Study on Anti-PD-1 Immunotherapy and Targeted Radiation for Patients with Recurrent Glioblastoma

Sponsor: Chirag G. Patil

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04977375

Provider View

This clinical trial is testing the safety and feasibility of using pembrolizumab, an immunotherapy drug, along with targeted radiation before surgery in patients with recurrent glioblastoma, a type of brain cancer. The study also aims to evaluate overall survival and other immune responses.

Patient Parameters

Program Overview

The goal of this study is to determine if combining pembrolizumab, an immunotherapy drug, with targeted radiation therapy before surgery is safe and feasible for patients with recurrent glioblastoma, a type of aggressive brain cancer. Researchers will monitor for any treatment-related side effects and check if the treatment can be completed without delaying surgery. The study will also look at how long patients live after treatment, how long they remain free from cancer progression, and how their immune system responds to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Be 18 years or older.
  • Have a confirmed diagnosis of Grade IV Glioblastoma Multiforme, a type of brain cancer.
  • Have a recurrence or progression of glioblastoma with plans for standard surgical removal and additional radiation.
  • Tumor size must be less than 6 cm.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate blood test results showing good organ function.

Exclusion Criteria

  • Cannot have conditions that prevent additional radiation treatment.
  • Cannot have previously received treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or similar immune therapies.
  • Cannot have an immune system deficiency or be on long-term steroid therapy exceeding 10 mg of prednisone daily, or other immunosuppressive treatments.
  • Cannot have severe allergic reactions to pembrolizumab.

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