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

Palo Alto (17 mi)

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.

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

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

My tumor is 5 cm or smaller.

I am able to care for myself but may not be able to do active work.

I've had surgery, radiation, and Temozolomide for my cancer, unless my tumor is MGMT unmethylated.

I am 18 years old or older.

I have been diagnosed with Grade IV brain cancer.

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.

I have had an organ or stem cell transplant.

My cancer has spread outside of my brain.

I've been taking more than 4 mg of dexamethasone or similar medication daily for at least 5 days.

Treatment Details

The 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.

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.