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)

Completed · Phase 3 · Has a placebo group

Conditions studied: Bladder Cancer

In brief

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

Key facts

Study ID

NCT03924856

Run by

Merck Sharp & Dohme LLC

People needed

907

Starts

2019-06-13

Expected to finish

2026-06-11

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have a histologically confirmed diagnosis of urothelial carcinoma (UC) / muscle invasive bladder cancer (MIBC) (T2-T4aN0M0 or T1-T4aN1M0) with predominant (≥50%) urothelial histology.
• Have clinically non-metastatic bladder cancer (N≤1 M0) determined by imaging (computed tomography (CT) or magnetic resonance imaging (MRI)) of the chest/abdomen/pelvis.
• Be deemed eligible for Radical Cystectomy (RC) + Pelvic Lymph Node Dissection (PLND).
• Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Have adequate organ function.
• Male and female participants are eligible to participate if they agree to the contraception use as per study protocol.

You may not qualify if…

• Has a known additional malignancy that is progressing or has required active anti-cancer treatment ≤3 years of study randomization with certain exceptions.
• Has received any prior systemic treatment for MIBC or non-invasive muscle bladder cancer (NMIBC - prior treatment for NMIBC with intravesical BCG/chemotherapy is permitted) or prior therapy with an anti- programmed cell death 1 (PD-1), anti-programmed cell death ligand 1/ ligand 2 (PD-L1/L2), or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4).
• Has ≥N2 disease or metastatic disease (M1) as identified by imaging.
• Is cisplatin-ineligible, as defined by meeting any one of the cisplatin ineligibility criteria as per protocol.
• Has received prior systemic anticancer therapy including investigational agents within 3 years of randomization or any radiotherapy to the bladder.
• Has undergone partial cystectomy of the bladder to remove any NMIBC or MIBC.
• Has received a live or live attenuated vaccine within 30 days before the first dose of study intervention.
• Has a diagnosis of immunodeficiency or has a known history of human immunodeficiency virus (HIV) infection, Hepatitis B infection or known active Hepatitis C infection.
• Has a known psychiatric or substance abuse disorder.
• Has had an allogenic tissue/solid organ transplant.

Where it is running

• Providence Saint John's Health Center ( Site 0075) — Santa Monica, California, United States
• Georgetown University Medical Center ( Site 0022) — Washington D.C., District of Columbia, United States
• AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0005) — Orlando, Florida, United States
• Parkview Cancer Institute ( Site 0077) — Fort Wayne, Indiana, United States
• Indiana University Melvin and Bren Simon Cancer Center ( Site 0004) — Indianapolis, Indiana, United States
• Ochsner Medical Center ( Site 0049) — New Orleans, Louisiana, United States
• New England Cancer Specialists ( Site 0070) — Scarborough, Maine, United States
• UMass Memorial Medical Center ( Site 0051) — Worcester, Massachusetts, United States
• Henry Ford Hospital ( Site 0039) — Detroit, Michigan, United States
• Mercy Hospital Saint Louis ( Site 0064) — St Louis, Missouri, United States
• Morristown Medical Center ( Site 0015) — Morristown, New Jersey, United States
• UNM Comprehensive Cancer Center-Clinical Research Office ( Site 0045) — Albuquerque, New Mexico, United States
• New York University Perlmutter Cancer Center ( Site 0008) — New York, New York, United States
• University Hospitals Cleveland Medical Center ( Site 0038) — Cleveland, Ohio, United States
• Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0021) — Tulsa, Oklahoma, United States
• Portland VA Medical Center ( Site 0084) — Portland, Oregon, United States
• Allegheny General Hospital ( Site 0048) — Pittsburgh, Pennsylvania, United States
• MD Anderson Cancer Center ( Site 0063) — Houston, Texas, United States
• Central Texas Veterans Healthcare System ( Site 0057) — Temple, Texas, United States
• Inova Schar Cancer Institute ( Site 0007) — Fairfax, Virginia, United States
• Northwest Medical Specialties, PLLC ( Site 0061) — Puyallup, Washington, United States
• Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 0033) — Seattle, Washington, United States
• Charleston Area Medical Center ( Site 0023) — Charles Town, West Virginia, United States
• Mid North Coast Cancer Institute ( Site 1256) — Port Macquarie, New South Wales, Australia
• Scripps MD Anderson ( Site 0010) — La Jolla, California, United States

Full record on ClinicalTrials.gov

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