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

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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04977375
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Chirag G. Patil
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Chirag G Patil, MD, MS
Principal Investigator Affiliation	Cedars-Sinai Medical Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry, NIH
Overall Status	Active, not recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma Multiforme

Arms & Interventions

Arms

Experimental: Pembrolizumab with stereotactic radiation therapy and surgical resection

Interventions

Drug: - Pembrolizumab

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

Radiation: - Stereotactic Radiation Therapy

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

Procedure: - Surgical Resection

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Cedars-Sinai Medical Center, Los Angeles, California

Status

Address

Cedars-Sinai Medical Center

Los Angeles, California, 90048