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Nivolumab + Immunotherapy for Melanoma
Study Summary
This trial tests how safe and feasible it is to give a cancer drug to people with melanoma brain mets before 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 have another cancer that is getting worse or needs treatment.I don't have any health issues that could affect the trial's results.I need surgery for brain metastases but it's not an emergency.My heart's pumping ability is below normal and hasn't improved.I haven't had major surgery or a serious injury in the last 3 weeks.I have had brain radiation therapy before.I can have surgery 7-10 days after starting treatment.I had surgery to remove brain metastases.My cancer has spread to the lining of my brain and spinal cord.I have an active Hepatitis B or C infection.I am 18 years old or older.Your oxygen level is 92% or higher when measured while you are resting.You need to have a test that shows you are not pregnant before you can join the study.You are allergic to Nivolumab, Ipilimumab, or Relatlimab or any of the ingredients in these medications.I haven't had cancer treatment with a monoclonal antibody in the last 4 weeks.I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.I am a man and do not need to use contraception.I have a brain tumor that cannot be removed with surgery.I am willing to have brain surgery.I have an autoimmune disease treated with medication in the last 2 years.I have or had lung disease or inflammation needing steroids.I haven't had immunotherapy in the last 6 months.I am willing to use birth control during the trial.I can take care of myself and am up and about more than half of my waking hours.I am taking medication to prevent seizures before and after surgery.I am taking more than 3 mg of dexamethasone or its equivalent daily.Your lab test results show that your organs are working properly.I need help with my daily activities due to my health condition.I have had a severe reaction to previous immune therapy.I was treated with a LAG-3 targeted agent, like Relatlimab, over 6 months ago.I have tested positive for HIV or have AIDS.I have brain metastases that can be surgically removed.I am taking 3 mg or less of dexamethasone daily before surgery.I haven't taken dabrafenib or trametinib in the last month.My MRI shows brain lesions that can be surgically removed.Your heart's pumping ability was measured and found to be normal in the past 6 months.I am under 18 years old.I have not had radiation on the tumor that is planned to be removed.I have not had a live vaccine in the last 30 days.I have used herbal treatments for health or my condition within the last 2 weeks.I have had myocarditis in the past.I have an active tuberculosis infection.I haven't had cancer treatment in the last 2 weeks or still have side effects.I am currently being treated for an infection.I have been treated with specific immune therapies within the last 6 months.My cancer diagnosis was confirmed through tissue examination.
- Group 1: Pre-Surgery Nivolumab + Relatlimab(Opdualag)
- Group 2: No Pre-Surgery treatment (Standard of Care)
- Group 3: Pre-Surgery Nivolumab + 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
Are enrollment opportunities for this clinical endeavor still available?
"Affirmative. The clinical trial's page on clinicialtrials.gov attests that recruitment for this research is currently ongoing. Initially posted on 19th January 2023, the study was last updated on 30th January and requires 24 participants from 2 medical centres."
What is the scope of participation in this clinical trial?
"Affirmative: The information shared on clinicaltrials.gov suggests that this research study is in the process of recruiting individuals. It was first posted on January 19th 2023 and its most recent update occurred at the end of the month, with a target enrollment size of 24 participants across two sites."
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