Nivolumab, BMS-986205, and Radiation Therapy With or Without Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma
NCT04047706 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2025-06-29
Summary
This phase I trial studies the side effects of nivolumab, BMS-986205, and standard radiation therapy with or without temozolomide in treating patients with new diagnosed glioblastoma. Immunotherapy with nivolumab, may induce changes in body?s immune system and may interfere with the ability of tumor cells to grow and spread. BMS-986205 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab and BMS-986205 may work better compared to radiation therapy and temozolomide alone in treating patients with newly diagnosed glioblastoma.
Conditions
Interventions
- DRUG
-
IDO1 Inhibitor BMS-986205 25mg
Given PO
- DRUG
-
Given IV
- RADIATION
-
Radiation Therapy
Undergo radiation therapy
- DRUG
-
Given PO
- DRUG
-
IDO1 Inhibitor BMS-986205 50 mg
Given PO
- DRUG
-
IDO1 Inhibitor BMS-986205 100 mg
Given PO
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH - lead OTHER
Principal Investigators
-
Rimas V Lukas, MD · Northwestern University
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-08-13
- Primary Completion
- 2027-02-15
- Completion
- 2027-06-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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