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

February 18, 2021

Protocol: Alliance – A031901

SCHEMA A031901

Please Note: Below is a partial list of eligibility, please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 or (810) 762-8038 for full eligibility requirements.

Eligibility:

Pre-Registration: 

  1. Histologically or cytologically confirmed urothelial carcinoma (UC) with predominantly transitional-cell features. Locally advanced or metastatic disease prior to starting immune checkpoint blockade.
  2. Patients must have received at least one cycle of current active treatment with standard of care (SOC) FDA approved PD-1/L1 immune checkpoint inhibitor (ICI)-containing therapy for locally advance or metastatic UC.
  3. No current immunosuppressive medication exceeding 10mg/day of prednisone or its equivalent.
  4. No history of another primary malignancy except for malignancy treated with curative intent with no known active disease for ≥ 2 years, and adequately treated nonmelanomatous skin cancer or carcinoma in situ (e.g. cervical CIS) without evidence of disease.

Registration:

  1. Patients without progressive disease per RECIST v 1.1 guidelines (i.e., with an ongoing CR, PR or SD) following completion of 12-15 months of ICI treatment.
  2. At least 18 years of age.
  3. ECOG Performance Status 0-2.

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