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NCT Number: NCT04977375

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location status: Recruiting

Location contact

Adam Mamelak, MD

SUB_INVESTIGATOR

Amin Mirhadi, MD

SUB_INVESTIGATOR

Behrooz Hakimian, MD

SUB_INVESTIGATOR

Clinical Trial Recruitment Navigator

CONTACT

[email protected]

310-423-2133

Jeremy Rudnick, MD

SUB_INVESTIGATOR

Jethro Hu, MD

SUB_INVESTIGATOR

John Yu, MD

SUB_INVESTIGATOR

Keith Black, MD

SUB_INVESTIGATOR

Ray Chu, MD

SUB_INVESTIGATOR

Stephen Shiao, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Stereotactic radiation therapy

Radiation

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

Surgical resection

Procedure

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

Primary outcomes

  1. 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.

    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.

  2. Overall survival

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

    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.

Secondary outcomes

  1. Progression free survival

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

    From start of study treatment until confirmation of disease progression (per iRANO Criteria), intolerable toxicities, withdrawal of consent, or up to 2 years or 18 cycles of pembrolizumab, whichever comes first.

  2. Immune action

    Time frame: At baseline, prior to stereotactic radiation therapy, and prior to surgery.

    To assess the T cell clonality, CD8 T cell activation and Tumor Infiltrating Lymphocyte (TIL) score after treatment. Blood draws for research purposes performed after obtaining consent but prior to neoadjuvant pembrolizumab administration, and at the time of initiation of SRT and at the time of surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trial Recruitment Navigator

CONTACT

[email protected]

3104232133

Sponsors and collaborators

Lead sponsor

Chirag G. Patil

Other

Collaborators

  • Merck Sharp & Dohme LLC
  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Jul 26, 2021
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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