Pembrolizumab + Chemoradiotherapy for Bladder Cancer
What You Need to Know Before You Apply
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.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy or have received certain treatments like live vaccines recently, you may need to discuss this with the trial team.
Is the combination of Pembrolizumab and Chemoradiotherapy safe for treating bladder cancer?
Pembrolizumab, used for bladder cancer, is generally well tolerated with main side effects including tiredness, low white blood cell count, anemia (low red blood cells), muscle pain, reduced appetite, and nausea. It offers a safer alternative for patients who cannot tolerate cisplatin-based chemotherapy.12345
What makes the Pembrolizumab + Chemoradiotherapy treatment for bladder cancer unique?
This treatment combines pembrolizumab, an immune system-boosting drug, with chemoradiotherapy, offering a new option for bladder cancer patients who cannot tolerate standard cisplatin-based chemotherapy. Pembrolizumab works by helping the immune system attack cancer cells, providing an alternative for those ineligible for traditional treatments.23678
What data supports the effectiveness of the treatment Pembrolizumab + Chemoradiotherapy for Bladder Cancer?
Pembrolizumab, a type of immunotherapy, has shown effectiveness as a treatment for bladder cancer, especially for patients who cannot tolerate cisplatin-based chemotherapy. It works by helping the immune system attack cancer cells, and has been approved for use in patients with advanced bladder cancer who are ineligible for cisplatin.125910
Who Is on the Research Team?
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pembrolizumab or placebo in combination with chemoradiotherapy (CRT)
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cisplatin
- Conventional Radiotherapy (Bladder and pelvic nodes)
- Conventional Radiotherapy (Bladder only)
- Fluorouracil (5-FU)
- Hypofractionated Radiotherapy (Bladder only)
- Mitomycin C (MMC)
- Pembrolizumab
Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme Corp.
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme Corp.
Chief Medical Officer
Engineering degree from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme Corp.
Chief Executive Officer since 2021
J.D. from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
Merck Sharp & Dohme LLC
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University