Brain surgery for Glioblastoma
Phase-Based Progress Estimates
Effectiveness
Safety
Glioblastoma
Brain surgery - ProcedureEligibility
18+
All Sexes
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Eligibility
18+
All Sexes
What conditions do you have?
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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
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
This is further along than 68% of similar trials
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 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.
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Conditions
Cancer Related
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