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

NCT06018116 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2024-02-15

No results posted yet for this study

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

Interventions

DRUG

Bicalutamide 150 mg

nonsteroidal antiandrogen

DRUG

Placebo

placebo

Sponsors & Collaborators

  • Cancer Research Society

    collaborator OTHER

  • CHU de Quebec-Universite Laval

    lead OTHER

Principal Investigators

  • Paul Toren, MD, PhD, FRCSC · CHU de Québec - Université Laval

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-07
Primary Completion
2024-01-31
Completion
2024-02-12
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06018116 on ClinicalTrials.gov