A Randomized Phase III Non-Inferiority Trial, Duration of Immune Checkpoint Therapy in Locally Advanced or Metastatic Urothelial Carcinoma

February 18, 2021

Clinical Trial Information

Protocol: Alliance – A031901

SCHEMA A031901

Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.

Eligibility:

  1. Histologically or cytologically confirmed urothelial carcinoma with predominantly transitional-cell features.
  2. Locally advanced or metastatic disease prior to starting immune checkpoint blockage. TUMOR SITE: Bladder, renal, pelvis, ureter or urethra.
  3. Patients must be receiving current active treatment with standard care, FDA approved PD-1/L1 immune checkpoint inhibitor containing therapy for locally advance or metastatic.
  4. Radiographic response 12-15 months after starting  immune checkpoint inhibitor containing treatment, defined as any percent decrease in target and/or non-target lesion(s) criteria that is confirmed by repeat assessment(s) no less than 4 weeks after the criteria for response are first met without evidence of progressive disease.
  5. No toxicity from immune checkpoint inhibitor therapy that makes continuation of treatment acceptable.
  6. 18 years of age.
  7. ECOG performance status 0-2.
  8. No history of another primary malignancy except for malignancy treated with curative intent with no known active disease for more than 2 years, and adequately treated non-melanomatous skin cancer or carcinoma in situ (e.g. cervical CIS) without evidence of disease.

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