Radiation Therapy + Durvalumab ± Tremelimumab for Bladder Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Albert Chang, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Jonsson Comprehensive Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase II trial studies the side effects and how well radiation therapy and durvalumab with or without tremelimumab work in treating participants with bladder cancer that cannot be removed by surgery, has spread to nearby tissue or lymph nodes, or that has spread to other parts of the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Monoclonal antibodies, such as durvalumab and tremelimumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving radiation therapy and durvalumab with or without tremelimumab will work better in treating participants with bladder cancer.

Research Team

Albert Chang, MD

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Eligibility Criteria

This trial is for adults with bladder cancer that can't be surgically removed, has spread locally or to other body parts. They should have a life expectancy of at least 12 weeks and cannot take cisplatin-based chemotherapy. Participants must not have had certain treatments before, like immunosuppressants or abdominal radiation, and women must not be pregnant.

Inclusion Criteria

Your bilirubin levels in the blood should not be higher than 1.5 times the normal limit, unless you have a specific condition called Gilbert's syndrome, in which case you can still participate after talking to your doctor.

My liver function tests are within the required range.

Your platelet count is at least 100,000 per cubic millimeter.

Exclusion Criteria

I have a history of autoimmune disease.

Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).

I do not have any serious ongoing illnesses that my doctor is not able to control.

Treatment Details

Interventions

• Durvalumab (Checkpoint Inhibitor)
• External Beam Radiation Therapy (Radiation)
• Tremelimumab (Checkpoint Inhibitor)

Trial Overview The study tests the effectiveness of radiation therapy combined with durvalumab (a monoclonal antibody) alone or alongside tremelimumab in treating advanced bladder cancer. The goal is to see if adding tremelimumab improves outcomes compared to just durvalumab and radiation.

Participant Groups

Group I: Regimen B (radiation therapy, durvalumab, tremelimumab) Experimental Treatment 3 Interventions

Participants receive tremelimumab IV over 60 minutes on day 1 for up to 2 courses and durvalumab IV over 60 minutes on day 1. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression of unacceptable toxicity. Participants also receive undergo EBRT for 5 fractions beginning on day 8 of course 1.

Group II: Regimen A (radiation therapy and durvalumab) Experimental Treatment 2 Interventions

Participants receive durvalumab IV over 60 minutes on day 1. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity. Participants also undergo EBRT for 5 fractions beginning on day 8 of course 1.

Durvalumab is already approved in Japan for the following indications:

Approved in Japan as Imfinzi for:

• Not specified in provided sources

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

Dr. Aparna Bhaduri

Jonsson Comprehensive Cancer Center

Chief Medical Officer since 2024

MD

Dr. Michael A. Teitell

Jonsson Comprehensive Cancer Center

Chief Executive Officer since 2024

MD, PhD

AstraZeneca

Industry 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