Using a Targeted Cancer Vaccine (Galinpepimut-S) With Immunotherapy (Nivolumab) in Mesothelioma

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT04040231
Phase
PHASE1
Status
Completed

Conditions

  • Mesothelioma
  • Pleural Mesothelioma
  • Wilms Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Galinpepimut-S — BIOLOGICAL
    Galinpepimut-S will be administered alone on weeks 0 and 2. Participants will receive the galinpepimut-S vaccine and nivolumab over 16 weeks in the initial treatment phase.
  • Nivolumab — DRUG
    Participants will receive nivolumab and the galinpepimut-S vaccine over 16 weeks in the initial treatment phase.
  • Sargramostim — BIOLOGICAL
    All participants will receive Sargramostim (GM-CSF) 70 mcg injected subcutaneously on days 0 and -2 of each cycle

Study Details

The purpose of this study is to test whether it is safe to give Galinpepimut-S and Nivolumab together in patients with mesothelioma.

Key Dates

Start date
Jul 24, 2019
Status verified
Nov 2024
Primary completion
Nov 14, 2024
Completion
Nov 14, 2024

Study Design

Enrollment
10 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Malignant Pleural Mesothelioma (MPM)
    Participants with previously treated Malignant Pleural Mesothelioma/MPM

Primary Outcome Measure

Maximum tolerated dose [ Time Frame: up to 24 months ]

Locations (6)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking RidgeBasking RidgeNew Jersey07920-
Memorial Sloan Kettering MonmouthMiddletownNew Jersey07748-
Memorial Sloan Kettering Cancer Center @ CommackCommackNew York11725-
Memorial Sloan Kettering WestchesterHarrisonNew York10604-
Memorial Sloan - Kettering Cancer CenterNew YorkNew York10021-
Memorial Sloan Kettering NassauUniondaleNew York11553-

Find similar trials in Basking Ridge, NJ

By research site
Memorial Sloan Kettering Basking Ridge· Basking Ridge, NJMemorial Sloan Kettering Monmouth· Middletown, NJMemorial Sloan Kettering Cancer Center @ Commack· Commack, NYMemorial Sloan Kettering Westchester· Harrison, NYMemorial Sloan - Kettering Cancer Center· New York, NYMemorial Sloan Kettering Nassau· Uniondale, NY

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