02771626 Study CB-839 in Combination With Nivolumab in Patients With Melanoma, Clear Cell Renal Cell Carcinoma (ccRCC) and Non-Small Cell Lung CancerResults posted — 2023-03-23 Trial results posted: NCT03057795 Nivolumab & Brentuximab Vedotin Consolidation After Autologous SCT in Patients With High-Risk Classical Hodgkin LymphomaResults posted — 2023-03-24 Trial results posted: NCT04730349 A Study of Bempegaldesleukin (BEMPEG: NKTR-214) in Combination With Nivolumab in Children, Adolescents and Young Adults With Recurrent or TrResults posted — 2023-03-27 Trial results posted: NCT02726581 An Investigational Immuno-therapy Study of Nivolumab, Pomalidomide and Dexamethasone Combinations in Patients With Multiple MyelomaResults posted — 2023-03-28 Trial results posted: NCT03785925 A Single-Arm Study of Bempegaldesleukin (NKTR-214) Plus Nivolumab in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic UResults posted — 2023-03-30 Trial results posted: NCT03406715 Combination Immunotherapy-Ipilimumab-Nivolumab-Dendritic Cell p53 Vac - Patients With Small Cell Lung Cancer (SCLC)Results posted — 2023-04-05 Trial results posted: NCT02754141 An Investigational Immuno-therapy Study of Experimental Medication BMS-986179 Given Alone and in Combination With NivolumabResults posted — 2023-04-11 Trial results posted: NCT03729245 A Study of Bempegaldesleukin (NKTR-214: BEMPEG) in Combination With Nivolumab Compared With the Investigator's Choice of a Tyrosine Kinase IResults posted — 2023-04-18 Trial results posted: NCT02426892 Nivolumab and HPV-16 Vaccination in Patients With HPV-16 Positive Incurable Solid TumorsResults posted — 2023-04-21 Trial results posted: NCT04410445 Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma iResults posted — 2023-04-24 Trial results posted: NCT03168464 Radiation and Immune Checkpoints Blockade in Metastatic NSCLC (BMS # CA209-632)Results posted — 2023-04-24 Trial results posted: NCT02985957 A Study of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer (CheckMatResults posted — 2023-04-26 Trial results posted: NCT02327078 A Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers (ECHOResults posted — 2023-05-01 Trial results posted: NCT03033576 Testing Treatment With Ipilimumab and Nivolumab Compared to Treatment With Ipilimumab Alone in Advanced MelanomaResults posted — 2023-05-18 Trial results posted: NCT03668119 A Study of Nivolumab Combined With Ipilimumab and Nivolumab Alone in Patients With Advanced or Metastatic Solid Tumors of High Tumor MutatioResults posted — 2023-05-19 Trial results posted: NCT03071406 Randomized Study of Nivolumab+Ipilimumab+/- SBRT for Metastatic Merkel Cell CarcinomaResults posted — 2023-05-26 Trial results posted: NCT03417154 Nivolumab and Oral Cyclophosphamide for R/R AML and HIgh Risk MDSResults posted — 2023-06-01 Trial results posted: NCT03519256 A Study of Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 With or Without Bacillus Calumette-Guerin (BCG) in BCG UnresponsivResults posted — 2023-06-06 Trial results posted: NCT03001882 An Exploratory Study of the Effects of Nivolumab Combined With Ipilimumab in Patients With Treatment-Naive Stage IV or Recurrent Non-Small CResults posted — 2023-06-09 Trial results posted: NCT03436862 Nivolumab Maintenance Therapy After Autologous Stem Cell Transplant in Hodgkin Lymphoma Pts at Relapse/Progression RiskResults posted — 2023-06-09 Trial results posted: NCT02935634 A Study to Test Combination Treatments in Participants With Advanced Gastric CancerResults posted — 2023-06-09 Trial results posted: NCT04166383 VB-111 in Combination With Nivolumab in People With Metastatic Colorectal Cancer (mCRC)Results posted — 2023-06-12 Trial results posted: NCT02712905 An Open-Label, Dose-Escalation/Dose-Expansion Safety Study of INCB059872 in Subjects With Advanced MalignanciesResults posted — 2023-06-12 Trial results posted: NCT04122625 Study to Assess Safety and Efficacy of the Second Mitochondrial-derived Activator of Caspases (SMAC) Mimetic Debio 1143Results posted — 2023-06-13 Trial results posted: NCT02903381 A Phase II Trial If Nivolumab, Lenalidomide and Dexamethasone in High Risk Smoldering MyelomaResults posted — 2023-06-15 Trial results posted: NCT02329847 A Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of the Combination of Ibrutinib With Nivolumab in PaResults posted — 2023-06-15 Trial results posted: NCT03711058 Study of PI3Kinase Inhibition (Copanlisib) and Anti-PD-1 Antibody Nivolumab in Relapsed/Refractory Solid Tumors With Expansions in Mismatch-Results posted — 2023-06-23 Trial results posted: NCT03382561 Cisplatin/Carboplatin and Etoposide With or Without Nivolumab in Treating Patients With Extensive Stage Small Cell Lung CancerResults posted — 2023-06-27 Trial results posted: NCT03816332 Tacrolimus, Nivolumab, and Ipilimumab in Treating Kidney Transplant Recipients With Selected Unresectable or Metastatic CancersResults posted — 2023-06-28 Trial results posted: NCT03495713 Lymphoma RadVax LYMPHOMA: A PHASE II TRIAL OF NIVOLUMAB + LOW DOSE RADIOTHERAPY FOR INCOMPLETE RESPONDERSResults posted — 2023-07-03 Trial results posted: NCT03404960 Niraparib + Ipilimumab or Nivolumab in Progression Free Pancreatic Adenocarcinoma After Platinum-Based ChemotherapyResults posted — 2023-07-10 Trial results posted: NCT03222076 Nivolumab With or Without Ipilimumab in Treating Patients With Resectable Liver CancerResults posted — 2023-07-10 Trial results posted: NCT03190265 Study of CRS-207, Nivolumab, and Ipilimumab With or Without GVAX Pancreas Vaccine (With Cy) in Patients With Pancreatic CancerResults posted — 2023-07-11 Trial results posted: NCT03785210 Nivolumab (Anti-PD1), Tadalafil and Oral Vancomycin in People With Refractory Primary Hepatocellular Carcinoma or Liver Dominant Metastatic Results posted — 2023-07-27 Trial results posted: NCT04099251 Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C MelanomaResults posted — 2023-08-04 Trial results posted: NCT03421652 Nivolumab and RT in Treating Patients With Localized/Locally Advanced Urothelial Bladder Cancer Ineligible for ChemoResults posted — 2023-08-18 Trial results posted: NCT03502330 APX005M With Nivolumab and Cabiralizumab in Advanced Melanoma, Non-small Cell Lung Cancer or Renal Cell CarcinomaResults posted — 2023-08-21 Trial results posted: NCT04119336 Nivolumab, Ixazomib, Cyclophosphamide, and Dexamethasone in Relapsed/Refractory MyelomaResults posted — 2023-08-22 Trial results posted: NCT03695250 BMS-986205 and Nivolumab as First or Second Line Therapy in Treating Patients With Liver CancerResults posted — 2023-08-24 Trial results posted: NCT03606174 A Phase 2 Study of Sitravatinib in Combination With PD-(L)1 Checkpoint Inhibitor Regimens in Patients With Advanced or Metastatic UrothelialResults posted — 2023-08-28 Trial results posted: NCT02658890 An Investigational Immuno-therapy Study of BMS-986205 Given in Combination With Nivolumab and in Combination With Both Nivolumab and IpilimuResults posted — 2023-08-29 Trial results posted: NCT04208958 Study of VE800 and Nivolumab in Patients With Selected Types of Advanced or Metastatic CancerResults posted — 2023-09-21 Trial results posted: NCT02831933 Trial of Radiation and Gene Therapy Before Nivolumab for Metastatic Non-Small Cell Lung Carcinoma and Uveal MelanomaResults posted — 2023-09-21 Trial results posted: NCT02439450 A Study of Combination Therapies With Viagenpumatucel-L (HS-110) in Patients With Non-Small Cell Lung CancerResults posted — 2023-10-03 Trial results posted: NCT03554317 COMbination of Bipolar Androgen Therapy and NivolumabResults posted — 2023-10-26 Trial results posted: NCT03502746 Phase II Nivolumab and Ramucirumab for Patients With Previously-Treated MesotheliomaResults posted — 2023-11-29 Trial results posted: NCT03472586 Ipilimumab and Nivolumab With Immunoembolization in Treating Participants With Metastatic Uveal Melanoma in the LiverResults posted — 2023-12-05 Trial results posted: NCT03123783 CD40 Agonistic Antibody APX005M (Sotigalimab) in Combination With NivolumabResults posted — 2023-12-06 Trial results posted: NCT03229278 Trigriluzole With Nivolumab and Pembrolizumab in Treating Patients With Metastatic or Unresectable Solid Malignancies or LymphomaResults posted — 2023-12-06 Trial results posted: NCT03600350 pTVG-HP and Nivolumab in Patients With Non-Metastatic PSA-Recurrent Prostate CancerResults posted — 2023-12-13 Trial results posted: NCT04899921 Troriluzole or Placebo Plus Ipi Plus Nivo in Mel Brain MetsResults posted — 2023-12-20 Trial results posted: NCT03894891 Induction TPN Followed by Nivolumab With Radiation in Locoregionally Advanced Laryngeal and Hypopharyngeal CancerResults posted — 2023-12-21 Trial results posted: NCT03646123 Clinical Trial of Brentuximab Vedotin in Classical Hodgkin LymphomaResults posted — 2023-12-29 Trial results posted: NCT03749460 