Your session is about to expire
← Back to Search
Immunostimulator
Temozolomide for Malignant Glioma (GMCI Trial)
Phase 1
Waitlist Available
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
GMCI Trial Summary
This trial is testing the safety of combining GMCI, an immunostimulator, plus nivolumab, an immune checkpoint inhibitor, with standard of care radiation therapy, and temozolomide in treating patients with newly diagnosed high-grade gliomas.
Eligible Conditions
- Malignant Glioma
GMCI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Secondary outcome measures
Immune characterization as determined by Cytokines
Immune characterization as determined by Extracellular vesicles (EVs) proteins
Immune profiling - Tumor Tissue
+4 moreGMCI Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort 2: MGMT Methylated & undetermined PatientsExperimental Treatment6 Interventions
After confirmation of high grade glioma, AdV-tk injection into wall of resection cavity. Valacyclovir starting 1-3 days post-surgery for 14 days. Radiation begins approximately day 8. Temozolomide started after complete valacyclovir and continue during radiation then 5 week break and then begin adjuvant temozolomide dosing. Nivolumab every 2 weeks x 26 doses up to 52 weeks. MRI every 8 weeks until progression.
Group II: Cohort 1: MGMT Unmethylated PatientsExperimental Treatment6 Interventions
After confirmation of high grade glioma, AdV-tk injection into wall of resection cavity. Valacyclovir starting 1-3 days post-surgery for 14 days. Radiation begins approximately day 8 and continues for 6 weeks. Temozolomide started after complete valacyclovir and stop when MGMT unmethylated result obtained. Nivolumab every 2 weeks x 26 doses up to 52 weeks. MRI every 8 weeks until progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Valacyclovir
2008
Completed Phase 4
~2520
Temozolomide
2010
Completed Phase 3
~1930
Radiation
2003
Completed Phase 2
~780
AdV-tk
2008
Completed Phase 1
~50
Find a Location
Who is running the clinical trial?
Candel Therapeutics, Inc.Industry Sponsor
11 Previous Clinical Trials
1,237 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,650 Previous Clinical Trials
4,130,796 Total Patients Enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
561 Previous Clinical Trials
33,063 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1: MGMT Unmethylated Patients
- Group 2: Cohort 2: MGMT Methylated & undetermined Patients
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger