Brain surgery for Glioblastoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Glioblastoma
Brain surgery - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying a combination of two immunotherapy drugs and stereotactic radiosurgery to see if it is safe and effective in treating patients with recurrent glioblastoma.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Glioblastoma

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 84 months

25 months
Incidence of Treatment-Emergent Adverse Events as assessed by NCI CTCAE v 5.0
26 months
Objective radiographic response (ORR)
84 months
Overall survival
Progression Free Survival

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Glioblastoma

Trial Design

3 Treatment Groups

Cohort A
1 of 3
Cohort B sub-arm #2
1 of 3
Cohort B sub-arm #1
1 of 3
Experimental Treatment

32 Total Participants · 3 Treatment Groups

Primary Treatment: Brain surgery · No Placebo Group · Phase 2

Cohort AExperimental Group · 3 Interventions: SRS, INCAGN01876, INCMGA00012 · Intervention Types: Drug, Drug, Drug
Cohort B sub-arm #2Experimental Group · 3 Interventions: INCAGN01876, INCMGA00012, Brain surgery · Intervention Types: Drug, Drug, Procedure
Cohort B sub-arm #1Experimental Group · 4 Interventions: SRS, INCAGN01876, INCMGA00012, Brain surgery · Intervention Types: Drug, Drug, Drug, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SRS
2014
N/A
~9190
INCAGN01876
2016
Completed Phase 2
~250
Retifanlimab
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 84 months

Who is running the clinical trial?

Incyte CorporationIndustry Sponsor
309 Previous Clinical Trials
46,280 Total Patients Enrolled
4 Trials studying Glioblastoma
594 Patients Enrolled for Glioblastoma
University of PennsylvaniaLead Sponsor
1,816 Previous Clinical Trials
41,115,061 Total Patients Enrolled
7 Trials studying Glioblastoma
166 Patients Enrolled for Glioblastoma
Stephen Bagley, MD, MSCEPrincipal InvestigatorUniversity of Pennsylvania

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
If you have a histologically proven diagnosis of World Health Organization (WHO) grade IV glioblastoma, OR histopathologically proven diagnosis of gliosarcoma, OR molecular diagnosis of glioblastoma per c-IMPACT-NOW criteria ("diffuse astrocytic glioma, IDH-wildtype, with molecular features of glioblastoma, WHO grade IV"), you are eligible for this study.
Cohort B's sub-arm 2 tumors can be any size, and do not need to be amenable to SRS.
This means that the surgery must be clinically necessary as determined by their care providers in order for these patients to be in Cohort B.
The tumor O-6-methylguanine-deoxyribonucleic acid (DNA) methyltransferase (MGMT) methylation status must be known from a prior GBM tumor specimen; results of commonly used methods for MGMT methylation testing (e.g
A person who has received chemotherapy that uses nitrosourea will have a 6-week wait before they are allowed to donate blood.
agent "In 3 weeks, the patient will be treated with a cytotoxic chemotherapy agent that is not a nitrosourea.
for all lesions Cohort A and Sub-Arm 1 of Cohort B only: Patient must have at least one measurable (>=1cm x 1cm) contrast-enhancing tumor focus for which stereotactic radiosurgery (SRS) is clinically indicated, as determined by the Investigator, and must be able to achieve radiation target coverage without exceeding dose constraints
Patients are allowed to have had treatment for an unlimited number of prior relapses, but must not have had prior bevacizumab or other vascular endothelial growth factor (VEGF/VEGFR) inhibitors
People with a glial tumor that has come back after radiation therapy must have evidence of tumor progression by MRI scan in order to participate in the study.
therapy It will take 12 weeks for the radiation therapy to be completed.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 5th, 2021

Last Reviewed: October 3rd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.