Viewing Study NCT03707457


Ignite Creation Date: 2025-12-24 @ 6:40 PM
Ignite Modification Date: 2026-02-19 @ 3:39 AM
Study NCT ID: NCT03707457
Status: TERMINATED
Last Update Posted: 2020-07-02
First Post: 2018-10-10
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Biomarker-Driven Therapy Using Immune Activators With Nivolumab in Patients With First Recurrence of Glioblastoma
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:

Study Overview

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
Status: TERMINATED
Status Verified Date: 2020-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Funding/material support withdrawn
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?:

Secondary ID Infos

Secondary ID Type Domain Link View
IRB00129944 OTHER JHM IRB View