Recruiting
Phase 1
Phase 2

Pembrolizumab & Radiation Therapy

Sponsor:

Chirag G. Patil

Code:

NCT04977375

Conditions

Glioblastoma Multiforme

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pembrolizumab

Stereotactic Radiation Therapy

Surgical Resection

Study Details

Brief summary:

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

Conditions

Glioblastoma Multiforme

Study ID

NCT04977375

Start date

Dec 9, 2021

Status verified date

Aug, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 18 years or older
  • Confirmed histologic diagnosis of WHO Grade IV, Glioblastoma Multiforme
  • GBM recurrence or progression with planned standard of care surgical resection and repeat radiation
  • Tumor size less than 6 cm
  • ECOG performance status of 0-1
  • Adequate laboratory values

Exclusion Criteria:

  • Contraindication to additional radiation
  • 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
  • Immunodeficiency diagnosis or receiving chronic systemic steroid therapy (exceeding 10 mg daily of prednisone) or any other form of immunosuppressive therapy
  • Severe hypersensitivity to pembrolizumab

Complete inclusion/exclusion criteria are detailed in the protocol.

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pembrolizumab with stereotactic radiation therapy and surgical resection

Interventions

Pembrolizumab

Pembrolizumab 400mg administered intravenously on Day 1, and then beginning 6 weeks post-surgery, subjects will receive 400 mg pembrolizumab every 6 weeks

Stereotactic Radiation Therapy

Standard of care stereotactic radiation of 24 grays over 3 days, administered beginning on Day 7

Surgical Resection

Standard of care surgical resection of tumor on Day 10-28

Primary outcome measure

  • Safety and tolerability measured by the incidence of adverse events, serious adverse events and grade 3 or above treatment related adverse events. [ Time Frame: From start of study treatment until confirmation of disease progression, intolerable toxicities, withdrawal of consent. Assessed up to 2 years. ]
  • Overall survival [ Time Frame: From start of study treatment until death, loss to follow-up, or withdrawal of consent. Assessed up to 2 years. ]

Central Contacts and Locations

Central contacts

Clinical Trial Recruitment Navigator

3104232133cancer.trial.info@cshs.org

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Clinical Trial Recruitment Navigator

310-423-2133cancer.trial.info@cshs.org

Principal Investigator:

Stephen Shiao, MD, PhD

More Information

Sponsor

Chirag G. Patil

Last update posted

Sep 3, 2025

Last verified

Aug, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Chirag G. Patil on 2025-09-03.