GMCI, Nivolumab, and Radiation Therapy in Treating Patients With Newly Diagnosed High-Grade Gliomas

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Candel Therapeutics, Inc.
Study ID
NCT03576612
Phase
PHASE1
Status
Completed

Conditions

  • Glioma, Malignant

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AdV-tk — BIOLOGICAL
    Given IT
  • Valacyclovir — DRUG
    Given PO days 1-14; 1-3 days post surgery
  • Radiation — RADIATION
    Undergo RT, 60Gy in 30 daily fractions M-F for 6weeks
  • Temozolomide — DRUG
    Given PO during RT 75mg/m2 daily during RT Post RT cycle 1: 150mg/m2 days 1-5 150mg/m2 cycle 2-6: days 1-5 (150-200mg/m2)
  • Nivolumab — BIOLOGICAL
    day 15 post surgery 240mg IV q2wks x 26 doses , up to 52 weeks
  • Laboratory Biomarker Analysis — OTHER
    correlative studies

Study Details

The purpose of this phase I trial is to test the safety of combining GMCI, an immunostimulator, plus nivolumab, an immune checkpoint inhibitor (ICI), with standard of care radiation therapy, and temozolomide in treating patients with newly diagnosed high-grade gliomas. Gene Mediated Cytotoxic Immunotherapy (GMCI) involves the use of aglatimagene besadenovec (AdV-tk) injection into the tumor site and oral valacyclovir to kill tumor cells and stimulate the immune system. Nivolumab is an immune checkpoint inhibitor that may also stimulate the immune system by blocking the PD-1 immune suppressive pathway. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors and temozolomide is a chemotherapy drug that kills tumor cells. Giving GMCI, nivolumab, radiation therapy, and temozolomide may work better in treating patients with high-grade gliomas

Key Dates

Start date
Feb 27, 2018
Status verified
Feb 2025
Primary completion
Jun 30, 2023
Completion
Jun 30, 2023

Study Design

Enrollment
41 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: MGMT Unmethylated Patients
    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.
  • Experimental: Cohort 2: MGMT Methylated & undetermined Patients
    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.

Primary Outcome Measure

Incidence of adverse events [ Time Frame: Up to 2 years ]

Locations (5)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02215-
Henry Ford HospitalDetroitMichigan48202-
Wake Forest University Comprehensive Cancer CenterWinston-SalemNorth Carolina27157-
Abrams Cancer Center of the University of PennsylvaniaPhiladelphiaPennsylvania19104-
Hillman Cancer Center at University of Pittsburgh Cancer InstitutePittsburghPennsylvania15232-

Find similar trials in Boston, MA

By research site
Dana Farber Cancer Institute· Boston, MAHenry Ford Hospital· Detroit, MIWake Forest University Comprehensive Cancer Center· Winston-Salem, NCAbrams Cancer Center of the University of Pennsylvania· Philadelphia, PAHillman Cancer Center at University of Pittsburgh Cancer Institute· Pittsburgh, PA

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