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

Summary

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

Timeline

Start

2018-02-27

Primary completion

2023-06-30

Completion

2023-06-30

Publications

• Wen PY, Manzanera A, Duault C, Gonzalez-Kozlova E, Lopez L, Grossman SA, Ye X, Fisher J, Lee I, Walbert T, Snyder J, Brem S, Desai A, Bagley SJ, Kakani C, Strowd R, Tatter S, Laxton A, Lesser G, Amankulor N, Lieberman F, Drappatz J, Mantica M, Triggs D, Haymaker C, Wistuba II, Al-Atrash G, Mendoza Perez J, Futreal A, Little LD, Islam MDH, Duose D, Jiang P, Reuben A, Lawler SE, Pichavant M, Gentles A, Bendall S, Kong A, Camacho C, Del Valle D, Kim-Schulze S, Gnjatic S, Sharon E, Nowicki MO, Peruzzi P, Lane D, Aguilar-Cordova E, Aguilar LK, Nichols G, Dwyer J, Tak PP, Maecker H, Barone F, Chiocca EA. A multi-institutional phase 1 clinical trial exploring upfront multimodal standard of care and combined immunotherapies for newly diagnosed glioblastoma. Neuro Oncol. 2025 Oct 1;27(10):2617-2631. doi: 10.1093/neuonc/noaf079.

Drugs

Indications