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Bicalutamide + Avelumab for Bladder Cancer (CANUCK-01 Trial)

Phase 2

Waitlist Available

Research Sponsored by CHU de Quebec-Universite Laval

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 months

Awards & highlights

CANUCK-01 Trial Summary

This trial tests a new drug combo to treat advanced bladder cancer.

Who is the study for?

This trial is for adults with advanced urothelial carcinoma who can consent to treatment and have a performance status of 0-2, indicating they are fully active or limited in physical activity. They must be candidates for maintenance avelumab therapy and agree to effective birth control if applicable. Excluded are those with low neutrophils, significant liver disease, on hormonal therapies (except 5-alpha reductase inhibitors), females of childbearing potential, concurrent malignancy within 5 years, recent investigational drug use or planned coumadin therapy.Check my eligibility

What is being tested?

The study compares standard care using the immunotherapy drug avelumab alone versus combining it with bicalutamide (a hormone blocker) in patients with metastatic or locally advanced urothelial cancer. Participants will be randomly assigned to receive either the combination treatment or a placebo alongside their regular avelumab regimen.See study design

What are the potential side effects?

Possible side effects include immune-related reactions due to avelumab such as skin issues, colitis, hepatitis; fatigue; infusion reactions; and hormonal effects from bicalutamide like breast swelling/tenderness and hot flashes. Bicalutamide may also cause birth defects if partners become pregnant.

CANUCK-01 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years or older and can give my consent.

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I can take care of myself and am up and about more than half of my waking hours.

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I have been diagnosed with urothelial carcinoma.

CANUCK-01 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of bladder tumor recurrence

CANUCK-01 Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BicalutamideExperimental Treatment1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

standard of care (SOC) avelumab with daily oral placebo

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

CHU de Quebec-Universite LavalLead Sponsor

167 Previous Clinical Trials

107,157 Total Patients Enrolled

Cancer Research SocietyUNKNOWN

1 Previous Clinical Trials

40 Total Patients Enrolled

Paul Toren, MD, PhD, FRCSCStudy ChairCHU de Québec - Université Laval

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent can Bicalutamide put someone in harm's way?

"Our team here at Power deems Bicalutamide to be moderately safe, awarding it a score of 2. This is because while there are some safety data available from Phase 2 trials, efficacy has yet to be studied in depth."

Answered by AI

Is enrollment still available for this clinical investigation?

"Evidenced by clinicaltrials.gov, the recruitment period for this medical trial has passed. The study was initially posted on October 1st 2023 and edited for a final time on September 6th 2023. Notwithstanding, there are still 173 other trials actively searching for patients to join their research teams."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Canadian Trial of Bicalutamide in Patients Receiving Maintenance Avelumab for Metastatic Urothelial Cancer.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06018116.