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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Chirag G. Patil
Study ID
NCT04977375
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Glioblastoma Multiforme

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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
  • 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

Study Details

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

Key Dates

Start date
Dec 9, 2021
Status verified
Aug 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab with stereotactic radiation therapy and surgical resection

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Clinical Trial Recruitment Navigator
[email protected]
310-423-2133
Stephen Shiao, MD, PhD (PRINCIPAL_INVESTIGATOR)
Jethro Hu, MD (SUB_INVESTIGATOR)
Jeremy Rudnick, MD (SUB_INVESTIGATOR)
Keith Black, MD (SUB_INVESTIGATOR)
Ray Chu, MD (SUB_INVESTIGATOR)
John Yu, MD (SUB_INVESTIGATOR)
Adam Mamelak, MD (SUB_INVESTIGATOR)
Amin Mirhadi, MD (SUB_INVESTIGATOR)
Behrooz Hakimian, MD (SUB_INVESTIGATOR)

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By research site
Cedars-Sinai Medical Center· Los Angeles, CA

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