Study on Nivolumab Immunotherapy vs. Placebo for Bladder or Upper Urinary Tract Cancer After Surgery

Sponsor: Bristol-Myers Squibb

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT02632409

Provider View

This clinical trial is testing whether the immunotherapy drug Nivolumab is more effective and safe compared to a placebo in patients who have had surgery to remove invasive bladder or upper urinary tract cancer.

Patient Parameters

Program Overview

The aim of this study is to find out if Nivolumab, an immunotherapy drug, is better at preventing the return of cancer compared to a placebo in patients who have had surgery to remove invasive urothelial cancer from the bladder, ureter, or renal pelvis. The study will assess both the effectiveness and safety of Nivolumab in these patients.

Eligibility Criteria

Inclusion Criteria

  • Previously had invasive urothelial cancer in the bladder, ureter, or renal pelvis that is at high risk of coming back.
  • Underwent major surgery to remove the cancer (such as radical cystectomy) within the last 120 days.
  • Currently have no signs of cancer as shown by imaging tests done within 4 weeks before starting the study.
  • Must provide a sample of the tumor tissue for analysis.
  • If you have not received prior chemotherapy with cisplatin before surgery, you must either not be eligible for or have refused cisplatin-based chemotherapy after surgery.

Exclusion Criteria

  • Had only part of the bladder or kidney removed (such as partial cystectomy or partial nephrectomy).
  • Received additional treatment like chemotherapy after surgery for bladder cancer.
  • Have an active autoimmune disease or a history of such conditions.
  • Had another active cancer within the last 3 years, except for certain localized cancers that have been treated and cured.
  • Require treatment with steroids or other drugs that suppress the immune system within 14 days before starting the study drug.
  • Tested positive for active hepatitis B or C infection.

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