Study on Pembrolizumab and Other Investigational Drugs for High Risk Non-Muscle Invasive Bladder Cancer

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT02625961

This clinical trial is testing the effectiveness of pembrolizumab, alone or with other investigational drugs, in patients with high risk non-muscle invasive bladder cancer that has not responded to BCG therapy and who cannot or choose not to have bladder removal surgery.

Patient Parameters

Program Overview

The study aims to find out if pembrolizumab, a type of immunotherapy, can help treat high risk non-muscle invasive bladder cancer (NMIBC) that hasn't responded to BCG treatment. Participants who are not eligible for or have refused bladder removal surgery will receive pembrolizumab alone or in combination with other investigational drugs. The main goal is to see if this treatment can provide a meaningful response in controlling the cancer.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with high risk non-muscle invasive bladder cancer, specifically types like T1, high grade Ta, or carcinoma in situ (CIS).
  • Cancer must be fully removed at the start of the study, except for CIS.
  • Cancer did not respond to adequate BCG therapy.
  • Not eligible for or have refused bladder removal surgery.
  • Must provide a new biopsy sample from a tumor that hasn't been treated with radiation.
  • Have a performance status score of 0, 1, or 2, indicating good overall health.
  • Have adequate organ function.
  • Women of childbearing age must have a negative pregnancy test and agree to use contraception.
  • Men must agree to use contraception.

Exclusion Criteria

  • Have muscle-invasive, advanced, or metastatic bladder cancer.
  • Have cancer in other parts of the urinary system like the urethra or kidneys.
  • Currently in another study or have been in one recently.
  • Have had chemotherapy or immunotherapy in the bladder recently.
  • Have had other cancer treatments recently or not recovered from past treatment side effects.
  • Have another progressing cancer needing treatment, except for certain skin cancers or treated prostate cancer.
  • Have an active autoimmune disease needing treatment in the past 2 years.
  • Have lung disease or active lung inflammation.
  • Have an active infection needing treatment.
  • Are pregnant, breastfeeding, or planning to conceive soon.
  • Have had previous treatment with certain immune therapies.
  • Have HIV, active Hepatitis B or C.
  • Have had a live vaccine recently.
  • Have had a tissue or organ transplant.

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