Nivolumab and Ipilimumab and Stereotactic Body Radiation Therapy in Treating Patients With Salivary Gland CancersResults posted — 2024-01-03 Trial results posted: NCT05041062 A Study of Immunotherapy Drugs Nivolumab and Ipilimumab in Patients w/Resectable Malignant Peritoneal MesotheliomaResults posted — 2024-01-09 Trial results posted: NCT03420521 Nivolumab With Ipilimumab in Subjects With Neuroendocrine TumorsResults posted — 2024-01-17 Trial results posted: NCT03651271 Nivolumab With or Without Ipilimumab in Advanced Metastatic CancerResults posted — 2024-01-18 Trial results posted: NCT03146650 Nivolumab and Ipilimumab in Treating Patients With Metastatic/Recurrent ACC of All Sites and Non-ACC Salivary Gland CancerResults posted — 2024-01-23 Trial results posted: NCT03484819 Copanlisib Hydrochloride and Nivolumab in Treating Patients With Recurrent or Refractory Diffuse Large B-cell Lymphoma or Primary MediastinaResults posted — 2024-01-30 Trial results posted: NCT03570619 Immunotherapy in Patients With Metastatic Cancers and CDK12 MutationsResults posted — 2024-02-22 Trial results posted: NCT03461952 Nivolumab Ipilimumab in Patients With hyperMutated Cancers Detected in Blood (NIMBLe)Results posted — 2024-02-28 Trial results posted: NCT05005273 A Study to Assess BMS-986207 in Combination With Nivolumab and Ipilimumab as First-line Treatment for Participants With Stage IV Non-Small CResults posted — 2024-03-05 Trial results posted: NCT02247349 BMS-986012 in Relapsed/Refractory SCLCResults posted — 2024-03-12 Trial results posted: NCT04109066 Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Participants With High-riskResults posted — 2024-03-15 Trial results posted: NCT03519308 A Pilot Study of Perioperative Nivolumab and Paricalcitol to Target the Microenvironment in Resectable Pancreatic CancerResults posted — 2024-03-20 Trial results posted: NCT02259621 Neoadjuvant Nivolumab, or Nivolumab in Combination With Ipilimumab, in Resectable NSCLCResults posted — 2024-03-20 Trial results posted: NCT02420912 Nivolumab and Ibrutinib in Treating Patients With Relapsed, Refractory, or High-Risk Untreated Chronic Lymphocytic Leukemia, Small LymphocytResults posted — 2024-04-01 Trial results posted: NCT03342911 Nivolumab, Carboplatin, and Paclitaxel in Treating Patients With Stage III-IV Head and Neck Squamous Cell Carcinoma That Can Be Removed by SResults posted — 2024-04-04 Trial results posted: NCT02978443 A Biomarker Study in Advanced Mucosal or Acral Lentiginous Melanoma Receiving Nivolumab in Combination With IpilimumabResults posted — 2024-04-04 Trial results posted: NCT03310619 A Safety and Efficacy Trial of JCAR017 Combinations in Subjects With Relapsed/Refractory B-cell MalignanciesResults posted — 2024-04-05 Trial results posted: NCT02519322 Neoadjuvant and Adjuvant Checkpoint BlockadeResults posted — 2024-04-10 Trial results posted: NCT04057365 Study of the Combination of DKN-01 and Nivolumab in Previously Treated Patients With Advanced Biliary Tract Cancer (BTC)Results posted — 2024-04-12 Trial results posted: NCT03835533 Platform Study for Prostate Researching Translational Endpoints Correlated to Response to Inform Use of Novel CombinationsResults posted — 2024-04-18 Trial results posted: NCT03311334 A Study of DSP-7888 Dosing Emulsion in Combination With Immune Checkpoint Inhibitors in Adult Patients With Advanced Solid TumorsResults posted — 2024-04-22 Trial results posted: NCT02954991 Phase 2 Study of Glesatinib, Sitravatinib or Mocetinostat in Combination With Nivolumab in Non-Small Cell Lung CancerResults posted — 2024-04-22 Trial results posted: NCT03692325 Safety and Efficacy of Nivolumab in Treating Oral Proliferative Verrucous LeukoplakiaResults posted — 2024-04-25 Trial results posted: NCT03055013 Nivolumab in Treating Patients With Localized Kidney Cancer Undergoing NephrectomyResults posted — 2024-04-29 Trial results posted: NCT03711188 A Study of IMM-101 in Combination With Checkpoint Inhibitor Therapy in Advanced MelanomaResults posted — 2024-05-01 Trial results posted: NCT04396860 Testing the Use of the Immunotherapy Drugs Ipilimumab and Nivolumab Plus Radiation Therapy Compared to the Usual Treatment (Temozolomide andResults posted — 2024-05-03 Trial results posted: NCT01928576 Phase II Anti-PD1 Epigenetic Therapy Study in NSCLC.Results posted — 2024-05-16 Trial results posted: NCT03451331 Gemcitabine + Carboplatin + Nivolumab Versus Gemcitabine + Oxaliplatin + Nivolumab in Cisplatin-ineligible Patients With Metastatic UrotheliResults posted — 2024-05-16 Trial results posted: NCT04331067 Neoadjuvant Nivolumab and Chemotherapy in Patients With Localized Triple-negative Breast CancerResults posted — 2024-05-20 Trial results posted: NCT03562507 Multi-center Trial of ESK981 in Combination With Nivolumab in Patients With Metastatic Renal Cell CarcinomaResults posted — 2024-05-21 Trial results posted: NCT03246958 Nivolumab Plus Ipilimumab in Thyroid CancerResults posted — 2024-05-23 Trial results posted: NCT04655157 Safety and Efficacy in Participants With Metastatic BRAF-mutant Melanoma Treated With Encorafenib With and Without Binimetinib in CombinatioResults posted — 2024-05-29 Trial results posted: NCT02350764 Evaluate the Mediators of Sensitivity and Resistance to Nivolumab Plus Ipilimumab in Patients With Advanced NSCLCsResults posted — 2024-05-30 Trial results posted: NCT04319224 Vopratelimab (JTX-2011) Alone and in Combination With Anti-Programmed Cell Death Protein 1 (PD-1) or Anti-Cytotoxic T-Lymphocyte Antigen 4 (Results posted — 2024-05-31 Trial results posted: NCT02933255 PROSTVAC in Combination With Nivolumab in Men With Prostate CancerResults posted — 2024-06-06 Trial results posted: NCT03817125 Melanoma Checkpoint and Gut Microbiome Alteration With Microbiome InterventionResults posted — 2024-06-11 Trial results posted: NCT01716806 A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL)Results posted — 2024-06-20 Trial results posted: NCT03418922 A Study of Lenvatinib Plus Nivolumab in Participants With Hepatocellular CarcinomaResults posted — 2024-06-25 Trial results posted: NCT03906071 Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung CancerResults posted — 2024-06-27 Trial results posted: NCT04209114 A Study of Nivolumab Plus Bempegaldesleukin (Bempeg/NKTR-214) vs Nivolumab Alone vs Standard of Care in Participants With Bladder Cancer ThaResults posted — 2024-06-27 Trial results posted: NCT03558087 Gemcitabine, Cisplatin, Plus Nivolumab in Patients With Muscle-invasive Bladder Cancer With Selective Bladder SparingResults posted — 2024-06-28 Trial results posted: NCT02949843 Targeted Therapy in Treating Patients With Incurable Non-Small Cell Lung Cancer With Genetic MutationsResults posted — 2024-07-01 Trial results posted: NCT03631641 Nivolumab in Preventing Colon Adenomas in Participants With Lynch Syndrome and a History of Partial ColectomyResults posted — 2024-07-16 Trial results posted: NCT04159896 ESK981 and Nivolumab for the Treatment of Metastatic Castration Resistant Prostate CancerResults posted — 2024-07-18 Trial results posted: NCT03195491 A Study of Non-Small Cell Lung Cancer (NSCLC) Patients Receiving Second-Line Nivolumab Monotherapy in AsiaResults posted — 2024-07-22 Trial results posted: NCT04100018 A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate CancerResults posted — 2024-07-23 Trial results posted: NCT03336216 A Study of Cabiralizumab Given With Nivolumab With and Without Chemotherapy in Patients With Advanced Pancreatic CancerResults posted — 2024-07-23 Trial results posted: NCT04704154 A Trial to Learn Whether Regorafenib in Combination With Nivolumab Can Improve Tumor Responses and How Safe it is for Participants With SoliResults posted — 2024-07-23 Trial results posted: NCT03092674 Azacitidine With or Without Nivolumab or Midostaurin, or Decitabine and Cytarabine Alone in Treating Older Patients With Newly Diagnosed AcuResults posted — 2024-07-23 Trial results posted: NCT04025879 A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant TResults posted — 2024-07-24 Trial results posted: NCT03493932 Cytokine Microdialysis for Real-Time Immune Monitoring in Glioblastoma Patients Undergoing Checkpoint BlockadeResults posted — 2024-08-12 Trial results posted: NCT03620019 Denosumab + PD-1 in Subjects With Stage III/ IV MelanomaResults posted — 2024-08-13 Trial results posted: NCT04778904 First-In-Human Study of ChAdOx1-HBV & MVA-HBV Vaccines (VTP-300) for Chronic HBVResults posted — 2024-08-21 Trial results posted: NCT03639935 Rucaparib in Combination With Nivolumab in Patients With Advanced or Metastatic Biliary Tract Cancer Following Platinum TherapyResults posted — 2024-08-22 Trial results posted: NCT03425331 Biomarkers of Response to Ipilimumab and Nivolumab in First-line NSCLCResults posted — 2024-09-03 Trial results posted: NCT03552380 Study of Entinostat With Nivolumab Plus Ipilimumab in Previously Treated Renal Cell CarcinomaResults posted — 2024-09-05 Trial results posted: NCT03800602 Nivolumab and Metformin in Patients With Treatment Refractory MSS Colorectal CancerResults posted — 2024-09-19 Trial results posted: NCT03453164 Checkpoint Inhibitor and Radiotherapy for Recurrent Gastric Cancer (CIRCUIT)Results posted — 2024-09-19 Trial results posted: NCT05200143 Study of Ipilimumab, Nivolumab, and Cabozantinib in Patients With Cutaneous MelanomaResults posted — 2024-09-19 Trial results posted: NCT03521570 Intensity-Modulated Radiation Therapy & Nivolumab for Recurrent or Second Primary Head & Neck Squamous Cell CancerResults posted — 2024-09-19 Trial results posted: NCT04458909 Testing the Addition of an Anti-cancer Immune Therapy Drug (Nivolumab) to the Usual Chemotherapy Treatment (Cisplatin or Carboplatin With GeResults posted — 2024-10-08 Trial results posted: NCT03583086 Phase I/II Eval Safety & Prelim Activity Nivolumab Comb W/Vorolanib Pts W/Refractory Thoracic TumorsResults posted — 2024-10-08 Trial results posted: NCT04567615 A Study of Relatlimab in Combination With Nivolumab in Participants With Advanced Liver Cancer Who Have Never Been Treated With Immuno-oncolResults posted — 2024-10-09 Trial results posted: NCT03016871 Nivolumab, Ifosfamide, Carboplatin, and Etoposide as Second-Line Therapy in Treating Patients With Refractory or Relapsed HLResults posted — 2024-10-09 Trial results posted: NCT03999749 A Phase II Study of the Interleukin-6 Receptor Inhibitor Tocilizumab in Combination With Ipilimumab and Nivolumab in Patients With UnresectaResults posted — 2024-10-16 Trial results posted: NCT02879695 Blinatumomab and Nivolumab With or Without Ipilimumab in Treating Patients With Poor-Risk Relapsed or Refractory CD19+ Precursor B-LymphoblaResults posted — 2024-10-16 Trial results posted: NCT03038672 Nivolumab With or Without Varlilumab in Treating Patients With Relapsed or Refractory Aggressive B-cell LymphomasResults posted — 2024-10-22 Trial results posted: NCT04277442 Testing Nivolumab in Combination With Decitabine and Venetoclax in Patients With Newly Diagnosed TP53 Gene Mutated Acute Myeloid LeukemiaResults posted — 2024-10-23 Trial results posted: NCT02833233 A Study of Pre-Operative Treatment With Cryoablation and Immune Therapy in Early Stage Breast CancerResults posted — 2024-10-24 Trial results posted: NCT02532231 Nivolumab in AML in Remission at High Risk for RelapseResults posted — 2024-10-26 Trial results posted: NCT03296137 Adoptive Cell Therapy Across Cancer DiagnosesResults posted — 2024-10-29 Trial results posted: NCT03586999 Nivolumab With Standard of Care Chemotherapy for Peripheral T Cell LymphomasResults posted — 2024-10-31 Trial results posted: NCT03929029 Neoantigen Vaccine Plus Locally Administered Ipilimumab and Systemic Nivolumab in Advanced MelanomaResults posted — 2024-11-04 Trial results posted: NCT02397720 Nivolumab and Azacitidine With or Without Ipilimumab in Treating Patients With Refractory/Relapsed or Newly Diagnosed Acute Myeloid LeukemiaResults posted — 2024-11-08 Trial results posted: NCT02046733 Small Cell Lung Carcinoma Trial With Nivolumab and IpiliMUmab in LImited DiseaseResults posted — 2024-11-12 Trial results posted: NCT03575793 A Phase I/II Study of Nivolumab, Ipilimumab and Plinabulin in Patients With Recurrent Small Cell Lung CancerResults posted — 2024-11-19 Trial results posted: NCT03015740 Sitravatinib and Nivolumab in Treating Patients With Advanced or Metastatic Kidney CancerResults posted — 2024-11-21 Trial results posted: NCT03878979 Preoperative Immune Checkpoint Inhibitor for Patients With Primary Untreated or Recurrent/Metastatic SCCHNResults posted — 2024-11-25 Trial results posted: NCT02702492 PAK4 and NAMPT in Patients With Solid Malignancies or NHL (PANAMA)Results posted — 2024-11-26 Trial results posted: NCT04340193 A Study of Nivolumab and Ipilimumab and Nivolumab Alone in Combination With Trans-arterial ChemoEmbolization (TACE) in Participants With IntResults posted — 2024-11-27 Trial results posted: NCT04091750 Nivolumab/Ipilimumab Plus Cabozantinib in Patients With Unresectable Advanced MelanomaResults posted — 2024-12-03 Trial results posted: NCT03487666 OXEL: Immune Checkpoint or Capecitabine or Combination Therapy as Adjuvant Therapy for TNBC With Residual DiseaseResults posted — 2024-12-04 Trial results posted: NCT03081689 Neo-Adjuvant Immunotherapy With Nivolumab for Non Small Cell Lung Cancer PatientsResults posted — 2024-12-10 Trial results posted: NCT02754726 Combination Therapy for Patients With Untreated Metastatic Pancreatic Ductal AdenocarcinomaResults posted — 2024-12-18 Trial results posted: NCT03138512 A Study Comparing Nivolumab, Nivolumab in Combination With Ipilimumab and Placebo in Participants With Localized Kidney Cancer Who UnderwentResults posted — 2024-12-27 Trial results posted: NCT03241745 A Study of Nivolumab in Selected Uterine Cancer PatientsResults posted — 2025-01-09 Trial results posted: NCT03262779 Ipilimumab and Nivolumab in Patients With Anti-PD-1-axis Therapy-resistant Advanced Non-small Cell Lung Cancer.Results posted — 2025-01-13 Trial results posted: NCT03452579 Nivolumab Plus Standard Dose Bevacizumab Versus Nivolumab Plus Low Dose Bevacizumab in GBMResults posted — 2025-01-13 Trial results posted: NCT03980925 Platinum-doublet Chemotherapy and Nivolumab for the Treatment of Subjects With Neuroendocrine Neoplasms (NENs) of the GastroenteropancreaticResults posted — 2025-01-14 Trial results posted: NCT04187833 Nivolumab in Combination With Talazoparib in Melanoma and Mutations in BRCA or BRCA-ness GenesResults posted — 2025-01-14 Trial results posted: NCT04382664 UV1 Vaccination Plus Nivolumab and Ipilimumab in Treatment of MelanomaResults posted — 2025-01-22 Trial results posted: NCT04350463 A Safety and Efficacy Study of CC-90011 in Combination With Nivolumab in Subjects With Advanced CancersResults posted — 2025-01-22 Trial results posted: NCT02960230 H3.3K27M Peptide Vaccine With Nivolumab for Children With Newly Diagnosed DIPG and Other GliomasResults posted — 2025-01-24 Trial results posted: NCT03406871 Regorafenib and Nivolumab Simultaneous Combination TherapyResults posted — 2025-01-27 Trial results posted: NCT03523572 Trastuzumab Deruxtecan With Nivolumab in Advanced Breast and Urothelial CancerResults posted — 2025-01-28 Trial results posted: NCT03642067 Study of Nivolumab and Relatlimab in Patients With Microsatellite Stable (MSS) Advanced Colorectal CancerResults posted — 2025-01-29 Trial results posted: NCT03447470 Study to Evaluate the Safety and Tolerability of RXC004 in Advanced MalignanciesResults posted — 2025-01-31 Trial results posted: NCT04197310 Cabozantinib and Nivolumab for Carcinoid TumorsResults posted — 2025-02-03 Trial results posted: NCT03161379 GVAX Pancreas Vaccine (With CY) in Combination With Nivolumab and SBRT for Patients With Borderline Resectable Pancreatic CancerResults posted — 2025-02-06 Trial results posted: NCT04056910 Ivosidenib (AG-120) With Nivolumab in IDH1 Mutant TumorsResults posted — 2025-02-10 Trial results posted: NCT02927769 A Study of Nivolumab Plus Brentuximab Vedotin in Patients Between 5 and 30 Years Old, With Hodgkin's Lymphoma (cHL), Relapsed or Refractory Results posted — 2025-02-11 Trial results posted: NCT03439891 Sorafenib and Nivolumab in Treating Participants With Unresectable, Locally Advanced or Metastatic Liver CancerResults posted — 2025-02-13 Trial results posted: NCT04552223 Nivolumab Plus Relatlimab in Patients With Metastatic Uveal MelanomaResults posted — 2025-02-17 Trial results posted: NCT03190174 Nivolumab (Opdivo®) Plus ABI-009 (Nab-rapamycin) for Advanced Sarcoma and Certain CancersResults posted — 2025-02-20 Trial results posted: NCT03047928 Combination Therapy With Nivolumab and PD-L1/IDO Peptide Vaccine to Patients With Metastatic MelanomaResults posted — 2025-02-20 Trial results posted: NCT03656718 A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20)Results posted — 2025-02-25 Trial results posted: NCT04322643 Intermittent Checkpoint Inhibitor Therapy In Patients With Advanced Urothelial CarcinomaResults posted — 2025-02-27 Trial results posted: NCT05297565 A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete ResectionResults posted — 2025-03-05 Trial results posted: NCT03158129 Nivolumab With or Without Ipilimumab or Chemotherapy in Treating Patients With Previously Untreated Stage I-IIIA Non-small Cell Lung CancerResults posted — 2025-03-07 Trial results posted: NCT05061017 Pixatimod (PG545) Plus Nivolumab in PD-1 Relapsed/Refractory Metastatic Melanoma and NSCLC and With Nivolumab and Low-dose Cyclophosphamide Results posted — 2025-03-11 Trial results posted: NCT03285321 Unresectable Stage IIIA/IIIB Non-small Cell Lung Cancer (NSCLC)Results posted — 2025-03-11 Trial results posted: NCT03727061 Porfimer Sodium Interstitial Photodynamic Therapy With or Without Standard of Care Chemotherapy in Treating Patients With Locally Advanced oResults posted — 2025-03-17 Trial results posted: NCT04761198 A Study of Etigilimab and Nivolumab in Participants With Locally Advanced or Metastatic TumorsResults posted — 2025-03-18 Trial results posted: NCT05543629 A Study of BMS-986442 With Nivolumab With or Without Chemotherapy in Solid Tumors and Non-small Cell Lung CancerResults posted — 2025-03-18 Trial results posted: NCT04623775 A Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line TreatmentResults posted — 2025-03-25 Trial results posted: NCT03377023 Phase I/II Study of Nivolumab and Ipilimumab Combined With Nintedanib in Non Small Cell Lung CancerResults posted — 2025-03-30 Trial results posted: NCT05834348 A Study to Learn About the Effectiveness of Cancer Medicines in Patients With Metastatic Non-small Cell Lung Cancer in Norway.Results posted — 2025-04-02 Trial results posted: NCT04698187 CMP-001 in Combination With Nivolumab in Subjects With Advanced MelanomaResults posted — 2025-04-03 Trial results posted: NCT04938232 Ipilimumab With or Without Nivolumab in Relapsed/Refractory cHLResults posted — 2025-04-16 Trial results posted: NCT04907539 A Study to Assess Efficacy of RXC004 +/- Nivolumab in Ring Finger Protein 43 (RNF43) or R-spondin (RSPO) Aberrated, Metastatic, MicrosatelliResults posted — 2025-04-16 Trial results posted: NCT06094296 A Study of BMS-986315 and Nivolumab in Combination With Chemotherapy in Participants With First-line Stage IV or Recurrent Non-small Cell LuResults posted — 2025-04-20 Trial results posted: NCT02913313 A Study of BMS-986207 Given Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Advanced Solid TumorsResults posted — 2025-04-22 Trial results posted: NCT03719131 Rituximab and Hyaluronidase Human in Patients With Advanced Melanoma Undergoing Nivolumab and Ipilimumab TherapyResults posted — 2025-04-24 Trial results posted: NCT03110107 First-In-Human Study of Monoclonal Antibody BMS-986218 by Itself and in Combination With Nivolumab in Participants With Advanced Solid TumorResults posted — 2025-04-29 Trial results posted: NCT03689699 Nivolumab and BMS-986253 for Hormone-Sensitive Prostate Cancer (MAGIC-8)Results posted — 2025-04-30 Trial results posted: NCT06003075 Induction Chemo-Nivo in Unresectable Stage III NSCLCResults posted — 2025-05-02 Trial results posted: NCT03952585 De-intensified Radiation Therapy With Chemotherapy (Cisplatin) or Immunotherapy (Nivolumab) in Treating Patients With Early-Stage, HPV-PositResults posted — 2025-05-06 Trial results posted: NCT03107182 Chemotherapy and Locoregional Therapy Trial (Surgery or Radiation) for Patients With Head and Neck CancerResults posted — 2025-05-06 Trial results posted: NCT04526730 Neoadjuvant Immunotherapy With Tavo + Electroporation in Combination With Nivo. in Melanoma PatientsResults posted — 2025-05-11 Trial results posted: NCT03944915 De-Escalation Therapy for Human Papillomavirus Negative DiseaseResults posted — 2025-06-10 Trial results posted: NCT05169684 A Study of BMS-986218 or BMS-986218 Plus Nivolumab in Combination With Docetaxel in Participants With Metastatic Castration-resistant ProstaResults posted — 2025-06-12 Trial results posted: NCT03907488 Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV ClassiResults posted — 2025-06-19 Trial results posted: NCT03400332 A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced CancersResults posted — 2025-06-24 Trial results posted: NCT03522246 A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-BasResults posted — 2025-06-25 Trial results posted: NCT03815942 VAccination in Early and ADvanced Prostate caNCErResults posted — 2025-06-26 Trial results posted: NCT04282109 Study to Assess the Efficacy and Safety of Nivolumab in Combination With Paclitaxel in Subjects With Head and Neck Cancer Unable for CisplatResults posted — 2025-07-10 Trial results posted: NCT03117309 Study of Front Line Therapy With Nivolumab and Salvage Nivolumab + Ipilimumab in Patients With Advanced Renal Cell CarcinomaResults posted — 2025-07-11 Trial results posted: NCT04513522 A Study to Evaluate the Safety and Efficacy of Nivolumab With Ipilimumab in Participants With Untreated Advanced Kidney Cancer Conducted in Results posted — 2025-07-15 Trial results posted: NCT04493203 Nivolumab Plus Axitinib in Patients With Anti-PD1 Refractory Advanced MelanomaResults posted — 2025-07-18 Trial results posted: NCT05116202 A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Melanoma (Morpheus-Melanoma)Results posted — 2025-07-22 Trial results posted: NCT03547999 A Trial of Perioperative CV301 Vaccination in Combination With Nivolumab and Systemic Chemotherapy for Metastatic CRCResults posted — 2025-07-22 Trial results posted: NCT02553642 Relationship Between Tumor Mutation Burden and Predicted Neo-antigen Burden in Patients With Advanced Melanoma or Bladder Cancer Treated WitResults posted — 2025-07-24 Trial results posted: NCT04026412 A Study of Nivolumab and Ipilimumab in Untreated Participants With Stage 3 Non-small Cell Lung Cancer (NSCLC) That is Unable or Not Planned Results posted — 2025-07-24 Trial results posted: NCT04891770 Study to Evaluate the Safety and Efficacy of Selgantolimod (SLGN)-Containing Combination Therapies for the Treatment of Chronic Hepatitis B Results posted — 2025-07-25 Trial results posted: NCT02681302 Check Point Inhibition After Autologous Stem Cell Transplantation in Patients at High Risk of Post Transplant RecurrenceResults posted — 2025-08-06 Trial results posted: NCT03697564 Nivolumab + Cabiralizumab + Gemcitabine in Patients With Stage IV Pancreatic CancerResults posted — 2025-08-06 Trial results posted: NCT03739619 Gemcitabine, Bendamustine, and Nivolumab in Patients With Relapsed or Refractory Classical Hodgkin LymphomaResults posted — 2025-08-12 Trial results posted: NCT04611126 T-cell Therapy in Combination With Nivolumab, Relatlimab and Ipilimumab for Patients With Metastatic Ovarian CancerResults posted — 2025-08-12 Trial results posted: NCT03636477 A Study of Ad-RTS-hIL-12 With Veledimex in Combination With Nivolumab in Subjects With Glioblastoma; a Substudy to ATI001-102Results posted — 2025-09-05 Trial results posted: NCT04695977 CMP-001 in Combination With Nivolumab Compared to Nivolumab Monotherapy in Subjects With Advanced MelanomaResults posted — 2025-09-10 Trial results posted: NCT03937219 Study of Cabozantinib in Combination With Nivolumab and Ipilimumab in Patients With Previously Untreated Advanced or Metastatic Renal Cell CResults posted — 2025-09-15 Trial results posted: NCT03195478 A Study of Nivolumab in Combination With Ipilimumab in Chinese Participants With Previously Treated Advanced or Recurrent Solid TumorsResults posted — 2025-09-16 Trial results posted: NCT04149574 A Study Comparing the Efficacy and Safety of Nivolumab in Combination With Bacillus Calmette-Guerin (BCG) Versus BCG Alone in Participants WResults posted — 2025-09-18 Trial results posted: NCT03446040 An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are AdvResults posted — 2025-09-18 Trial results posted: NCT03036098 Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in TrResults posted — 2025-09-22 Trial results posted: NCT04008030 A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient MismResults posted — 2025-09-23 Trial results posted: NCT02408861 Nivolumab and Ipilimumab in Treating Patients With HIV Associated Relapsed or Refractory Classical Hodgkin Lymphoma or Solid Tumors That AreResults posted — 2025-10-03 Trial results posted: NCT05407675 A Study to Evaluate the Safety and Tolerability of BMS-986408 Alone and in Combination With Nivolumab or Nivolumab and Ipilimumab in ParticiResults posted — 2025-10-09 Trial results posted: NCT03184870 A Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Participants With Advanced Solid TumorsResults posted — 2025-10-10 Trial results posted: NCT03595124 A Study to Compare Treatments for a Type of Kidney Cancer Called TFE/Translocation Renal Cell Carcinoma (tRCC)Results posted — 2025-10-14 Trial results posted: NCT03573947 Phase II Clinical Trial of NIVO-IPI-TAXANE in Untreated Metastatic NSCLCResults posted — 2025-10-16 Trial results posted: NCT04050462 Nivolumab Combined With BMS-986253 in HCC PatientsResults posted — 2025-10-30 Trial results posted: NCT02477826 An Investigational Immuno-therapy Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum-doublet Chemotherapy, CompareResults posted — 2025-10-31 Trial results posted: NCT03914300 Testing the Combination of Cabozantinib, Nivolumab, and Ipilimumab (CaboNivoIpi) for Advanced Differentiated Thyroid CancerResults posted — 2025-11-03 Trial results posted: NCT04205409 Nivolumab for Relapsed, Refractory, or Detectable