Trial of Anti-PD-1 Immunotherapy and Stereotactic Radiation in Patients With Recurrent Glioblastoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pembrolizumab, Stereotactic Radiation Therapy, Surgical Resection.
- Who it may be relevant to
- Registry conditions: Glioblastoma Multiforme. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Phase Ib/II Trial of Anti-PD-1 Immunotherapy and Stereotactic Radiation in Patients With Recurrent Glioblastoma
Overview
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
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
Primary outcome measures
- 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.]
Secondary outcome measures (2)
- 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.]
- Immune action [Time frame: At baseline, prior to stereotactic radiation therapy, and prior to surgery.]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Cedars-Sinai Medical Center — Los Angeles
Identifiers
NCT: NCT04977375 · IIT2019-13-Patil-NeoPD1SRS · R21CA256421