13 Participants Needed

Radiation Therapy + Durvalumab ± Tremelimumab for Bladder Cancer

Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Jonsson Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot take any other systemic chemotherapy, biologic, or hormonal therapy for cancer treatment while participating in the trial. If you have been on prior systemic therapies, a washout period (time without taking certain medications) of at least 45 days is required.

Is the combination of Durvalumab and Tremelimumab safe for humans?

The combination of Durvalumab and Tremelimumab has been studied in various cancers and generally shows a tolerable safety profile, though it can lead to significant side effects. In one study, 63.6% of patients experienced severe side effects, such as neutropenia (low white blood cell count), and some experienced serious adverse events, but these were mostly related to chemotherapy rather than the combination itself.12345

What makes the treatment of Radiation Therapy + Durvalumab ± Tremelimumab for bladder cancer unique?

This treatment is unique because it combines radiation therapy with durvalumab, an immune-boosting drug that blocks a protein (PD-L1) to help the body's immune system attack cancer cells, and tremelimumab, which targets another protein (CTLA-4) to further enhance the immune response. This combination aims to improve outcomes for bladder cancer patients who have limited treatment options, especially those who cannot undergo standard chemotherapy.26789

What data supports the effectiveness of the drug Durvalumab in combination with Tremelimumab for treating bladder cancer?

Durvalumab has been approved for treating advanced bladder cancer after chemotherapy, and studies show that combining it with Tremelimumab can enhance immune responses against cancer. Additionally, in lung cancer, this combination has improved survival rates, suggesting potential benefits for bladder cancer as well.127910

Who Is on the Research Team?

AC

Albert Chang, MD

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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.
See 13 more

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.
See 24 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive durvalumab with or without tremelimumab and undergo radiation therapy. Durvalumab is administered every 28 days for up to 13 courses, and radiation therapy is given for 5 fractions starting on day 8 of course 1.

Up to 13 months

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, with follow-up visits at 8 weeks, then every 12 and 16 weeks.

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

  • Durvalumab
  • External Beam Radiation Therapy
  • Tremelimumab
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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Regimen B (radiation therapy, durvalumab, tremelimumab)Experimental Treatment3 Interventions
Group II: Regimen A (radiation therapy and durvalumab)Experimental Treatment2 Interventions

Durvalumab is already approved in European Union, United States, Japan for the following indications:

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Approved in European Union as Imfinzi for:
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Approved in United States as Imfinzi for:
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Approved in Japan as Imfinzi for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials
373
Recruited
35,200+

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

Published Research Related to This Trial

Durvalumab is an FDA-approved monoclonal antibody that enhances T-cell responses against cancer by blocking the PD-L1 pathway, specifically for patients with advanced urothelial carcinoma who have progressed after platinum-based chemotherapy.
The drug is currently being tested in phase III trials for various cancers, including lung and head and neck cancers, indicating its potential broad application in oncology beyond urothelial carcinoma.
Durvalumab: First Global Approval.Syed, YY.[2022]
The combination of durvalumab and tremelimumab was studied in 19 articles involving 2052 patients with solid tumors, showing some benefits over traditional chemotherapy in certain tumor types.
However, this combination did not consistently outperform durvalumab alone, indicating that while it may have potential, further research with larger and better-designed studies is needed to clarify its efficacy.
Durvalumab Plus Tremelimumab in Solid Tumors: A Systematic Review.Arru, C., De Miglio, MR., Cossu, A., et al.[2023]
The combination of durvalumab and tremelimumab in cancer treatment is associated with a higher incidence of severe adverse events (32.6%) compared to durvalumab alone (23.8%), indicating increased safety concerns with the combination therapy.
Patients receiving the combination therapy also experienced higher rates of specific side effects such as diarrhea (15.6% vs. 8.1%), rash (11.1% vs. 6.5%), and treatment discontinuation (18% vs. 3%), highlighting the need for careful monitoring and patient counseling regarding these risks.
Adverse Events and Tolerability of Combined Durvalumab and Tremelimumab versus Durvalumab Alone in Solid Cancers: A Systematic Review and Meta-Analysis.Fahmy, O., Ahmed, OAA., Khairul-Asri, MG., et al.[2023]

Citations

Durvalumab: First Global Approval. [2022]
Durvalumab Plus Tremelimumab in Solid Tumors: A Systematic Review. [2023]
Adverse Events and Tolerability of Combined Durvalumab and Tremelimumab versus Durvalumab Alone in Solid Cancers: A Systematic Review and Meta-Analysis. [2023]
Patient-reported outcomes with durvalumab, with or without tremelimumab, plus chemotherapy as first-line treatment for metastatic non-small-cell lung cancer (POSEIDON). [2023]
DUART: durvalumab after radiotherapy in patients with unresectable, stage III NSCLC who are ineligible for chemotherapy. [2022]
Safety of FOLFIRI + Durvalumab +/- Tremelimumab in Second Line of Patients with Advanced Gastric Cancer: A Safety Run-In from the Randomized Phase II Study DURIGAST PRODIGE 59. [2022]
Durvalumab and tremelimumab combination therapy versus durvalumab or tremelimumab monotherapy for patients with solid tumors: A systematic review and meta-analysis. [2022]
Tremelimumab: First Approval. [2023]
Phase I Study of Tremelimumab Monotherapy or in Combination With Durvalumab in Japanese Patients With Advanced Solid Tumors or Malignant Mesothelioma. [2022]
Concurrent durvalumab and radiation therapy (DUART) followed by adjuvant durvalumab in patients with localized urothelial cancer of bladder: results from phase II study, BTCRC-GU15-023. [2023]
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