A Canadian Trial of Bicalutamide in Patients Receiving Maintenance Avelumab for Metastatic Urothelial Cancer.

NCT06018116 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: MP-20-2024-6963
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Metastatic Urothelial Carcinoma

Keywords

bicalutamide; avelumab

Outcome Measures

Primary Outcomes (1)

• Rate of bladder tumor recurrence

  The primary outcome will be to the time to investigator-assessed progression on avelumab therapy.

  30 months

Study Arms (2)

Bicalutamide

EXPERIMENTAL

standard of care (SOC) avelumab with 150mg daily oral bicalutamide

Drug: Bicalutamide 150 mg

Placebo

PLACEBO COMPARATOR

standard of care (SOC) avelumab with daily oral placebo

Drug: Placebo

Interventions

Bicalutamide 150 mg DRUG

nonsteroidal antiandrogen

Also known as: standard of care avelumab

Bicalutamide

Placebo DRUG

placebo

Also known as: standard of care avelumab

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• Female patients with childbearing potential are excluded due to known teratogenic effects of bicalutamide.

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead
• Cancer Research Society: collaborator

Study Sites (1)

CHU de Québec - Université Laval

Québec, G1G 5X1, Canada

Location

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

bicalutamide

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Paul Toren, MD, PhD, FRCSC

  CHU de Québec - Université Laval

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: August 30, 2023
• Study Start: November 7, 2023
• Primary Completion: January 31, 2024
• Study Completion: February 12, 2024
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)