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
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:
- Histologically or cytologically confirmed urothelial carcinoma (UC) with predominantly transitional-cell features. Locally advanced or metastatic disease prior to starting immune checkpoint blockade.
- 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.
- No current immunosuppressive medication exceeding 10mg/day of prednisone or its equivalent.
- 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:
- 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.
- At least 18 years of age.
- ECOG Performance Status 0-2.