Symptoms and General Pathology

All Conditions

Neoplasms

Rare Diseases

Recurrence

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Disease Attributes

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Nivolumab

Antibodies

Antibodies, Monoclonal

Ipilimumab

Immunoglobulins

MK-4166

Immunologic Factors

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Patients receive nivolumab intravenously (IV) over 30 minutes and anti-GITR intravenously (IV) over 30 minutes on Day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients receive nivolumab intravenously (IV) over 30 minutes on Day 1 and IDO1 inhibitor daily by mouth. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients receive nivolumab intravenously (IV) over 30 minutes and ipilimumab intravenously (IV) over 90 minutes on Day 1. Courses repeat every 21 days for up to 4 doses. After ipilimumab is discontinued, courses of nivolumab repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients receive nivolumab intravenously (IV) over 30 minutes on Day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients receive anti-GITR intravenously (IV) over 30 minutes on Day 1 of the first cycle of nivolumab after arm assignment. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Anti-GITR Monoclonal Antibody MK-4166

Patients receive IDO1 inhibitor by mouth daily beginning on Day 1 of the first cycle of nivolumab after arm assignment. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

IDO1 inhibitor INCB024360

Patients receive ipilimumab intravenously (IV) over 90 minutes on Day 1 of the first cycle of nivolumab after arm assignment. Courses repeat every 21 days for up to 4 doses in the absence of disease progression or unacceptable toxicity.

Michael Lim, MD

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

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

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

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

The proportion of subjects who experienced grade ≥3 toxicities will be estimated, along with 95% confidence intervals by each type of toxicity.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Biomarker-Driven Therapy Using Immune Activators With Nivolumab in Patients With First Recurrence of Glioblastoma	NCT03707457	Glioblastoma Glioblastoma Mu...	Nivolumab Anti-GITR Monoc... IDO1 inhibitor ... Ipilimumab	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Biomarker-Driven Therapy Using Immune Activators With Nivolumab in Patients With First Recurrence of Glioblastoma	NCT03707457	Glioblastoma Glioblastoma Mu...	Nivolumab Anti-GITR Monoc... IDO1 inhibitor ... Ipilimumab	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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