NCT02337686

Pembrolizumab in Treating Patients With Recurrent Glioblastoma

Pharmacodynamic Study of Pembrolizumab in Patients With Recurrent Glioblastoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies the effects of pembrolizumab on the body, or pharmacodynamics, in patients with glioblastoma that has come back. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate immune effector function in resected glioblastoma tissue after treatment with intravenously administered pembrolizumab monotherapy in the neoadjuvant setting in patients with recurrent glioblastoma. II. To correlate the progression free survival at 6 months (PFS6) with objective increases in the immune effector T cell: regulatory T cell (Treg) ratio in tumor tissue as measured by ex vivo T-cell-specific cytokines profiling. SECONDARY OBJECTIVES: I. Comparison of time to progression of last prior therapy to time to progression on pembrolizumab, median duration of response, overall response rate (ORR), and overall survival (OS) and safety. TERTIARY OBJECTIVES: I. To identify imaging characteristics associated with immunological changes in tumor following treatment with pembrolizumab. OUTLINE: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day -21 and day -1, and then undergo surgery on day 0. After 2-3 weeks or recovery from surgery, patients continue to receive pembrolizumab IV over 30 minutes every 3 weeks. Courses repeat every 42 days for up to 24 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months.

Conditions

• Recurrent Glioblastoma
• Recurrent Gliosarcoma

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
BIOLOGICAL	Pembrolizumab	Given IV
OTHER	Pharmacological Study	Correlative studies
PROCEDURE	Therapeutic Conventional Surgery	Undergo surgery

Timeline

• Start date: 2015-04-28
• Primary completion: 2017-05-24
• Completion: 2026-12-31
• First posted: 2015-01-14
• Last updated: 2025-08-15
• Results posted: 2023-01-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study