Disease Post Chimeric Antigen Receptor T-cell Treatment in Patients With Hematologic MaligResults posted — 2025-11-03 Trial results posted: NCT03557359 Nivolumab for Recurrent or Progressive IDH Mutant GliomasResults posted — 2025-11-06 Trial results posted: NCT02275533 Testing Nivolumab to Prevent Disease From Coming Back After Treatment in Patients With Acute Myeloid Leukemia, REMAIN TrialResults posted — 2025-11-06 Trial results posted: NCT02060188 A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has SpreadResults posted — 2025-11-10 Trial results posted: NCT02823990 TG4010 and Nivolumab in Patients With Lung CancerResults posted — 2025-11-12 Trial results posted: NCT03021993 Trial of Nivolumab as a Novel Neoadjuvant Pre-Surgical Therapy for Locally Advanced Oral Cavity CancerResults posted — 2025-11-18 Trial results posted: NCT03369223 A Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid TumorsResults posted — 2025-11-24 Trial results posted: NCT03718767 Nivolumab in Patients With IDH-Mutant Gliomas With and Without Hypermutator PhenotypeResults posted — 2025-12-03 Trial results posted: NCT04021043 BMS-986156, Ipilimumab, and Nivolumab With or Without Stereotactic Body Radiation Therapy in Treating Patients With Advanced or Metastatic LResults posted — 2025-12-03 Trial results posted: NCT03377361 An Investigational Immuno-therapy Study Of Nivolumab In Combination With Trametinib With Or Without Ipilimumab In Participants With PreviousResults posted — 2025-12-03 Trial results posted: NCT03388632 Recombinant Interleukin-15 in Combination With Checkpoint Inhibitors Nivolumab and Ipilimumab in People With Refractory CancersResults posted — 2025-12-12 Trial results posted: NCT03347838 Nivolumab for the Reversal of Squamous Dysplasia in High Risk Current and Former SmokersResults posted — 2025-12-12 Trial results posted: NCT04079712 Testing the Combination of XL184 (Cabozantinib), Nivolumab, and Ipilimumab for Poorly Differentiated Neuroendocrine TumorsResults posted — 2025-12-17 Trial results posted: NCT04349267 Study of BMS-986315 Alone and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid TumorsResults posted — 2025-12-17 Trial results posted: NCT04688658 Duvelisib in Combination With Nivolumab in Patients With Advanced Unresectable MelanomaResults posted — 2025-12-18 Trial results posted: NCT03172624 Study of Nivolumab Plus Ipilimumab in Patients With Salivary Gland CancerResults posted — 2025-12-24 Trial results posted: NCT01658878 An Immuno-therapy Study to Evaluate the Effectiveness, Safety and Tolerability of Nivolumab or Nivolumab in Combination With Other Agents inResults posted — 2026-01-06 Trial results posted: NCT01968109 An Investigational Immuno-therapy Study to Assess the Safety, Tolerability and Effectiveness of Anti-LAG-3 With and Without Anti-PD-1 in theResults posted — 2026-01-08 Trial results posted: NCT04326257 Personalized Immunotherapy in Patients With Recurrent /Metastatic SCCHN That Have Progressed on Prior ImmunotherapyResults posted — 2026-01-08 Trial results posted: NCT05002569 A Study to Assess Adjuvant Immunotherapy With Nivolumab Plus Relatlimab Versus Nivolumab Alone After Complete Resection of Stage III-IV MelaResults posted — 2026-01-12 Trial results posted: NCT03267498 Nivolumab + Chemoradiation in Stage II-IVB Nasopharyngeal Carcinoma (NPC)Results posted — 2026-01-20 Trial results posted: NCT03994601 An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid CancersResults posted — 2026-01-22 Trial results posted: NCT03829722 Radiotherapy, Carboplatin/Paclitaxel and Nivolumab for High Risk HPV-related Head and Neck CancerResults posted — 2026-01-26 Trial results posted: NCT02648997 An Open-Label Phase II Study of Nivolumab or Nivolumab/Ipilimumab in Adult Participants With Progessive/ Recurrent MeningiomaResults posted — 2026-01-30 Trial results posted: NCT04187404 A Novel Therapeutic Vaccine (EO2401) in Metastatic Adrenocortical Carcinoma, or Malignant Pheochromocytoma/ParagangliomaResults posted — 2026-02-12 Trial results posted: NCT05921760 Ivosidenib, Nivolumab, and Ipilimumab Combination in Previously Treated Subjects With Nonresectable or Metastatic IDH1 Mutant CholangiocarciResults posted — 2026-02-13 Trial results posted: NCT03785873 Phase Ib/II Trial of Nal-Irinotecan and Nivolumab as Second-Line Treatment in Patients With Advanced Biliary Tract CancerResults posted — 2026-02-13 Trial results posted: NCT03388190 METIMMOX: Colorectal Cancer METastasis - Shaping Anti-tumor IMMunity by OXaliplatinResults posted — 2026-02-17 Trial results posted: NCT02523469 ALT-803 Plus Nivolumab in Patients With Pretreated, Advanced or Metastatic Non-Small Cell Lung CancerResults posted — 2026-02-18 Trial results posted: NCT02224781 Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in TreatingResults posted — 2026-02-20 Trial results posted: NCT03366766 Nivolumab Plus Cisplatin/Pemetrexed or Cisplatin/Gemcitabine as Induction in Resectable Non-Small Cell Lung CancerResults posted — 2026-02-27 Trial results posted: NCT03358719 DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, Decitabine, and Nivolumab in Treating Patients With Myelodysplastic Syndrome or Acute MResults posted — 2026-03-17 Trial results posted: NCT03799445 Ipilimumab, Nivolumab, and Radiation Therapy in Treating Patients With HPV Positive Advanced Oropharyngeal Squamous Cell CarcinomaResults posted — 2026-03-18 Trial results posted: NCT04902040 Plinabulin in Combination With Radiation/Immunotherapy in Patients With Select Advanced Cancers After Progression on PD-1 or PD-L1 Targeted Results posted — 2026-03-20 Trial results posted: NCT04637594 Trying to Find the Correct Length of Treatment With Immune Checkpoint TherapyResults posted — 2026-03-27 Trial results posted: NCT04785820 A Study of Lomvastomig (RO7121661) and Tobemstomig (RO7247669) Compared With Nivolumab in Participants With Advanced or Metastatic Squamous Results posted — 2026-04-01 Trial results posted: NCT02873962 A Phase II Study Of Nivolumab/ Bevacizumab/RucaparibResults posted — 2026-04-06 Trial results posted: NCT03459222 An Investigational Study of Immunotherapy Combinations in Participants With Solid Cancers That Are Advanced or Have SpreadResults posted — 2026-04-09 Trial results posted: NCT06101134 A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + RelatlResults posted — 2026-04-22 Trial results posted: NCT02314169 Nivolumab With or Without Ipilimumab in Treating Patients With Refractory Metastatic Anal Canal CancerResults posted — 2026-04-22 Trial results posted: NCT03981146 A Phase II Trial Assessing Nivolumab in Class II Expressing Microsatellite Stable Colorectal CancerResults posted — 2026-04-29 Trial results posted: NCT03367741 Cabozantinib S-malate and Nivolumab in Treating Patients With Advanced, Recurrent, or Metastatic Endometrial CancerResults posted — 2026-05-05 Trial results posted: NCT04339738 Testing the Addition of Nivolumab to Chemotherapy in Treatment of Soft Tissue SarcomaResults posted — 2026-05-05 Trial results posted: NCT05144529 A Randomized Pilot Study of Evolocumab Plus Nivolumab/Ipilimumab in Treatment-Naïve Patients With Metastatic NSCLCResults posted — 2026-05-06 Trial results posted: NCT03355560 Adjuvant Nivolumab After Salvage Resection in Head and Neck Cancer Patients Previously Treated With Definitive TherapyResults posted — 2026-05-08 Trial results posted: NCT03637543 Nivolumab in Patients With High-Risk Biochemically Recurrent Prostate CancerResults posted — 2026-05-11 Trial results posted: NCT03767582 Trial of Neoadjuvant and Adjuvant Nivolumab and BMS-813160 With or Without GVAX for Locally Advanced Pancreatic Ductal Adenocarcinomas.Results posted — 2026-05-12 Trial results posted: NCT01703949 Brentuximab Vedotin With or Without Nivolumab in Treating Patients With Relapsed or Refractory CD30+ LymphomaResults posted — 2026-05-15 Trial results posted: NCT04019964 Nivolumab in Biochemically Recurrent dMMR Prostate CancerResults posted — 2026-05-22 Trial results posted: NCT03646461 Trial of Ibrutinib Combined With Nivolumab or Cetuximab to Treat Recurrent/Metastatic HNSCCResults posted — 2026-05-27 Trial results posted: NCT04126070 Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed TumorsResults posted — 2026-05-28 Trial results posted: NCT04514484 Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIVResults posted — 2026-05-29 Trial results posted: NCT02073123 Study of IDO Inhibitor in Combination With Checkpoint Inhibitors for Adult Patients With Metastatic MelanomaResults posted — 2026-06-03 Trial results posted: NCT03958383 IT-hu14.18-IL2 With Radiation, Nivolumab and Ipilimumab for MelanomaResults posted — 2026-06-10 Trial results posted: NCT04879368 RegoNivo vs Standard of Care Chemotherapy in AGOCResults posted — 2026-06-16 Trial results posted: NCT03405155 Nivolumab in Treating Patients With Stage IIB-IIC Melanoma That Can Be Removed by SurgeryResults posted — 2026-06-17 Trial results posted: NCT04702880 A Study of BMS-986012 in Combination With Carboplatin, Etoposide, and Nivolumab as First-line Therapy in Extensive-stage Small Cell Lung CanResults posted — 2026-06-24 Trial results posted: NCT04021108 Phase II Study of Short Course FOLFOX Chemotherapy With Either Nivolumab or Nivolumab + Radiation in the First Line Treatment of Metastatic Results posted — 2026-06-26 Trial results posted: NCT05255601 A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of Relatlimab Plus Nivolumab in Pediatric and Young AdulResults posted — 2026-06-29 Trial results posted: NCT03682276 Safety and Bioactivity of Ipilimumab and Nivolumab Combination Prior to Liver Resection in Hepatocellular CarcinomaResults posted — 2026-07-02 Trial results posted: NCT04401995 Study of TLR9 Agonist Vidutolimod (CMP-001) in Combination With Nivolumab vs. NivolumabResults posted — 2026-07-08 Trial results posted: NCT05715216 EON: A Single-arm Phase II Study of Etigilimab (OMP-313M32) in Combination With Checkpoint Inhibition (Nivolumab) in Patients With Platinum-Results posted — 2026-07-09 Trial results posted: NCT02009449 A Phase 1 Study of Pegilodecakin (LY3500518) in Participants With Advanced Solid TumorsResults posted — 2026-07-17 Trial results posted: NCT03383302 SBRT With Immunotherapy in Early Stage Non-small Cell Lung Cancer: Tolerability and Lung EffectsResults posted — 2026-07-17 Trial results posted: NCT04624178 A Study of Rucaparib and Nivolumab in People With LeiomyosarcomaResults posted — 2026-07-30 Trial results posted: NCT02718066 Study of HBI-8000 With Nivolumab in Melanoma, Renal Cell Carcinoma and Non-Small Cell Lung CancerResults posted — 2026-08-04 Trial results posted: NCT04887870 Study of Sitravatinib With or Without Other Anticancer Therapies Receiving Clinical Benefit From Parent StudyResults posted — 2026-08-06 Trial results posted: NCT03991130 High Dose IL-2 in Combination With Anti-PD-1Results posted — 2026-08-18 Trial results posted: NCT03173950 Immune Checkpoint Inhibitor Nivolumab in People With Recurrent Select Rare CNS CancersResults posted — 2026-08-20 Trial results posted: NCT03274258 Phase II Trial of Nivolumab Plus Ipilimumab in Patients With Renal Medullary CarcinomaResults posted — 2026-08-26 Trial results posted: NCT05625399 A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable MelanomaResults posted — 2026-08-26 Trial results posted: NCT05328908 A Study of Nivolumab-relatlimab Fixed-dose Combination Versus Regorafenib or TAS-102 in Participants With Later-lines of Metastatic ColorectResults posted — 2026-08-27 Trial results posted: NCT05500092 An Open Label, Randomized Study of Neoadjuvant Nivolumab and Chemotherapy, With or Without Sub-ablative Stereotactic Body Radiation Therapy,Pivotal publication — 2024-01-01 Pembrolizumab versus placebo as adjuvant therapy in completely resected stage IIB or IIC melanoma (KEYNOTE-716): a randomised, double-blind, phase 3 trial. (Lancet) Assessment of Short Immunotherapy After Radical Surgery of High-risk Malignant MelanomaPivotal publication — 2024-01-01 Nivolumab+AVD in Advanced-Stage Classic Hodgkin's Lymphoma. (N Engl J Med) Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin LymphomaPivotal publication — 2024-01-01 Perioperative Nivolumab in Resectable Lung Cancer. (N Engl J Med) A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Pivotal publication — 2024-01-01 Tivozanib plus nivolumab versus tivozanib monotherapy in patients with renal cell carcinoma following an immune checkpoint inhibitor: results of the phase 3 TiN (Lancet) Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell CarcinomaPivotal publication — 2025-01-01 Nivolumab plus ipilimumab versus lenvatinib or sorafenib as first-line treatment for unresectable hepatocellular carcinoma (CheckMate 9DW): an open-label, rando (Lancet) CheckMate 9DW — A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular CarcinomaPivotal publication — 2025-01-01 Final, 10-Year Outcomes with Nivolumab plus Ipilimumab in Advanced Melanoma. (N Engl J Med) Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma (CheckMate 067)Pivotal publication — 2025-01-01 Nivolumab plus ipilimumab versus nivolumab in microsatellite instability-high metastatic colorectal cancer (CheckMate 8HW): a randomised, open-label, phase 3 tr (Lancet) CheckMate 8HW — A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) MPivotal publication — 2025-01-01 Overall Survival with Neoadjuvant Nivolumab plus Chemotherapy in Lung Cancer. (N Engl J Med) CheckMate 816 — A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC)Pivotal publication — 2026-01-01 Nivolumab added to cisplatin and radiotherapy versus cisplatin and radiotherapy alone after surgery for people with squamous cell carcinoma of the head and neck (Lancet) NIVOPOSTOP — A Trial Evaluating the Addition of Nivolumab to Cisplatin-RT for Treatment of Cancers of the Head and NeckPivotal publication — 2026-01-01 Nivolumab for Resected Stage III or IV Melanoma at 9 Years. (N Engl J Med) CheckMate 238 — Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanomatoday (2026-09-01)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-09-01Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Nivolumab since 2005, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (221)

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Upcoming & expected milestones

Primary completion· ClinicalTrials.gov
Primary completion: NCT06532149
ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer
Primary completion· ClinicalTrials.gov
Primary completion: NCT07485166
Emulation of the CheckMate 017/057 (NCT01642004 and NCT01673867) Trials Using Specialty Oncology Electronic Health Records Databases
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT07420439
Treatment in Patients With Advanced Non-Small Cell Lung Carcinoma and Interstitial Lung Disease
Primary completion· ClinicalTrials.gov
NA primary completion: NCT02194738
Genetic Testing in Screening Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMI
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT02451982
Platform Study of Neoadjuvant and Adjuvant Immunotherapy for Patients With Resectable Adenocarcinoma of the Pancreas
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT04106414
Study of BMS-986205 and Nivolumab in Endometrial Cancer or Endometrial Carcinosarcoma That Has Not Responded to Treatment
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT07430202
A DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Glutamine Antagonist DRP-104, Nivolumab, and Ipilimumab in Patients With Advance
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT02496208
Cabozantinib S-malate and Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Genitourinary Tumors
Trial started· ClinicalTrials.gov
EARLY_Phase 1 trial started: NCT07741565
Window Trial of Intratumoral (IT) Neoadjuvant Fluorescently Labelled Nivolumab (nivo800) in Head and Neck Squamous Cell Carcinoma (HNSCC)
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT03282344
A Study of NKTR-214 in Combination With Nivolumab in Patients With Metastatic and/or Locally Advanced Sarcoma
Primary completion· ClinicalTrials.gov
NA primary completion: NCT04603248
A Study for Identification of Immune Determinants for Response to Nivolumab in Recurrent and/or Metastatic Head and Neck Squamous Cell Carci
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT05308446
Testing the Addition of Nivolumab to Standard Treatment for Patients With Metastatic or Unresectable Colorectal Cancer That Have a BRAF Muta
Primary completion· ClinicalTrials.gov
Primary completion: NCT07718139
Demographics, Clinical Characteristics and Outcomes in Resected Non-Small Cell Lung Cancer Patients Receiving Immunotherapy in Europe and Ca
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT05361720
Genetic Testing to Select Therapy for the Treatment of Advanced or Metastatic Kidney Cancer, OPTIC RCC Study
Primary completion· ClinicalTrials.gov
Primary completion: NCT07663786
Evaluation of Esophagogastric Cancer Treatment With Nivolumab in Daily Clinical Practice
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT07770100
Concurrent Immunotherapy and Systemic Therapy With Stereotactic Body Radiation Therapy (SBRT) for Stage IV Cancers (COINSSS IV)
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT07551583
Phase 2 Study Of Nivolumab Plus AVD In Pediatric, Adolescent, And Young Adult Patients With CHL
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT06284564
A Phase II Study Bolstering Outcomes by Optimizing Immunotherapy Strategies With Evolocumab and Nivolumab in Patients With Metastatic Renal
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT04561206
Brentuximab Vedotin and Nivolumab for the Treatment of Patients With Relapsed/Refractory Classical Hodgkin Lymphoma
