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Anti-GITR/Anti-PD1/Stereotactic Radiosurgery, in Recurrent Glioblastoma

NCT04225039 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2025-08-15

Study results available
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Summary

This is a phase II study of the combination of the GITR agonist monoclonal antibody INCAGN01876, the anti-PD1 monoclonal antibody INCMGA00012, and stereotactic radiosurgery (SRS) for recurrent Glioblastoma (GBM). The investigators hypothesize that the proposed regimen will be safe and stimulate a robust anti-tumor immune response and result in improved tumor responses.

Conditions

Interventions

DRUG

INCMGA00012

500mg IV neoadjuvant treatment; 500 mg adjuvant treatment

DRUG

INCAGN01876

300mg IV neoadjuvant treatment; 300 mg adjuvant treatment

DRUG

SRS

administered over the course of 3 consecutive business days (8 Gy x 3 fractions, one fraction per day, total dose 24 Gy).

PROCEDURE

Brain surgery

maximal safe surgical resection of the tumor.

Sponsors & Collaborators

Principal Investigators

  • Stephen Bagley, MD, MSCE · University of Pennsylvania

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-23
Primary Completion
2022-09-08
Completion
2029-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04225039 on ClinicalTrials.gov