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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])
Stable or decreasing dose of steroids for >= 7 days prior to registration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am not taking any steroids as of the first day of the study.
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My steroid dose has been stable or decreasing for the last week.
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I agree to use effective birth control during and for 5 months after the study.
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I have a grade IV brain tumor with known MGMT methylation status.
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I am able to care for myself but may not be able to do active work.
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I have a grade IV brain tumor with known MGMT methylation status, diagnosed recently.
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I can provide tumor samples from my brain surgery or biopsy for testing.
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My kidney function, measured by creatinine levels, is within normal range.
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I am able to care for myself but may not be able to do active work.
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I had an MRI before and after my tumor surgery, or I will have one before starting the study treatment.
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I am not taking any steroids as I start this study treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events (AEs)
Secondary outcome measures
Median duration of response
Median survival
Median time to disease progression
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Cohort II (radiation, BMS-986205, 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: Cohort I (radiation, temozolomide, BMS-986205, 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
Radiation Therapy
2017
Completed Phase 3
~7250
Temozolomide
FDA approved
Nivolumab
FDA approved
Find a Location
Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
917,213 Total Patients Enrolled
11 Trials studying Glioblastoma
420 Patients Enrolled for Glioblastoma
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,135 Total Patients Enrolled
322 Trials studying Glioblastoma
23,097 Patients Enrolled for Glioblastoma
Rimas V Lukas, MDPrincipal InvestigatorNorthwestern University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any unmanaged ongoing illnesses.I had my diagnostic surgery or biopsy less than 5 weeks ago.My organs and bone marrow are working well.I or my family have a history of conditions that increase the risk of methemoglobinemia.I had specific MRI scans before and within 3 days after my surgery or biopsy.I have fully recovered from any surgery or its complications before joining the study.I am not taking any steroids as of the first day of the study.I had a Gliadel wafer placed during my brain surgery.I have not had chemotherapy in the last 2 years.My steroid dose has been stable or decreasing for the last week.I have an autoimmune disease.I have not taken BMS-986205 or any IDO1 inhibitors before.My heart is healthy and I haven't had heart disease in the last 6 months.I agree to use effective birth control during and for 5 months after the study.I have a grade IV brain tumor with known MGMT methylation status.I do not have any severe illnesses that could make this treatment unsafe for me.I have had cancer before.You currently have a problem with alcohol or drug addiction.I have previously received treatments targeting immune checkpoints.You have experienced serotonin syndrome before.Your platelet count is at least 100,000 per cubic millimeter of blood.The hospital will perform a test called pyrosequencing to check if your MGMT gene is methylated as a standard procedure.I am on steroids or other drugs that affect my immune system.I am able to care for myself but may not be able to do active work.I have a history of G6PD deficiency or other blood disorders.You have enough white blood cells called neutrophils, with a count of at least 1500 per cubic millimeter of blood.You cannot be currently enrolled in another clinical trial or have taken part in one within the last 30 days before starting this study.I haven't taken herbal supplements or traditional medicines in the last 14 days.I have or had lung inflammation treated with steroids.I have a grade IV brain tumor with known MGMT methylation status, diagnosed recently.I can provide tumor samples from my brain surgery or biopsy for testing.I am allergic to certain cancer medications similar to nivolumab or temozolomide.I have undergone radiation therapy for my brain.My tumor samples from surgery or biopsy are available for review.I have a G6PD deficiency.I am currently undergoing Optune therapy.My kidney function, measured by creatinine levels, is within normal range.I am able to care for myself but may not be able to do active work.I had an MRI before and after my tumor surgery, or I will have one before starting the study treatment.I am not taking any steroids as I start this study treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort I (radiation, temozolomide, BMS-986205, nivolumab)
- Group 2: Cohort II (radiation, BMS-986205, nivolumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are taking part in this medical experiment?
"Affirmative. Documents on clinicaltrials.gov reveal that this medical trial is actively trying to find participants, having been first posted in August 2019 and most recently edited in June 2020. 30 individuals are required from 1 site for the study."
Answered by AI
What is the risk profile associated with BMS-986205, an IDO1 Inhibitor?
"Due to the early nature of this study, Power assigned a rating of 1 for BMS-986205's safety profile as there is only minimal clinical data supporting its efficacy and security."
Answered by AI
What conditions is the IDO1 Inhibitor BMS-986205 commonly employed to address?
"IDO1 Inhibitor BMS-986205 is an effective therapy for malignant neoplasms, particularly unresectable melanoma and squamous cell carcinoma."
Answered by AI
Are there any remaining patient opportunities for this research?
"Clinicaltrials.gov reports that this medical exploration is recruiting patients, beginning on August 13th 2019 and most recently updated June 30th 2020."
Answered by AI
What other research investigations have been conducted with regard to IDO1 Inhibitor BMS-986205?
"Presently, the number of active clinical trials exploring IDO1 Inhibitor BMS-986205 stands at 913 with 104 Phase 3 experiments. The majority are situated in Houston, Texas; however, there are an aggregate 44739 locations running tests for this particular inhibitor."
Answered by AI
Is this an experimental investigation of a medical treatment?
"Since 2002, IDO1 Inhibitor BMS-986205 has been under investigation. The initial trial was sponsored by Schering-Plough and involved 60 patients; the drug received Phase 2 approval following this first experiment. Currently, there are 913 active trials for IDO1 Inhibitor BMS-986205 in 2432 cities across 51 nations."
Answered by AI
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