Perioperative Pembrolizumab (MK-3475) Plus Neoadjuvant Chemotherapy Versus Perioperative Placebo Plus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle-invasive Bladder Cancer (MIBC) (MK-3475-866/KEYNOTE-866)

Part of paid clinical trials in La Jolla, California.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT03924856
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Pembrolizumab — DRUG
    Pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle
  • Gemcitabine — DRUG
    Gemcitabine 1000 mg/m\^2, IV infusion on Days 1 and 8 of each 21-day cycle
  • Cisplatin — DRUG
    Cisplatin 70 mg/m\^2, IV infusion on Day 1 of each 21-day cycle
  • Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND]) — PROCEDURE
    Surgical RC+PLND will be done in accordance with the American Urological Association (AUA)/American Society of Clinical Oncology (ASCO)/American Society for Radiation Oncology (ASTRO)/Society of Urologic Oncology (SUO) guidelines.
  • Placebo — DRUG
    Placebo to pembrolizumab by IV infusion, given on Day 1 of each 21-day cycle

Study Details

A global study to evaluate peri-operative pembrolizumab with chemotherapy versus placebo to pembrolizumab plus chemotherapy in cisplatin eligible patients.

Key Dates

Start date
Jun 13, 2019
Status verified
May 2026
Primary completion
Jan 26, 2026
Completion
May 18, 2026

Study Design

Enrollment
907 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab + Gemcitabine + Cisplatin + Surgery
    Participants received 4 preoperative cycles of pembrolizumab PLUS gemcitabine PLUS cisplatin, followed by surgery, followed by up to 13 cycles of postoperative pembrolizumab.
  • Placebo Comparator: Placebo + Gemcitabine + Cisplatin + Surgery
    Participants received 4 preoperative cycles of placebo to pembrolizumab PLUS gemcitabine PLUS cisplatin, followed by surgery, followed by up to 13 cycles of postoperative placebo to pembrolizumab.

Primary Outcome Measure

Event-Free Survival (EFS) [ Time Frame: Up to approximately 60 months ]

Locations (24)

FacilityCityStateZIPSite coordinators
Scripps MD Anderson ( Site 0010)La JollaCalifornia92037-
Providence Saint John's Health Center ( Site 0075)Santa MonicaCalifornia90404-
Georgetown University Medical Center ( Site 0022)Washington D.C.District of Columbia20007-
AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0005)OrlandoFlorida32804-
Parkview Cancer Institute ( Site 0077)Fort WayneIndiana46845-
Indiana University Melvin and Bren Simon Cancer Center ( Site 0004)IndianapolisIndiana46202-
Ochsner Medical Center ( Site 0049)New OrleansLouisiana70121-
New England Cancer Specialists ( Site 0070)ScarboroughMaine04074-
UMass Memorial Medical Center ( Site 0051)WorcesterMassachusetts01655-
Henry Ford Hospital ( Site 0039)DetroitMichigan48202-
Mercy Hospital Saint Louis ( Site 0064)St LouisMissouri63141-
Morristown Medical Center ( Site 0015)MorristownNew Jersey07960-
UNM Comprehensive Cancer Center-Clinical Research Office ( Site 0045)AlbuquerqueNew Mexico87106-
New York University Perlmutter Cancer Center ( Site 0008)New YorkNew York10016-
University Hospitals Cleveland Medical Center ( Site 0038)ClevelandOhio44106-
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0021)TulsaOklahoma74146-
Portland VA Medical Center ( Site 0084)PortlandOregon97239-
Allegheny General Hospital ( Site 0048)PittsburghPennsylvania15212-
MD Anderson Cancer Center ( Site 0063)HoustonTexas77030-
Central Texas Veterans Healthcare System ( Site 0057)TempleTexas76504-
Inova Schar Cancer Institute ( Site 0007)FairfaxVirginia22031-
Northwest Medical Specialties, PLLC ( Site 0061)PuyallupWashington98373-
Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 0033)SeattleWashington98109-
Charleston Area Medical Center ( Site 0023)Charles TownWest Virginia25304-

Related coverage on Hipa.ai

Find similar trials in La Jolla, CA

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Scripps MD Anderson· La Jolla, CAProvidence Saint John's Health Center· Santa Monica, CAGeorgetown University Medical Center· Washington D.C., DCAdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando· Orlando, FLParkview Cancer Institute· Fort Wayne, INIndiana University Melvin and Bren Simon Cancer Center· Indianapolis, IN

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