← Back to Search

IDO1 Inhibitor

Immunotherapy + Targeted Therapy + Radiation for Glioblastoma

Phase 1

Waitlist Available

Led By Rimas V Lukas, MD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Note: Patients must be off of all steroids at the time of initiation of study treatment (day 1 [D#1])

FOCBP and males must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 5 months following completion of therapy

Must not have

Uncontrolled intercurrent illness

Personal or family history or presence of cytochrome b5 reductase deficiency or other diseases that puts them at risk of methemoglobinemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing a combination of immunotherapy and targeted therapy with radiation therapy, with or without chemotherapy, to see if it is more effective than standard radiation therapy with or without chemotherapy in treating patients with newly diagnosed glioblastoma.

Who is the study for?

This trial is for adults with newly diagnosed glioblastoma who have stable or decreasing steroid use, adequate blood counts and organ function, and a performance score of >=70%. They must not have had recent brain radiation or chemotherapy, certain genetic deficiencies or lung diseases, other cancers within 2 years, known allergies to the drugs tested, be pregnant/nursing, HIV/AIDS positive, drug/alcohol dependent or on immunosuppressants.

What is being tested?

The study tests if nivolumab (an immune system modulator), BMS-986205 (an enzyme blocker), combined with standard radiation therapy are more effective when temozolomide (a chemotherapy drug) is added. It aims to see which combination better stops tumor growth in patients with glioblastoma.

What are the potential side effects?

Possible side effects include immune-related reactions that can affect organs like the liver and lungs; fatigue; skin issues; hormonal gland problems; infusion reactions from the drugs being administered; as well as typical chemotherapy side effects such as nausea and hair loss.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am not taking any steroids as of the first day of the study.

Select...

I agree to use effective birth control during and for 5 months after the study.

Select...

I have a grade IV brain tumor with known MGMT methylation status.

Select...

I am able to care for myself but may not be able to do active work.

Select...

My kidney function, measured by creatinine levels, is within normal range.

Select...

I am able to care for myself but may not be able to do active work.

Select...

I am not taking any steroids as I start this study treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have any unmanaged ongoing illnesses.

Select...

I or my family have a history of conditions that increase the risk of methemoglobinemia.

Select...

I had a Gliadel wafer placed during my brain surgery.

Select...

I have an autoimmune disease.

Select...

I have not taken BMS-986205 or any IDO1 inhibitors before.

Select...

I have had cancer before.

Select...

I have previously received treatments targeting immune checkpoints.

Select...

I am on steroids or other drugs that affect my immune system.

Select...

I have a history of G6PD deficiency or other blood disorders.

Select...

I have or had lung inflammation treated with steroids.

Select...

I am allergic to certain cancer medications similar to nivolumab or temozolomide.

Select...

I have undergone radiation therapy for my brain.

Select...

I have a G6PD deficiency.

Select...

I am currently undergoing Optune therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events (AEs)

Secondary study objectives

Median duration of response

Median survival

Median time to disease progression

+4 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Unmethylated Cohort (radiation, BMS-986205 50mg QD, nivolumab)Experimental Treatment3 Interventions

RADIATION THERAPY: Patients with MGMT unmethylated promoter undergo radiation therapy 5 days per week (Monday-Friday) for up to 6 weeks. Patients also receive IDO1 inhibitor BMS-986205 PO QD and nivolumab IV over 30 minutes every 2 weeks for up to 6 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive IDO1 inhibitor BMS-986205 PO QD on days 1-28 and nivolumab IV over 30 minutes on days 1 and 15 of cycles 1-5 and on day 1 of subsequent cycles. Cycles repeats every 28 days for up to 2 years in the absence of disease progression, unacceptable toxicity, withdrawal of consent, the study ends, or until Q4W dosing begins.

Group II: Unmethylated Cohort (radiation, BMS-986205 100mg QD, nivolumab)Experimental Treatment3 Interventions

Group III: Methylated Cohort (radiation, temozolomide, BMS-986205 25mg QD, nivolumab)Experimental Treatment4 Interventions

RADIATION THERAPY: Patients with MGMT methylated promoter undergo radiation therapy 5 days per week (Monday-Friday) for up to 6 weeks. Patients also receive temozolomide PO QD, IDO1 inhibitor BMS-986205 PO QD, and nivolumab IV over 30 minutes every 2 weeks for up to 6 weeks in the absence of disease progression, unacceptable toxicity, withdrawal of consent, the study ends, or until Q4W dosing begins. MAINTENANCE THERAPY: Patients receive IDO1 inhibitor BMS-986205 PO QD on days 1-28 and nivolumab IV over 30 minutes on days 1 and 15 of cycles 1-5 and on day 1 of subsequent cycles. Within 4 weeks of radiation therapy completion, patients also receive temozolomide PO QD on days 1-5 of cycles 2-6. Cycles repeats every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

FDA approved

Radiation Therapy

2017

Completed Phase 3

~7250

Temozolomide

FDA approved