Combination Therapy + Radiation for Glioblastoma

Recruiting in Palo Alto (17 mi)

+3 other locations

Jian L. Campian, M.D., Ph.D. - Doctors ...

Overseen byJian Campian, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Washington University School of Medicine

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing a combination of treatments including a new drug, radiation therapy, and other medications for patients with aggressive brain cancer that has returned. The goal is to boost the body's immune system to better fight the cancer, shrink tumors, and help patients live longer.

Eligibility Criteria

This trial is for adults with recurrent grade 4 glioblastoma or gliosarcoma who have measurable disease, normal organ and bone marrow function, and a Karnofsky performance status ≥ 60%. Patients must not be on high doses of steroids or have active infections, uncontrolled HIV/hepatitis B/C, certain heart conditions, autoimmune diseases requiring systemic treatment in the past 2 years (except under specific conditions), or a history of allergic reactions to similar drugs.

Inclusion Criteria

My brain tumor is a high-grade glioblastoma or gliosarcoma.

I have used bevacizumab temporarily for brain swelling or tissue damage.

Prior use of the Optune device is allowed without a washout period

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Exclusion Criteria

I am receiving treatment for an autoimmune disease.

Any history of serotonin syndrome after receiving serotonergic drugs

I do not have uncontrolled HIV or active hepatitis B or C.

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Treatment Details

Interventions

Bevacizumab (Angiogenesis Inhibitor)
Epacadostat (IDO1 Inhibitor)
Radiation therapy (Radiation)
Retifanlimab (Immune Checkpoint Inhibitor)

Trial OverviewThe study tests combining retifanlimab with radiation therapy and bevacizumab with/without epacadostat in treating recurrent brain tumors. It aims to enhance anti-tumor immune response and improve survival by leveraging the synergy between radiation therapy and immune modulators.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Regimen B: Retifanlimab+RT+bevacizumab+epacadostatExperimental Treatment5 Interventions

* Retifanlimab will be given intravenously over the course of 30 to 60 minutes at a dose of 500 mg on Day 1 of each 28-day cycle. * Bevacizumab will be given intravenously at a dose of 10 mg/kg on Days 1 and 15 of each 28-day cycle. * Ten fractions of radiation therapy will be given at a dose of 3.5 Gy per fraction * Retifanlimab and bevacizumab will be started approximately two weeks before the first day of radiation therapy * Epacadostat will be administered orally at 400 mg BID. * Treatment may continue for up to two years.

Group II: Regimen A: Retifanlimab+RT+bevacizumabExperimental Treatment4 Interventions

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

🇪🇺 Approved in European Union as Avastin for: