Clinical trial · Interventional
A Canadian Trial of Bicalutamide in Patients Receiving Maintenance Avelumab for Metastatic Urothelial Cancer.
A Canadian Phase II, Placebo-controlled Randomized Trial of Bicalutamide in Patients Receiving Maintenance Avelumab for Metastatic Urothelial Cancer.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 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.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Urothelial Carcinoma | Urothelial Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bicalutamide 150 mg | Drug | Bicalutamide | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Bicalutamide
- description
- standard of care (SOC) avelumab with 150mg daily oral bicalutamide
- interventionNames
- Drug: Bicalutamide 150 mg
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- standard of care (SOC) avelumab with daily oral placebo
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Rate of bladder tumor recurrence
- timeFrame
- 30 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available