Durvalumab + BCG for Bladder Cancer

(POTOMAC Trial)

Recruiting in Palo Alto (17 mi)

+110 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing a new treatment that combines two therapies to help the immune system fight bladder cancer. It targets patients whose cancer has not spread into the muscle layer of the bladder. The treatment works by helping the body's defense system recognize and destroy cancer cells more effectively.

Research Team

Eligibility Criteria

This trial is for adults with high-risk non-muscle-invasive bladder cancer who haven't had immune therapy or BCG for bladder cancer, and no recent immunosuppressants. It's not for those with muscle-invasive or advanced cancer, certain autoimmune diseases, or a history of other cancers (with some exceptions).

Inclusion Criteria

I am 18 years old or older.

My bladder cancer is high-risk but hasn't spread beyond the inner layers.

I had surgery to remove bladder cancer not more than 4 months ago, and all visible cancer was removed.

Exclusion Criteria

I am not on cancer treatment but can take hormones for other conditions.

I have an autoimmune or inflammatory disorder but it's controlled or I've been stable for the last 5 years.

I had cancer before, but it's either been treated, is low risk, or hasn't come back in over 2 years.

Treatment Details

Interventions

• Bacillus Calmette-Guerin (BCG) (Cancer Vaccine)
• Durvalumab (PD-L1 Inhibitor)

Trial Overview The study tests Durvalumab combined with BCG against standard BCG treatment alone in patients with bladder cancer that hasn't invaded the muscle layer. The goal is to see if adding Durvalumab improves outcomes.

Participant Groups

Group I: Durvalumab plus BCG (induction only) Experimental Treatment 2 Interventions

Durvalumab (MEDI4736) plus Bacillus Calmette-Guerrin (BCG) combination therapy

Group II: Durvalumab plus BCG (induction + maintenance) Experimental Treatment 2 Interventions

Durvalumab (MEDI4736) plus Bacillus Calmette-Guerrin (BCG) combination therapy

Group III: BCG treatment (Standard of care therapy) Active Control 1 Intervention

Bacillus Calmette-Guerrin (BCG) standard of care treatment

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology