Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT03707457
Brief Summary:
This research is being done to test if it is safe to give nivolumab with targeted immunotherapy drugs for recurrent glioblastoma (GBM), a type of brain tumor. The study doctors believe that giving immunotherapy drugs that match the biomarkers in a tumor will help the immune system fight the tumor. Tumor tissue collected during surgery will be tested for certain biomarkers to determine which immunotherapy might best target the tumor.
The combination immunotherapy arms include:
Arm A: Nivolumab + anti-GITR Arm B: Nivolumab + IDO1 inhibitor Arm C: Nivolumab + Ipilimumab
Detailed Description:
PRIMARY OBJECTIVE
1\. To determine safety of each of the following study agents, anti-GITR, IDO1 inhibitor, and ipilimumab, in combination with nivolumab (BMS-936558) flat dose in patients with first recurrence of GBM.
SECONDARY OBJECTIVES
1. To estimate toxicity
2. To estimate progression-free survival
3. To estimate overall survival
4. To evaluate pain for patients undergoing the treatment of anti-GITR, IDO1 inhibitor, and ipilimumab, in combination with nivolumab.
EXPLORATORY OBJECTIVES
1. To characterize the immune response during and after treatment as measured by immunohistochemistry, and other T cells etc. in peripheral blood
2. To characterize the pharmacodynamic and genomic activity in tumor tissue as target inhibition
3. To characterize radiographic response
4. Genetic characterization of correlative samples
Study:
NCT03707457
Study Brief:
Protocol Section:
NCT03707457