Calendario›CADL›AdV-tk · GMCI

AdV-tk · GMCI

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

Ensayo de Candel Therapeutics, Inc. en Glioma, Malignant (del registro, en inglés).

Fase

Fase 1

Estado

Completado

Participantes

41

previstos

Centros

5

Fin del objetivo primario

jun 2023

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en feb 2018.

Qué mide

Incidence of adverse events (del registro, en inglés) (hasta 2 años)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe 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

Más ensayos de CADL

Todos los de CADL, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT03576612), actualizada en feb 2025.