Pembrolizumab + Chemotherapy for Bladder Cancer
(KEYNOTE-866 Trial)

Recruiting in Palo Alto (17 mi)

+179 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Merck Sharp & Dohme LLC

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for adults with muscle-invasive bladder cancer who are eligible for cisplatin and surgery. They must have good organ function, agree to use contraception, and have a performance status of 0 or 1. Excluded are those with certain psychiatric disorders, recent live vaccines, other active cancers within the last three years (with exceptions), prior treatments for MIBC or specific immunotherapies, advanced disease stages beyond N1M0, cisplatin ineligibility, recent anticancer therapies or radiotherapy to the bladder.

Inclusion Criteria

My bladder cancer has not spread beyond my pelvis, confirmed by scans.

I am fully active or can carry out light work.

I agree to follow the study's rules for using birth control.

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Exclusion Criteria

I cannot receive cisplatin due to specific health reasons.

I have received an organ or tissue transplant from another person.

I have been diagnosed with an immunodeficiency or have HIV, Hepatitis B, or active Hepatitis C.

See 7 more

Treatment Details

Interventions

Cisplatin (Alkylating agents)
Gemcitabine (Chemotherapy)
Pembrolizumab (Monoclonal Antibodies)
Placebo (Immunotherapy)
Radical Cystectomy Plus Pelvic Lymph Node Dissection (Surgery)

Trial OverviewThe study tests if adding pembrolizumab (an immune therapy drug) to standard chemotherapy before and after bladder removal surgery is better than placebo plus chemotherapy. Participants will be randomly assigned to receive either pembrolizumab or a placebo alongside their chemo regimen.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Pembrolizumab + Gemcitabine + Cisplatin + SurgeryExperimental Treatment4 Interventions

Participants received 4 preoperative cycles of pembrolizumab PLUS gemcitabine PLUS cisplatin, followed by surgery, followed by up to 13 cycles of postoperative pembrolizumab.

Group II: Placebo + Gemcitabine + Cisplatin + SurgeryPlacebo Group4 Interventions

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.

Cisplatin is already approved in Canada, Japan for the following indications: