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Biomarker-Driven Therapy Using Immune Activators With Nivolumab in Patients With First Recurrence of Glioblastoma

Glioblastoma Clinical Trial

Official title:
Phase I Protocol to Assess Safety of Biomarker-Driven Therapy Using Selective Immune Activators in Combination With Anti-PD-1 (Nivolumab) in Patients With First Recurrence of Glioblastoma

Clinical Trial 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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03707457
Study type Interventional
Source Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Contact
Status Terminated
Phase Phase 1
Start date March 22, 2019
Completion date June 18, 2020
View Details
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