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Immunotherapy for Meningioma
Study Summary
This trial is testing whether two immunotherapy drugs can treat people with a type of brain tumor that has returned after surgery.
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 am able to care for myself but may not be able to do active work.I have received CTLA-4 therapy before, as part of cohort 2.My meningioma is confirmed and has returned or is getting worse.I haven't taken drugs that weaken my immune system in the last 3 months.I am allergic to one or more components of the study drug.I am not pregnant.My grade I tumor did not respond to radiation therapy.I haven't taken high dose steroids in the last 2 weeks.I have another cancer that is getting worse or needs treatment.I have not had a brain abscess in the last 6 months.I am a candidate for a specific type of targeted radiation therapy.My blood tests show my organs and bone marrow are working well.I have not taken medication for an autoimmune disease in the last 3 months.I am currently receiving IV treatment for an infection.I have had multiple treatments, including surgery and radiation, for my condition.I have been treated with PD-1 or PD-L1 therapy before.I have not received a live vaccine in the last 30 days.My condition involves metastatic meningiomas.My tumor is mainly in my brainstem or spinal cord.My MRI shows bleeding in or around my tumor, but it's mild or stable.You have a positive test for hepatitis B or hepatitis C virus, which means you have an ongoing infection.You had a severe allergic reaction to any type of monoclonal antibody.I have not had surgery or a major injury in the last 28 days.I do not have any unmanaged ongoing illnesses.
- Group 1: Cohort 1 (original cohort): Nivolumab Monotherapy
- Group 2: Cohort 2: Nivolumab in Combination with Ipilimumab
- 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 have patients responded positively to Nivolumab - 240 mg treatments?
"Nivolumab - 240 mg has been shown to be an effective anti-angiogenic treatment in the past and can also help patients with malignant neoplasms, unresectable melanoma, and squamous cell carcinoma."
What are the most commonly experienced side effects of Nivolumab - 240 mg?
"There is some clinical data suggesting that Nivolumab - 240 mg is safe, but as this is only a Phase 2 trial, there is no information currently available to support its efficacy."
Are there any unfilled openings for volunteers in this clinical experiment?
"Yes, this information is available on the website clinicaltrials.gov. The trial was first posted on March 1st, 2016 and updated as recently as January 3rd, 2022."
How many individuals are a part of this ongoing test?
"That is correct, the clinical trial detailed on clinicaltrials.gov appears to be actively recruiting patients. The listing specifies that 50 individuals are needed for the study conducted at 1 location. This information was first posted on March 1st, 2016 and last updated January 3rd, 2022."
What is the past research on Nivolumab - 240 mg?
"At present, there are 796 different studies ongoing that involve the use of Nivolumab - 240 mg. Of these, 86 are classified as Phase 3 trials. Although several of the Nivolumab - 240 mg studies originate in Pittsburgh, Pennsylvania, there are a total of 43300 locations around the world where patients can participate in these trials."
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