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Immunotherapy + Targeted Therapy + Radiation for Glioblastoma
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Cohort I (radiation, temozolomide, BMS-986205, nivolumab)
- Group 2: Cohort II (radiation, BMS-986205, nivolumab)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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."
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."
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."
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