A Canadian Phase II, Placebo-controlled Randomized Trial of Bicalutamide in Patients Receiving Maintenance Avelumab for Metastatic Urothelial Cancer.

MP-20-2024-6963

This is a Phase II, multi-center, placebo-controlled randomized controlled trial of standard of care (SOC) avelumab versus SOC avelumab with bicalutamide for patients with metastatic or locally advanced urothelial carcinoma.

2023-11-07

2024-01-31

2024-02-12

Withdrawn

Early phase I

Inclusion Criteria: 1. Age 18 or greater and able to provide informed consent for the trial; 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at screening; 3. Patients with histologically confirmed urothelial carcinoma; 4. Patients is a candidate for a course of maintenance avelumab treatment for metastatic or locally advanced urothelial carcinoma; 5. Male patients with partners of child-bearing potential must agree to 2 acceptable forms of birth control and be continued for at least 130 days after study drug is discontinued. Exclusion Criteria: 1. Patients with a history of liver disease whose hepatic enzymes, alkaline phosphatase or bilirubin are greater than twice the upper limit of normal will be ineligible. 2. Patients with neutrophils (\< 1,000/μL) will be ineligible. 3. Patients on androgen replacement therapy, or those with prostate cancer or other diseases currently treated with systemic hormonal therapy will be ineligible for study enrollment. Patients receiving 5-alpha reductase inhibitors will not be excluded. 4. Patients who have a concurrent malignancy other than UC within the past years for which treatment is planned within the next 6 months. 5. Patients taking an investigational drug within 2 weeks of enrollment into this study. 6. Patients receiving or planning to receive coumadin therapy. 7. Female patients with childbearing potential are excluded due to known teratogenic effects of bicalutamide.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

2024-02-15