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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from approximately 20 weeks up to approximately 72 months
Awards & highlights
KEYNOTE-866 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.Check my eligibility
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.See study design
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.
KEYNOTE-866 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My bladder cancer has not spread beyond my pelvis, confirmed by scans.
Select...
I am fully active or can carry out light work.
Select...
My bladder cancer is mostly urothelial and confirmed by tissue analysis.
KEYNOTE-866 Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Event-Free Survival (EFS)
Secondary outcome measures
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 moreKEYNOTE-866 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
Cisplatin
2013
Completed Phase 3
~1940
Pembrolizumab
2017
Completed Phase 2
~2010
Gemcitabine
2017
Completed Phase 3
~2070
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,053,664 Total Patients Enrolled
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,580,915 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,062,573 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot receive cisplatin due to specific health reasons.I have received an organ or tissue transplant from another person.My bladder cancer has not spread beyond my pelvis, confirmed by scans.I have been diagnosed with an immunodeficiency or have HIV, Hepatitis B, or active Hepatitis C.I have another cancer besides the one being studied, but it hasn't needed treatment in the last 3 years.I am fully active or can carry out light work.I had surgery to remove part of my bladder for cancer.I have had treatment for bladder cancer but not with specific immune therapies.I agree to follow the study's rules for using birth control.I have had cancer treatment or experimental drugs within the last 3 years or radiation to the bladder.I have not had a live vaccine in the last 30 days.My bladder cancer is mostly urothelial and confirmed by tissue analysis.You have a known mental health or drug abuse problem.My organs are functioning well.I am considered a candidate for surgery to remove my bladder and nearby lymph nodes.My cancer has spread to nearby lymph nodes or other parts of my body.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab + Gemcitabine + Cisplatin + Surgery
- Group 2: Placebo + Gemcitabine + Cisplatin + Surgery
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
For what purpose is Cisplatin most frequently given to patients?
"Cisplatin has been shown to be effective in treating relapsed mediastinal large b-cell lymphoma, as well as other cancers including urinary bladder cancer, advanced testicular cancer, and small cell lung cancer."
Answered by AI
What is the scientific research community's experience with Cisplatin?
"The first clinical trial for cisplatin was at City of Hope Comprehensive Cancer Center in 1997. Since then, there have been over 20,000 completed studies on the medication. Currently, there are 1895 trials recruiting patients with many of these taking place in Tulsa, Oklahoma."
Answered by AI
Are there a significant number of sites running this trial in North America?
"There are 13 enrolling sites for this clinical trial, which include Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0021) in Tulsa, Oklahoma, Allegheny General Hospital ( Site 0048) in Pittsburgh, Pennsylvania, and Kingston Health Sciences Centre ( Site 0103) in Kingston, Ontario."
Answered by AI
Could you give me an estimate for how many people will be participating in this trial?
"The most recent update on this trial was on August 18th, 2022, which indicates that it is no longer actively enrolling patients. However, there are presently 328 studies actively enrolling patients with urinary bladder and 1895 trials for Cisplatin admitting patients."
Answered by AI
Are there long-term risks to Cisplatin treatment?
"Cisplatin is considered safe according to our internal 3-point scale."
Answered by AI
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