Pembrolizumab with focused stereotactic radiation before surgery for recurrent glioblastoma
Phase Ib/II Trial of Anti-PD-1 Immunotherapy and Stereotactic Radiation in Patients With Recurrent Glioblastoma
This trial will test whether giving pembrolizumab plus focused radiation before planned surgery is safe and helps adults with recurrent glioblastoma live longer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cedars-Sinai Medical Center Academic / other |
| Drugs / interventions | pembrolizumab, radiation, prednisone |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT04977375 on ClinicalTrials.gov |
What this trial studies
This Phase 1/2, single-center trial gives pembrolizumab (an anti-PD-1 antibody) together with stereotactic radiation prior to planned surgical resection in adults with recurrent glioblastoma. The primary goals are to test safety, tolerability, and feasibility measured by treatment-related adverse events and the number of patients who can proceed to surgery without delay, with overall survival as a key outcome. Secondary endpoints include progression-free survival and immune correlative studies such as T-cell clonality, CD8 T-cell activation, and tumor-infiltrating lymphocyte scoring. Key eligibility features include age ≥18, ECOG 0–1, tumor <6 cm, no prior anti-PD-1/PD-L1 therapy, and the ability to tolerate additional radiation; the trial is conducted at Cedars-Sinai Medical Center in Los Angeles.
Who should consider this trial
Good fit: Ideal candidates are adults with recurrent WHO grade IV glioblastoma who are scheduled for repeat surgical resection, have tumors under 6 cm, an ECOG performance status of 0–1, adequate labs, and no prior PD-1/PD-L1 therapy.
Not a fit: Patients who cannot receive additional radiation, who previously received anti-PD-1/PD-L1 therapy, who have immune deficiency or require chronic high-dose steroids, or who have severe hypersensitivity to pembrolizumab are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could boost anti-tumor immune responses around the time of surgery and potentially prolong survival for people with recurrent glioblastoma.
How similar studies have performed: Early studies combining checkpoint blockade and radiation have shown encouraging immune effects but mixed clinical outcomes in glioblastoma, so this preoperative combination remains promising but not yet proven.
Eligibility criteria
Show full 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.
Where this trial is running
Los Angeles, California
- Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Chirag G Patil, MD, MS — Cedars-Sinai Medical Center
- Study coordinator: Clinical Trial Recruitment Navigator
- Email: cancer.trial.info@cshs.org
- Phone: 3104232133
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.