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Checkpoint Inhibitor

Radiation Therapy + Durvalumab ± Tremelimumab for Bladder Cancer

Phase 2

Waitlist Available

Led By Albert Chang

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

Patients must be ineligible for or refuse cisplatin-based chemotherapy. Cisplatin ineligibility is defined as meeting 1 of the following criteria: Creatinine clearance (calculated or measured) < 60 mL/min, Common Terminology Criteria for Adverse Events (CTCAE) grade >= 2 audiometric hearing loss, CTCAE grade 2 or higher peripheral neuropathy, New York Heart Association class III heart failure, Any other criteria deemed by the investigator to make the patient unsuitable for cisplatin-based chemotherapy. Note: The reason for cisplatin ineligibility must be documented. Patients may refuse cisplatin-based chemotherapy after an informed discussion of the risks and benefits, and the reason for refusal must be documented.

Serum creatinine clearance (CL) > 30 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance.

Must not have

History of autoimmune disease, including, but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegner?s granulomatosis, Sjogren?s syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any subject known to have evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing radiation therapy with or without two different drugs to treat bladder cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include immune-related reactions affecting organs, fatigue, infusion reactions similar to allergic responses, digestive issues such as colitis, skin rashes, hormonal imbalances like thyroid disorders, and an increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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I cannot or choose not to receive cisplatin-based chemotherapy due to health reasons or personal choice.

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My kidney function, measured by creatinine clearance, is good.

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I have a tumor that can be measured and has not been treated with radiation.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of autoimmune disease.

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

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I have limited self-care and spend more than half of my waking hours in bed or a chair.

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I haven't had major surgery in the last 28 days, except for a biopsy or specific bladder tumor removal.

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I have had surgery or radiation therapy for bladder cancer.

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I have a history of specific lung conditions or signs of lung inflammation on a CT scan.

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I have had radiation therapy to my abdomen or pelvis area before.

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I have had cancer spread to the lining of my brain and spinal cord.

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I have seizures that are not controlled by medication.

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I am allergic to durvalumab and tremelimumab.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events assessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.03 criteria (Safety lead-in cohort)

Progression- free survival (PFS) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 (Expansion cohort)

Secondary study objectives

Abscopal response (in patients with metastatic disease) determined by RECIST v 1.1 with response (PR and CR) sites away from the primary irradiated tumor

Disease-specific survival

Duration of response

+5 more

Other study objectives

Change in circulating and tumor-infiltrating T-cell receptor (TCR) repertoire

Circulating immune cell subsets assessed via flow cytometry in peripheral blood mononuclear cell

Gene signature biomarker

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Regimen B (radiation therapy, durvalumab, tremelimumab)Experimental Treatment3 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 Treatment2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tremelimumab

2017

Completed Phase 2

~3070

External Beam Radiation Therapy

2006

Completed Phase 3

~3300