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

NCT04977375 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: IIT2019-13-Patil-NeoPD1SRSR21CA256421
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability measured by the incidence of adverse events, serious adverse events and grade 3 or above treatment related adverse events.

  Safety and tolerability measured by the incidence of adverse events, serious adverse events and grade 3 or above treatment related adverse events as assessed per CTCAE, Version 5.0.

  From start of study treatment until confirmation of disease progression, intolerable toxicities, withdrawal of consent. Assessed up to 2 years.

• Overall survival

  From start of study treatment until death, loss to follow-up, or withdrawal of consent. Subjects who are lost to survival follow-up will not be replaced, and public records may be accessed to assess Overall Survival.

  From start of study treatment until death, loss to follow-up, or withdrawal of consent. Assessed up to 2 years.

Secondary Outcomes (2)

• Progression free survival

  From start of study treatment until until confirmation of disease progression, intolerable toxicities, withdrawal of consent. Assessed up to 2 years.

• Immune action

  At baseline, prior to stereotactic radiation therapy, and prior to surgery.

Study Arms (1)

Pembrolizumab with stereotactic radiation therapy and surgical resection

EXPERIMENTAL

Drug: Pembrolizumab; Radiation: Stereotactic Radiation Therapy; Procedure: Surgical Resection

Interventions

Pembrolizumab DRUG

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

Pembrolizumab with stereotactic radiation therapy and surgical resection

Stereotactic Radiation Therapy RADIATION

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

Pembrolizumab with stereotactic radiation therapy and surgical resection

Surgical Resection PROCEDURE

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

Pembrolizumab with stereotactic radiation therapy and surgical resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chirag G. Patil: lead
• Merck Sharp & Dohme LLC: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

MeSH Terms

Conditions

Glioblastoma; Central Nervous System Neoplasms; Brain Neoplasms; Spinal Cord Neoplasms; Glioma

Interventions

pembrolizumab; Radiosurgery

Condition Hierarchy (Ancestors)

Astrocytoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases; Spinal Cord Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Chirag G Patil, MD, MS

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trial Recruitment Navigator

CONTACT

3104232133; cancer.trial.info@cshs.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Neurosurgery Program Director, Neurosurgery Residency Training

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: July 26, 2021
• Study Start: December 9, 2021
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)