CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 39 enrolled / 39 target
Drug / intervention
INCMGA00012 +3 moredrug
Likely dose
INCMGA00012 500mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04225039
NCT04225039Phase 2ActiveUpdate Overdue (0.5/mo)Completion was 45mo ago
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A Phase II Study of the Anti-GITR Agonist INCAGN1876 and the PD-1 Inhibitor INCMGA00012 in Combination With Stereotactic Radiosurgery in Recurrent Glioblastoma

University of Pennsylvania·interventional·Posted Jan 13, 2020·Updated Jun 23, 2026

In Brief

A Phase 2 clinical trial evaluating INCMGA00012, INCAGN01876, and 2 other interventions for Glioblastoma. Active but no longer recruiting, targeting 39 participants across 1 site.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlioblastoma
CountriesUnited States
CollaboratorsIncyte Corporation

Timeline

Phase 2Active
2020202120222023202420252026202720282029
First PostedJan 13, 2020
Enrollment StartJun 23, 2020
Primary CompletionSep 8, 2022
Study CompletionApr 30, 2029
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 6.5 years ago

Arms & Interventions

Cohort Aexperimental

Subjects in this arm (N=16) receive a single priming dose of both INCMGA00012 (500mg) and INCAGN01876 (300mg) prior to stereotactic radiosurgery (SRS), then undergo SRS (8 Gy x 3 fractions). Following SRS, INCMGA00012 (500mg IV every 4 weeks) and INCAGN01876 (300mg IV every 2 weeks) are resumed and continued until disease progression, unacceptable toxicity, or for 2 years, whichever occurs first.

Drug: INCMGA00012Drug: INCAGN01876Drug: SRS
Cohort B sub-arm #1experimental

Subjects in this arm (N=8) receive neoadjuvant immunotherapy INCMGA00012 (500mg) + INCAGN01876 (300mg) + SRS. Subjects then undergo surgery. Postoperatively, the immunotherapy combination of INCMGA00012 (500 mg IV every 4 weeks) and INCAGN01876 (300mg IV every 2 weeks) is resumed and continued until disease progression, unacceptable toxicity, or for 2 years, whichever occurs first.

Drug: INCMGA00012Drug: INCAGN01876Drug: SRSProcedure: Brain surgery
Cohort B sub-arm #2experimental

Subjects in this arm (N=8) receive neoadjuvant immunotherapy INCMGA00012 + INCAGN01876 (without SRS). Subjects then undergo surgery. Postoperatively, the immunotherapy combination of INCMGA00012 (IV every 4 weeks) and INCAGN01876 (IV every 2 weeks) is resumed and continued until disease progression, unacceptable toxicity, or for 2 years, whichever occurs first.

Drug: INCMGA00012Drug: INCAGN01876Procedure: Brain surgery

Interventions

INCMGA00012drug

500mg IV neoadjuvant treatment; 500 mg adjuvant treatment

INCAGN01876drug

300mg IV neoadjuvant treatment; 300 mg adjuvant treatment

SRSdrug

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

Brain surgeryprocedure

maximal safe surgical resection of the tumor.