A Canadian Trial of Bicalutamide in Patients Receiving Maintenance Avelumab for Metastatic Urothelial Cancer.
Reason given: Results of EV302 study do not make it feasible to complete a study in second line avelumab immunotherapy. The new standard of care make this study not pertinent.
Key facts
- Where
- Québec, CanadaSee the site
- Phase
- Phase 2
Where in Canada
- CHU de Quebec-Universite LavalQuébec, CanadaNo longer taking part
Trial details
- Who runs it
- CHU de Quebec-Universite Laval
- Trial code
- NCT06018116
- Record updated
- 15 February 2024
- Original description
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.Read full original descriptionShow less
A Canadian Phase II, Placebo-controlled Randomized Trial of Bicalutamide in Patients Receiving Maintenance Avelumab for Metastatic Urothelial Cancer.
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.
Inclusion: Age 18 or greater and able to provide informed consent for the trial; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at screening; Patients with histologically confirmed urothelial carcinoma; Patients is a candidate for a course of maintenance avelumab treatment for metastatic or locally advanced urothelial carcinoma; 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: 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; Patients who have a concurrent malignancy other than UC within the past years for which treatment is planned within the next 6 months; Patients taking an investigational drug within 2 weeks of enrollment into this study; Patients receiving or planning to receive coumadin therapy; 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; Patients with neutrophils (< 1,000/μL) will be ineligible; Female patients with childbearing potential are excluded due to known teratogenic effects of bicalutamide.