Anti-Tim-3 + Anti-PD-1 + SRS for Glioblastoma

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byLawrence Kleinberg, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial studies a combination of precise radiation therapy and immune-boosting drugs to treat patients with recurring brain cancer. The goal is to directly target the tumor and enhance the body's immune response against cancer cells.

Research Team

Lawrence Kleinberg, MD

Principal Investigator

Johns Hopkins University/Sidney Kimmel Cancer Center

Eligibility Criteria

This trial is for adults over 18 with recurrent GBM who've had first-line therapy including surgery, radiation, and Temozolomide. They must have a Karnofsky Performance Status ≥ 70, no more than two recurrences of GBM or gliosarcoma confirmed by biopsy or MRI, normal organ/marrow function, and be able to undergo MRIs. Women must not be pregnant/breastfeeding and use contraception.

Inclusion Criteria

WBC ≥ 2,000/mcL absolute neutrophil count ≥ 1,500/mcL platelets ≥ 100,000/mcL hemoglobin ≥ 9.0 g/dL lymphocytes ≥ 500/mcL total bilirubin ≤ 1.5X institutional upper limit of normal AST/ALT ≤ 3.0 X institutional upper limit of normal creatinine ≤ 1.5X institutional upper limit of normal OR Creatinine clearance (CrCl) ≥ 50 mL/min (using the Cockcroft-Gault formula)

I am not pregnant or breastfeeding and have a recent negative pregnancy test.

My tumor is 5 cm or smaller.

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Exclusion Criteria

I have been treated with immune therapy, not including steroids.

I have lung disease that causes symptoms or could affect lung-related side effect management.

I have a known positive history of HIV or active Hepatitis B/C.

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Treatment Details

Interventions

MBG453 (Monoclonal Antibodies)

Trial OverviewThe trial tests the safety of stereotactic radiosurgery combined with MBG453 and spartalizumab in treating recurrent GBM. It aims to see if this combination can better target cancer cells while sparing healthy tissue compared to current treatments.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (MBG453, spartalizumab, stereotactic radiosurgery)Experimental Treatment1 Intervention

Patients receive MBG453 and spartalizumab IV over 30 minutes on Day 1. Patients then undergo stereotactic radiosurgery on Day 8. Courses with MBG453 and spartalizumab repeat every 28 days in the absence of disease progression or unacceptable toxicity.