Atezolizumab and Cabozantinib for the Treatment of Recurrent Glioblastoma

Recurrent Glioblastoma Clinical Trial

Official title: Phase I/II Study to Evaluate the Safety and Clinical Efficacy of Atezolizumab (Anti-PD-L1) in Combination With Cabozantinib in Patients With Recurrent Glioblastoma (rGBM)

Status Recruiting

Clinical Trial Summary

This phase I/II trial tests the safety and side effects of atezolizumab in combination with cabozantinib and whether they work to shrink tumors in patients with glioblastoma that has come back (recurrent). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving atezolizumab and cabozantinib may help control the disease in patients with recurrent glioblastoma.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To evaluate the safety of atezolizumab in combination with cabozantinib. (Phase I) II. To evaluate the progression-free survival at six months (PFS-6) of atezolizumab in combination with cabozantinib. (Phase II)

SECONDARY OBJECTIVE:

I. To evaluate the progression free survival (PFS), overall survival (OS), overall response rate (ORR) and duration of response of atezolizumab in combination with cabozantinib.

CORRELATIVE OBJECTIVES:

I. Profiling tumor immune cell populations (i.e., macrophage migration inhibitory factor [mIF] and immunohistochemistry [IHC] analyses of CD4, CD8, PD1, PD-L1, and PD-L2 expression).

II. Profiling of tumor, e.g., deoxyribonucleic acid (DNA), messenger (m) ribonucleic acid (RNA), microRNA and epigenetic profiling (DNA methylation), whole exome sequencing, RNA sequencing, and microRNA sequencing.

III. Peripheral blood collection for evaluation of circulating chemokines/cytokines.

IV. Stool collection for gut microbiome profiling.

OUTLINE:

Patients receive atezolizumab intravenously (IV) over 30-60 minutes on day 1 and cabozantinib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days, and then every 3 months thereafter. ;

Related Conditions & MeSH terms

• Glioblastoma
• Gliosarcoma
• Recurrence
• Recurrent Glioblastoma
• Recurrent Gliosarcoma

• NCT number: NCT05039281
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Contact: Eva Gachimova
• Phone: (713) 794-4197
• Email: egachimova@mdanderson.org
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: September 23, 2022
• Completion date: December 31, 2025