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT04572451
Safety of SBRT With Anti-PD1 and Anti-IL-8 for the Treatment of Multiple Metastases in Advanced Solid Tumors and Melanoma
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT06399419
CBM588 Capsules in Combination With Nivolumab and Ipilimumab for the Treatment of Advanced Stage Kidney Cancer
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT06245356
Safety of Trifluridine/Tipiracil in Patients With Dihydropyrimidine Dehydrogenase Deficiency Diagnosed With Metastatic Colorectal or Gastroe
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT07196384
Optical PD-1 and PD-L1 Imaging in Locally Advanced Esophageal Cancer Using Durvalumab-680LT and Nivolumab-800CW
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT03607890
Study of Nivolumab and Relatlimab in Advanced Mismatch Repair Deficient Cancers Resistant to Prior PD-(L)1 Inhibitor
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT05491616
Nivolumab During Active Surveillance After Neoadjuvant Chemoradiation for Esophageal Cancer: SANO-3 Study
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT04991025
Adding Certolizumab to Chemotherapy + Nivolumab in People Who Have Lung Cancer That Can Be Treated With Surgery
Primary completion· ClinicalTrials.gov
Phase 1/Phase 2 primary completion: NCT05501054
Phase 1b/2 Trial of Ipilimumab, Nivolumab, and Ciforadenant (Adenosine A2a Receptor Antagonist) in First-line Advanced Renal Cell Carcinoma.
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT03884998
Copanlisib and Nivolumab in Treating Patients With Richter's Transformation or Transformed Indolent Non-Hodgkin Lymphoma
Trial started· ClinicalTrials.gov
Phase 4 trial started: NCT07459543
A Study to Assess the Safety, and Tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) In Unresectable or Metastatic Melanoma
Primary completion· ClinicalTrials.gov
Phase 1/Phase 2 primary completion: NCT03233152
A Phase I/II Clinical Trial on the Per-operative Intratumoral Administration of Myeloid Dendritic Cells Plus Ipilimumab and Nivolumab, Follo
Primary completion· ClinicalTrials.gov
Phase 1/Phase 2 primary completion: NCT02955290
CIMAvax Vaccine, Nivolumab, and Pembrolizumab in Treating Patients With Advanced Non-small Cell Lung Cancer or Squamous Head and Neck Cancer

Past events

2026
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT07576725
Low Dose, Reduced Frequency Nivolumab for the Treatment of Unresectable or Metastatic Cancer, AFFORD IO Trial
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07541170
A Study to Evaluate the Efficacy and Safety of Divarasib Compared With Investigator's Choice of Immunotherapy or Observation in Participants
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT07430202
A DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Glutamine Antagonist DRP-104, Nivolumab, and Ipilimumab in Patients With Advance
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT03635892
A Study of Nivolumab In Combination With Cabozantinib in Patients With Non-Clear Cell Renal Cell Carcinoma
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT05568095
A Clinical Trial of a New Combination Treatment, Domvanalimab and Zimberelimab, Plus Chemotherapy, for People With an Upper Gastrointestinal
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT07694986
Trial of Therapies With IT cDC1s Combined w/ IT Trastuzamab for Her+ or IT Nivolumab for Her- BC LMD
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT07444619
A Phase I Study of Pazopanib in Combination With Trabectedin, Ipilimumab and Nivolumab (TraPIN) in Pediatric and Young Adult Patients With R
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT05428007
Interleukin-6 Receptor Inhibitor Sarilumab in Combination With Ipilimumab, Nivolumab and Relatlimab in Patients With Unresectable Stage III
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT02099058
A Study Evaluating the Safety, Pharmacokinetics (PK), and Preliminary Efficacy of ABBV-399 in Participants With Advanced Solid Tumors
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT07476326
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Trial started· ClinicalTrials.gov
Phase 1/Phase 2 trial started: NCT06639607
PEP-CMV + Nivolumab for Newly Diagnosed Diffuse Midline Glioma/High-grade Glioma and Recurrent Diffuse Midline Glioma/High-grade Glioma, Med
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT04462406
Using Biomarkers to Help Guide Safe Immunotherapy Discontinuation in Patients With Unresectable Stage IIIB-IV Melanoma, The PET-Stop Trial
Results posted· ClinicalTrials.gov
Trial results posted: NCT05500092
An Open Label, Randomized Study of Neoadjuvant Nivolumab and Chemotherapy, With or Without Sub-ablative Stereotactic Body Radiation Therapy,
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06319196
Clear Me: Interception Trial to Detect and Clear Molecular Residual Disease in Patients With High-risk Melanoma
Results posted· ClinicalTrials.gov
Trial results posted: NCT05625399
A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma
Results posted· ClinicalTrials.gov
Trial results posted: NCT05328908
A Study of Nivolumab-relatlimab Fixed-dose Combination Versus Regorafenib or TAS-102 in Participants With Later-lines of Metastatic Colorect
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT07664176
NgFUS NIVO: NeuroNavigation-Guided Focused Ultrasound With Nivolumab in Relapsed and Progressive DMG and Other High Grade Brain Tumors
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07700979
Phase 3 Study of Cadonilimab Combined With Chemotherapy vs Chemotherapy in Combination With or Without Nivolumab for the 1L Treatment of Par
Results posted· ClinicalTrials.gov
Trial results posted: NCT03274258
Phase II Trial of Nivolumab Plus Ipilimumab in Patients With Renal Medullary Carcinoma
Results posted· ClinicalTrials.gov
Trial results posted: NCT03173950
Immune Checkpoint Inhibitor Nivolumab in People With Recurrent Select Rare CNS Cancers
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT06968988
Zanzalintinib in Combination With Ipilimumab and Nivolumab in Patients With Metastatic Soft Tissue Sarcoma
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT05601752
ADP-A2M4CD8 Monotherapy and in Combination With Nivolumab in HLA-A2+ Subjects With MAGE-A4 Positive Ovarian Cancer (SURPASS-3)
Results posted· ClinicalTrials.gov
Trial results posted: NCT04887870
Study of Sitravatinib With or Without Other Anticancer Therapies Receiving Clinical Benefit From Parent Study
Primary completion· ClinicalTrials.gov
EARLY_Phase 1 primary completion: NCT03143270
A Study to Test the Safety and Feasibility of Nivolumab With Drug Eluting Bead Transarterial Chemoembolization in Patients With Liver Cancer
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT07460765
Safety and Feasibility of Nivolumab-IRDye800CW in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC)
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06365619
Neoadjuvant Ipilimumab/Nivolumab for Patients With Recurrent, High Risk, Resectable Melanoma
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT04674683
Study Comparing Investigational Drug HBI-8000 + Nivolumab vs. Placebo + Nivolumab in Patients With Advanced Melanoma
Trial started· ClinicalTrials.gov
Phase 1/Phase 2 trial started: NCT07355205
First-Line Ipilimumab Plus Nivolumab and Nogapendekin Alfa Inbakicept (N-803) in Patients With Stage IV or Recurrent Non-Small Cell Lung Can
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT07546812
Study of Denikitug (GS-1811) Given Alone or With Nivolumab or Chemotherapy in Adults With Metastatic Gastric, Gastroesophageal Junction (GEJ
Results posted· ClinicalTrials.gov
Trial results posted: NCT02718066
Study of HBI-8000 With Nivolumab in Melanoma, Renal Cell Carcinoma and Non-Small Cell Lung Cancer
Results posted· ClinicalTrials.gov
Trial results posted: NCT03383302
SBRT With Immunotherapy in Early Stage Non-small Cell Lung Cancer: Tolerability and Lung Effects
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT04080804
Study of Safety and Tolerability of Nivolumab Treatment Alone or in Combination With Relatlimab or Ipilimumab in Head and Neck Cancer
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT07492680
A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Hom
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT04039607
A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma
Results posted· ClinicalTrials.gov
Trial results posted: NCT02009449
A Phase 1 Study of Pegilodecakin (LY3500518) in Participants With Advanced Solid Tumors
Results posted· ClinicalTrials.gov
Trial results posted: NCT05715216
EON: A Single-arm Phase II Study of Etigilimab (OMP-313M32) in Combination With Checkpoint Inhibition (Nivolumab) in Patients With Platinum-
Results posted· ClinicalTrials.gov
Trial results posted: NCT04401995
Study of TLR9 Agonist Vidutolimod (CMP-001) in Combination With Nivolumab vs. Nivolumab
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT03502733
Testing the Combination of Copanlisib, Nivolumab and Ipilimumab in Patients With Advanced Cancer and Lymphoma
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT05867121
A Study to Evaluate Safety, Pharmacokinetics, & Activity of RO7496353 in Combination With a Checkpoint Inhibitor With or Without Standard-of
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT04831320
Nab-Paclitaxel in Combination With Nivolumab to Treat Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma That Progressed on a PD-
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT03646617
Ipilumumab and Nivolumab With or Without Hypofractionated Radiotherapy in Patients With Metastatic Melanoma
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06365619
Neoadjuvant Ipilimumab/Nivolumab for Patients With Recurrent, High Risk, Resectable Melanoma
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT03872947
A Study of TRK-950 in Combinations With Anti-Cancer Treatment Regimens in Patients With Advanced Solid Tumors
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT05568095
A Clinical Trial of a New Combination Treatment, Domvanalimab and Zimberelimab, Plus Chemotherapy, for People With an Upper Gastrointestinal
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT03110978
Stereotactic Body Radiation Therapy With or Without Nivolumab in Treating Patients With Stage I-IIA or Recurrent Non-small Cell Lung Cancer
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT07355205
First-Line Ipilimumab Plus Nivolumab and Nogapendekin Alfa Inbakicept (N-803) in Patients With Stage IV or Recurrent Non-Small Cell Lung Can
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT05504642
Chemo-radio-immunotherapy With Nivolumab and Ipilimumab Treatment in Locally Advanced Cervical Cancer Patients
Trial started· ClinicalTrials.gov
Phase 1/Phase 2 trial started: NCT06639607
PEP-CMV + Nivolumab for Newly Diagnosed Diffuse Midline Glioma/High-grade Glioma and Recurrent Diffuse Midline Glioma/High-grade Glioma, Med
Results posted· ClinicalTrials.gov
Trial results posted: NCT03682276
Safety and Bioactivity of Ipilimumab and Nivolumab Combination Prior to Liver Resection in Hepatocellular Carcinoma
Results posted· ClinicalTrials.gov
Trial results posted: NCT05255601
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of Relatlimab Plus Nivolumab in Pediatric and Young Adul
Results posted· ClinicalTrials.gov
Trial results posted: NCT04021108
Phase II Study of Short Course FOLFOX Chemotherapy With Either Nivolumab or Nivolumab + Radiation in the First Line Treatment of Metastatic
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT06049576
Nivolumab and Ipilimumab With and Without Camu Camu for the Treatment of Patients With Metastatic Renal Cell Carcinoma
Results posted· ClinicalTrials.gov
Trial results posted: NCT04702880
A Study of BMS-986012 in Combination With Carboplatin, Etoposide, and Nivolumab as First-line Therapy in Extensive-stage Small Cell Lung Can
Results posted· ClinicalTrials.gov
Trial results posted: NCT03405155
Nivolumab in Treating Patients With Stage IIB-IIC Melanoma That Can Be Removed by Surgery
Primary completion· ClinicalTrials.gov
Phase 1/Phase 2 primary completion: NCT05267626
Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Met
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT06931613
Autologous Hematopoietic Stem Cell Transplantation in Pediatric Relapsed or Refractory Hodgkin Lymphoma After Nivolumab Treatment
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT07476326
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT07176975
A Study to Test How Well Different Doses of BI 1831169 in Combination With an Anti-PD1 Antibody Are Tolerated in Japanese People With Differ
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT05723055
Evaluating Combination of Nivolumab and Axatilimab in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT07546812
Study of Denikitug (GS-1811) Given Alone or With Nivolumab or Chemotherapy in Adults With Metastatic Gastric, Gastroesophageal Junction (GEJ
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT02451982
Platform Study of Neoadjuvant and Adjuvant Immunotherapy for Patients With Resectable Adenocarcinoma of the Pancreas
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT07369791
Nivolumab Plus Relatlimab and Gemcitabine/Cisplatin as First-Line Treatment in Advanced Biliary Tract Cancer.
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT07529873
Phase II Study of Ficerafusp Alfa in Combination With Nivolumab in Patients With Platinum-refractory Head and Neck Squamous Cell Carcinoma
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT04015778
A Exploratory Study of Nivolumab Monotherapy or in Combination With Nab-paclitaxel and Carboplatin in Early Stage NSCLC in China
Results posted· ClinicalTrials.gov
Trial results posted: NCT02073123
Study of IDO Inhibitor in Combination With Checkpoint Inhibitors for Adult Patients With Metastatic Melanoma
Results posted· ClinicalTrials.gov
Trial results posted: NCT04514484
Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT03383458
A Study of Nivolumab in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ab
Results posted· ClinicalTrials.gov
Trial results posted: NCT03646461
Trial of Ibrutinib Combined With Nivolumab or Cetuximab to Treat Recurrent/Metastatic HNSCC
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT07420439
Treatment in Patients With Advanced Non-Small Cell Lung Carcinoma and Interstitial Lung Disease
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT05836571
Testing Ipilimumab and Nivolumab Combination With or Without Cabozantinib in People >= 18 Years Old With Advanced Soft Tissue Sarcoma
Results posted· ClinicalTrials.gov
Trial results posted: NCT01703949
Brentuximab Vedotin With or Without Nivolumab in Treating Patients With Relapsed or Refractory CD30+ Lymphoma
Results posted· ClinicalTrials.gov
Trial results posted: NCT03767582
Trial of Neoadjuvant and Adjuvant Nivolumab and BMS-813160 With or Without GVAX for Locally Advanced Pancreatic Ductal Adenocarcinomas.
Results posted· ClinicalTrials.gov
Trial results posted: NCT03355560
Adjuvant Nivolumab After Salvage Resection in Head and Neck Cancer Patients Previously Treated With Definitive Therapy
Results posted· ClinicalTrials.gov
Trial results posted: NCT05144529
A Randomized Pilot Study of Evolocumab Plus Nivolumab/Ipilimumab in Treatment-Naïve Patients With Metastatic NSCLC
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT07514767
Evaluation of the Efficacy and Safety of Nivolumab Neoadjuvant Treatment of Patients With Locally Advanced Oral Squamous Cell Carcinoma
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT07510334
VSV-IFNβ-NIS With Ipilimumab and Nivolumab for the Treatment of Advanced or Metastatic Clear Cell Renal Cell Carcinoma
Trial started· ClinicalTrials.gov
Phase 1/Phase 2 trial started: NCT06639607
PEP-CMV + Nivolumab for Newly Diagnosed Diffuse Midline Glioma/High-grade Glioma and Recurrent Diffuse Midline Glioma/High-grade Glioma, Med
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07338981
The Impact of Time-of-day-Dependent Administration of Nivolumab-Ipilimumab (ICI/ICI) Combination on Overall Survival in Adults With Advanced
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT07546812
Study of Denikitug (GS-1811) Given Alone or With Nivolumab or Chemotherapy in Adults With Metastatic Gastric, Gastroesophageal Junction (GEJ
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT07527858
Study of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults With Advanced Colorectal Cancer
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT07460765
Safety and Feasibility of Nivolumab-IRDye800CW in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC)
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT05112601
Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT07188896
A Randomized Trial of Fianlimab and Cemiplimab +/- Ipilimumab or Ipilimumab Plus Nivolumab in First-line Advanced Renal Cell Carcinoma (RCC)
Results posted· ClinicalTrials.gov
Trial results posted: NCT03367741
Cabozantinib S-malate and Nivolumab in Treating Patients With Advanced, Recurrent, or Metastatic Endometrial Cancer
Results posted· ClinicalTrials.gov
Trial results posted: NCT02314169
Nivolumab With or Without Ipilimumab in Treating Patients With Refractory Metastatic Anal Canal Cancer
Results posted· ClinicalTrials.gov
Trial results posted: NCT03981146
A Phase II Trial Assessing Nivolumab in Class II Expressing Microsatellite Stable Colorectal Cancer

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.