Pembrolizumab + Chemoradiotherapy for Bladder Cancer

Recruiting in Palo Alto (17 mi)

+146 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Merck Sharp & Dohme Corp.

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?Researchers are looking for new ways to treat muscle-invasive bladder cancer (MIBC). MIBC is a type of cancer that has not spread from the muscles in the bladder to other parts of the body. MIBC is treated by having surgery to remove the bladder (cystectomy). Not all people choose to have surgery and want to keep their bladder using other treatments. Chemoradiotherapy (CRT)- is a type of non-surgical treatment for MIBC which combines Chemotherapy (a treatment with medicine to destroy cancer cells or stop them growing) and Radiation therapy (a treatment that uses beams of intense energy \[like X-rays\] to shrink or get rid of tumors). Pembrolizumab is an immunotherapy, which is a treatment that helps the immune system fight cancer. A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand if the study medicine works. The goal of this study is to learn: 1. If a study medicine pembrolizumab given with Chemoradiotherapy (CRT) can help people live longer without their cancer growing, spreading, or coming back compared to placebo given with CRT. 2.About the safety and how well people tolerate CRT alone or in combination with pembrolizumab.

Eligibility Criteria

This trial is for adults with muscle-invasive bladder cancer who are set to receive chemoradiotherapy and meet certain health criteria, including good organ function and performance status. Women must not be pregnant or breastfeeding and follow specific contraceptive guidelines; men must agree to use contraception or abstain from heterosexual intercourse.

Inclusion Criteria

My organs are functioning well.

My bladder cancer was confirmed to be invasive and mainly urothelial.

I can take care of myself and am up and about more than half of my waking hours.

+4 more

Exclusion Criteria

I have an autoimmune disease treated with medication in the last 2 years.

Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study

You have a severe allergy to the specific treatments or any of their ingredients.

+16 more

Participant Groups

The study tests the effectiveness of pembrolizumab (a type of immunotherapy) combined with chemoradiotherapy versus just chemoradiotherapy in treating bladder cancer. The goal is to see if adding pembrolizumab improves survival without the cancer spreading or worsening.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Pembrolizumab + Chemotherapy + RadiotherapyExperimental Treatment8 Interventions

Participants receive pembrolizumab plus one of three chemotherapy regimens chosen by investigator, plus one of three radiotherapy regimens chosen by investigator.

Group II: Placebo + Chemotherapy + RadiotherapyPlacebo Group8 Interventions

Participants receive placebo to pembrolizumab plus one of three chemotherapy regimens chosen by investigator, plus one of three radiotherapy regimens chosen by investigator.

Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Platinol for: