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Alkylating agents

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

Phase 3

Waitlist Available

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Must not have

Is cisplatin-ineligible, as defined by meeting any one of the cisplatin ineligibility criteria as per protocol

Has had an allogenic tissue/solid organ transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from approximately 20 weeks up to approximately 72 months

Awards & highlights

Pivotal Trial

Summary

This trial is testing whether adding the immunotherapy drug pembrolizumab to standard chemotherapy can help treat patients with certain types of cancer.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Pembrolizumab may cause immune-related side effects such as inflammation in various organs like lungs and intestines, skin reactions, hormone gland problems (like thyroid), liver issues; also possible are infusion reactions during administration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am fully active or can carry out light work.

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My bladder cancer is mostly urothelial and confirmed by tissue analysis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot receive cisplatin due to specific health reasons.

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

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

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I had surgery to remove part of my bladder for cancer.

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I have had treatment for bladder cancer but not with specific immune therapies.

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I have had cancer treatment or experimental drugs within the last 3 years or radiation to the bladder.

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My cancer has spread to nearby lymph nodes or other parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from approximately 20 weeks up to approximately 72 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from approximately 20 weeks up to approximately 72 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from approximately 20 weeks up to approximately 72 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Event-Free Survival (EFS)

Secondary study objectives

Change in Patient-Reported Outcomes from Baseline in EuroQol Five-Dimensional Questionnaire (EQ-5D-5L) Visual Analog Score (VAS)

Change in Patient-Reported Outcomes from Baseline in FACT-BI-Cys-Trial Outcome Index (TOI)

Change in Patient-Reported Outcomes from Baseline in Total Score of FACT-Bladder- (FACT-BI-Cys)

+10 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~2810

Gemcitabine

2017

Completed Phase 3

~1920