Study on the Effectiveness and Safety of Pembrolizumab with Chemoradiotherapy Compared to Chemoradiotherapy Alone in Muscle-Invasive Bladder Cancer

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04241185

Provider View

This clinical trial is exploring whether adding the immunotherapy drug pembrolizumab to standard chemoradiotherapy can help people with muscle-invasive bladder cancer live longer without their cancer growing or returning. The study also aims to understand the safety and tolerance of these treatments.

Patient Parameters

Program Overview

Researchers are investigating new treatments for muscle-invasive bladder cancer (MIBC), a type of cancer that affects the bladder muscles but hasn't spread to other parts of the body. Typically, MIBC is treated with surgery to remove the bladder, but not everyone opts for surgery. Instead, some choose chemoradiotherapy (CRT), which combines chemotherapy and radiation therapy to target cancer cells. This study is testing if adding pembrolizumab, an immunotherapy drug that helps the immune system fight cancer, to CRT can improve outcomes compared to CRT alone. A placebo, which looks like the study drug but contains no active medicine, is used to help researchers determine the effectiveness of pembrolizumab. The main goals are to see if pembrolizumab with CRT can help patients live longer without cancer progression and to assess the safety and tolerance of these treatments.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with muscle-invasive bladder cancer (MIBC) with a specific type of cell structure.
  • Cancer has not spread beyond the bladder (nonmetastatic).
  • Eligible and planning to receive chemoradiotherapy (CRT) with one of the specified chemotherapy regimens.
  • General health status allows participation, with an ECOG performance status of 0, 1, or 2.
  • Adequate organ function based on medical tests.
  • Male participants must agree to avoid donating sperm and use contraception or remain abstinent during the study and for 90 days after the last CRT dose.
  • Female participants must not be pregnant or breastfeeding and must use effective contraception or be abstinent during the study and for 180 days after the last dose of study treatment. They must also agree not to donate eggs during this period.

Exclusion Criteria

  • Widespread carcinoma in situ (CIS) throughout the bladder.
  • Urothelial carcinoma outside the bladder in the past 2 years, except for certain treated cases.
  • Another progressing cancer or one that required treatment in the past 3 years, except for specific non-threatening cancers.
  • Bilateral hydronephrosis (swelling of kidneys due to urine buildup).
  • Limited bladder function or need for catheterization.
  • Previous pelvic radiation or treatment for muscle-invasive bladder cancer, except for certain completed treatments for non-muscle invasive bladder cancer.
  • Prior treatment with specific immune therapies or investigational agents.
  • Recent live vaccine or participation in another clinical trial.
  • Severe allergy to chemotherapy or pembrolizumab components.
  • Immunodeficiency or use of high-dose steroids or immunosuppressive therapy recently.
  • Active autoimmune disease needing treatment in the past 2 years, except for certain replacement therapies.
  • History of lung inflammation needing steroids or current lung inflammation.
  • Active infection needing treatment.
  • Known HIV, hepatitis B, or active hepatitis C infection.
  • History of active tuberculosis.
  • Psychiatric or substance abuse issues affecting study participation.
  • Previous organ transplant.

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