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Immune Checkpoint Inhibitors + Temozolomide for Brain Cancer
Study Summary
This trial is studying the changes in immune cells in the blood of people with newly diagnosed GBM or gliosarcoma, who take ipilimumab and nivolumab, along with temozolomide.
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.Side effects data
From 2022 Phase 3 trial • 541 Patients • NCT02041533Trial Design
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Who is running the clinical trial?
Media Library
- I am mostly able to care for myself.I have had immune therapy, like a vaccine or dendritic cell vaccine.You have had a serious allergic reaction to any type of antibody treatment in the past.You have an intrauterine device (IUD) inserted.My hemoglobin level is above 9.0 g/dL, or I can receive a transfusion to reach this.I have or had hepatitis.I am not taking more than 30 mg of cortisone or its equivalent daily.I finished my chemoradiation treatment no more than 5 weeks ago.I have conditions like vitiligo, thyroid issues managed with hormones, or controlled arthritis but no severe organ involvement.I do not have any uncontrolled illnesses that could interfere with the study.I am allergic to medications similar to nivolumab, ipilimumab, or temozolomide.I have been recently diagnosed with glioblastoma or gliosarcoma.My organs and bone marrow are functioning well.I have had cancer before, but it won't affect this treatment's safety or results.My kidney function is normal, with creatinine levels at or below 1.7 mg/dL.I had surgery to remove almost all of a brain tumor located above the cerebellum.I am aware of the need for birth control during and up to 6 months after the study if I am female, or my partner is, and participating.I do not have an active or history of severe autoimmune disease.My cancer is getting worse, as shown by tests or scans.I am not pregnant or breastfeeding.I am 18 years old or older.I am using a barrier method of contraception.I have had Gliadel wafer or local brachytherapy, but Tumor Treating Fields are okay.You are currently taking any experimental medications.You are using hormone-based birth control methods.
- Group 1: Arm 1
- Group 2: Arm 2
- 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
What are the possible risks associated with Nivolumab?
"Given that this is a Phase 2 trial, and thus there is only some data supporting safety with no data supporting efficacy, our team at Power estimates the safety of Nivolumab to be a 2."
What are the most common conditions that Nivolumab is used for?
"Nivolumab is not only commonly used to treat previous anti-angiogenic therapy, but it can also be employed against other maladies such as unresectable melanoma and squamous cell carcinoma."
What is the extent of research on Nivolumab's effects?
"As of now, there are 796 ongoing clinical trials for Nivolumab with 86 in Phase 3. While many of the clinical trials for Nivolumab are based in Pittsburgh, Pennsylvania, there are 43300 total locations running trials for Nivolumab."
Are investigators still recruiting participants for this research trial?
"The listings on clinicaltrials.gov show that this experiment is still recruiting patients. The trial was first advertised on December 8th, 2021 and the most recent update was on October 29th, 2022. A total of 48 people are needed for the study which is only happening at 1 location."
Just to be clear, how many people are included in the experimental group for this project?
"Yes, that is correct. The clinical trial is presently seeking candidates, as indicated by the data on clinicaltrials.gov. This particular trial was initially posted on 12/8/2021 and was most recently edited on 10/29/2022. The recruitment goal for this trial is 48 participants from 1 site."
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