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

Who is this study for? Patients with Glioblastoma
What treatments are being studied? Pembrolizumab+Stereotactic Radiation Therapy+Surgical Resection
Status: Recruiting
Location: See location...
Intervention Type: Radiation, Procedure, Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
Contact Information
Primary
Clinical Trial Recruitment Navigator
cancer.trial.info@cshs.org
3104232133
Time Frame
Start Date: 2021-12-09
Estimated Completion Date: 2026-12
Participants
Target number of participants: 10
Treatments
Experimental: Pembrolizumab with stereotactic radiation therapy and surgical resection
Sponsors
Leads: Chirag G. Patil
Collaborators: Merck Sharp & Dohme LLC, National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov