RECRUITING

Trial of Anti-PD-1 Immunotherapy and Stereotactic Radiation in Patients With Recurrent Glioblastoma

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to assess the safety/tolerability/feasibility of pembrolizumab and radiation therapy before surgical resection in patients with recurrent glioblastoma as defined by treatment-related AEs and the number of patients who do not necessitate a delay in surgical resection, and to assess overall survival. The secondary objectives are to assess progression free survival, and to assess the T cell clonality, CD8 T cell activation and Tumor Infiltrating Lymphocyte (TIL) score after treatment

Official Title

Phase Ib/II Trial of Anti-PD-1 Immunotherapy and Stereotactic Radiation in Patients With Recurrent Glioblastoma

Quick Facts

Study Start:2021-12-09
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04977375

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 years or older
  2. * Confirmed histologic diagnosis of WHO Grade IV, Glioblastoma Multiforme
  3. * GBM recurrence or progression with planned standard of care surgical resection and repeat radiation
  4. * Tumor size less than 6 cm
  5. * ECOG performance status of 0-1
  6. * Adequate laboratory values
  1. * Contraindication to additional radiation
  2. * Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
  3. * Immunodeficiency diagnosis or receiving chronic systemic steroid therapy (exceeding 10 mg daily of prednisone) or any other form of immunosuppressive therapy
  4. * Severe hypersensitivity to pembrolizumab

Contacts and Locations

Study Contact

Clinical Trial Recruitment Navigator
CONTACT
3104232133
cancer.trial.info@cshs.org

Principal Investigator

Chirag G Patil, MD, MS
PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center

Study Locations (Sites)

Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States

Collaborators and Investigators

Sponsor: Chirag G. Patil

  • Chirag G Patil, MD, MS, PRINCIPAL_INVESTIGATOR, Cedars-Sinai Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-09
Study Completion Date2026-12

Study Record Updates

Study Start Date2021-12-09
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • Central Nervous System Tumor
  • neurosurgery
  • Brain tumor
  • spinal cord tumor
  • surgical resection
  • glioma
  • glioblastoma
  • neuropathology
  • maximal safe resection
  • CNS

Additional Relevant MeSH Terms

  • Glioblastoma Multiforme