NCT03961971

Trial of Anti-Tim-3 in Combination With Anti-PD-1 and SRS in Recurrent GBM

A Phase I Trial of Anti-Tim-3 in Combination With Anti-PD-1 and SRS in Recurrent GBM

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects of stereotactic radiosurgery with MBG453 and spartalizumab in treating patients with recurrent glioblastoma multiforme (GBM). Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor to more precisely target the cancer. Monoclonal antibodies, such as MBG453 and spartalizumab may interfere with the ability of tumor cells to grow and spread. Giving stereotactic radiosurgery together with immunotherapy may be a better treatment for GBM.

Detailed description

Primary Objectives To determine safety of MBG453 given in combination with spartalizumab and SRS in patients with recurrent GBM. Secondary Objectives To assess the preliminary anti-tumor activity using the following measures: 1. To estimate overall survival 2. To estimate progression-free survival 3. To estimate Radiographic Response (RANO and iRANO) 4. To evaluate pain for patients undergoing the treatment of anti-TIM3 and anti-PD1 in combination with SRS Exploratory Objectives 1. To assess the effects of MGB453, spartalizumab and their combination with SRS on immune cells in peripheral blood, including but not limited to the T cell compartments, myeloid cells, and serum proteins (cytokines and other immune modulators). 2. To assess the pharmacodynamic activity in tumor tissue and peripheral blood in treated subjects who undergo tumor biopsies as clinically indicated. 3. To explore potential associations between biomarker measures and anti-tumor activity by analyzing markers of inflammation, immune activation, host tumor growth factors, and tumor-derived proteins in the pre-treatment and on-treatment setting. 4. To explore characteristics of tumor immune microenvironment change after the treatment. OUTLINE: Patients receive MBG453 and spartalizumab intravenously (IV) over 30 minutes each on Day 1. Patients then undergo stereotactic radiosurgery on Day 8 per standard of care. Courses with MBG453 and spartalizumab repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months thereafter.

Conditions

• Glioblastoma Multiforme

Interventions

Type	Name	Description
DRUG	MBG453	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.

Timeline

• Start date: 2020-02-18
• Primary completion: 2022-11-16
• Completion: 2026-09-01
• First posted: 2019-05-23
• Last updated: 2025-09-10

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study