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Nivolumab + Ipilimumab with Surgery for Glioblastoma
Study Summary
This trial is studying the safety and effectiveness of nivolumab in combination with ipilimumab and surgery when used in the treatment of recurrent 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.Side effects data
From 2023 Phase 3 trial • 521 Patients • NCT04109066Trial Design
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Who is running the clinical trial?
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- I am 18 years old or older.My MRI shows my tumor is growing.You have mental health or addiction issues that could prevent you from following the trial requirements.You are currently or planning to participate in a study involving an experimental drug or device.It's been over 12 weeks since my last radiation therapy, or I have confirmed tumor growth.My doctor has determined that I need surgery.You are allergic to any of the medications being used in the study.I have received radiotherapy as my first treatment.I have been treated with specific immune therapy drugs before.My MRI shows my tumor is growing.I haven't had severe bleeding in the last 6 months.I have another cancer that is getting worse or needs treatment.My cancer has returned once or twice after initial treatment.My brain tumor is a Grade IV glioblastoma without IDH mutation.I have had specific local treatments like brachytherapy or stereotactic surgery.I can provide a tissue sample from my tumor for testing.I am currently being treated for an infection.It has been over 4 weeks since my last surgery or 1 week since my biopsy.I have not received a live vaccine in the last 30 days.I have recovered from major side effects of my previous treatments, except for hair loss and low lymphocyte count.My cancer has an IDH mutation.I have waited the required time after my last cancer treatment before joining this trial.I have an active tuberculosis infection.I have been diagnosed with an immune system disorder.It has been over 4 weeks since my last surgery or 1 week since my biopsy.I need high dose steroids (more than 2 mg/day of dexamethasone or equivalent) for at least 3 days.I am a woman who can have children and have a recent negative pregnancy test.My brain tumor is a type of aggressive cancer known as glioblastoma.I have recovered from major side effects of my previous treatments.My cancer has spread to the lining of my brain or other parts of my body.My recent tests show my organs are working well.I have enough tissue from a previous surgery for testing.I agree to use contraception during and for 7 months after my treatment.I have not taken immunosuppressive drugs, except steroids, in the last 6 months.I have waited the required time after my last cancer treatment before joining this trial.It's been over 12 weeks since my last radiation therapy, or I have confirmed tumor growth.I am able to care for myself but may not be able to do active work.My condition has worsened for the first or second time after improving.I have been treated for an autoimmune disease in the last 2 years.My tumor is mainly in my brainstem or spinal cord.My doctor has decided that I need surgery.I have a bleeding disorder or had significant bleeding in the last year.I have received treatments like bevacizumab or aflibercept.I have received radiotherapy as my first treatment.I have a history of or currently have non-infectious lung inflammation.
- Group 1: Nivolumab and Ipilimumab Before and After Surgery
- Group 2: Nivolumab and Placebo-Ipilimumab Before Surgery, Nivolumab After Surgery
- Group 3: Placebo-Nivolumab and Placebo-Ipilimumab Before Surgery, Nivolumab and Ipilimumab After Surgery
- 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
Has the FDA provided approval for surgical operations?
"Since this is a Phase 1 clinical trial, with limited evidence of safety and efficacy, the risk associated with Surgery was given an assessment of 1."
Have there been prior investigations examining the implications of Surgery?
"At this time, there are 764 trials that study the utilization of Surgery with 86 in Phase 3. Particularly, Pittsburgh, Pennsylvania has several active studies; but globally there exists 42751 such research sites."
Are there multiple health care facilities testing this in the United States?
"4 sites are currently accepting enrolments in this trial, such as the University of California Los Angeles in LA and Dana Farber Cancer Institute in Boston. Additionally, Memorial Sloan Kettering Cancer Center is located in New york City with an additional 4 locations elsewhere."
Is there a cap on the number of participants in this clinical research project?
"Bristol-Myers Squibb, the sponsor of this research, necessitates 60 patients who fulfill the study's criteria for inclusion. The clinical trial will be conducted from 3 sites located in Los Angeles (University of California Los Angeles), Massachusetts and Boston (Dana Farber Cancer Institute) as well as New york."
In what scenarios is Surgery the primary treatment option?
"Surgery is a typical treatment for post-angiogenic therapies, as well as malignant neoplasms, melanoma which cannot be removed surgically, and squamous cell carcinomas."
Is this clinical trial accepting new participants at the present time?
"Confirmed. According to clinicaltrials.gov, this study has been recruiting since February 1st 2021 and the most recent edition was on November 16th 2022. There are 4 trial sites currently contributing to a total of 60 patients needed for the research project."
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