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Checkpoint Inhibitor
Nivolumab + Immunotherapy for Melanoma
Phase < 1
Waitlist Available
Led By Yolanda Pina, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient eligible for surgery in the 7-10 days after initial treatment
Patients who had prior surgical resection of MBM are eligible to enroll
Must not have
Has a known additional malignancy that is progressing or requires active treatment
Had major surgical procedure, open biopsy, or significant traumatic injury within 21 days prior to day 1 of treatment on study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 30 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests how safe and feasible it is to give a cancer drug to people with melanoma brain mets before surgery.
Who is the study for?
This trial is for adults with melanoma brain metastases who can have surgery to remove these metastases. They must not have had immunotherapy in the last 6 months, be willing to provide samples for research, and meet certain health criteria including organ function and performance status. Women of childbearing potential must use contraception.
What is being tested?
The study tests the safety of a single dose of Nivolumab combined with either Ipilimumab or Relatlimab given before surgical removal of brain tumors from melanoma patients. The drugs are administered 7-10 days prior to scheduled craniotomy.
What are the potential side effects?
Potential side effects include immune-related reactions that could affect various organs, infusion reactions similar to allergic responses, fatigue, possible hormonal imbalances, and an increased risk of infections due to immune system suppression.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can have surgery 7-10 days after starting treatment.
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I had surgery to remove brain metastases.
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I am 18 years old or older.
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I am willing to have brain surgery.
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I haven't had immunotherapy in the last 6 months.
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I can take care of myself and am up and about more than half of my waking hours.
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I have brain metastases that can be surgically removed.
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I am taking 3 mg or less of dexamethasone daily before surgery.
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I haven't taken dabrafenib or trametinib in the last month.
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My MRI shows brain lesions that can be surgically removed.
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My cancer diagnosis was confirmed through tissue examination.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have another cancer that is getting worse or needs treatment.
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I haven't had major surgery or a serious injury in the last 3 weeks.
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My cancer has spread to the lining of my brain and spinal cord.
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I have an active Hepatitis B or C infection.
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I haven't had cancer treatment with a monoclonal antibody in the last 4 weeks.
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I have a brain tumor that cannot be removed with surgery.
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I have an autoimmune disease treated with medication in the last 2 years.
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I have or had lung disease or inflammation needing steroids.
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I am taking more than 3 mg of dexamethasone or its equivalent daily.
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I need help with my daily activities due to my health condition.
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I have had a severe reaction to previous immune therapy.
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I have tested positive for HIV or have AIDS.
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I am under 18 years old.
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I have not had radiation on the tumor that is planned to be removed.
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I have had myocarditis in the past.
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I have an active tuberculosis infection.
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I haven't had cancer treatment in the last 2 weeks or still have side effects.
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I am currently being treated for an infection.
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I have been treated with specific immune therapies within the last 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 30 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 30 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Comparison of immune cell population per treatment arm
Feasibility: Ability to recruit per treatment arm
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Pre-Surgery Nivolumab + Relatlimab(Opdualag)Experimental Treatment2 Interventions
Patients will be given one dose of Opdualag (Nivolumab 480 mg IV + Relatlimab160 mg IV), prior to standard of care surgery for tumor resection.
Group II: Pre-Surgery Nivolumab + IpilimumabExperimental Treatment3 Interventions
Patients will be given one dose of Nivolumab (1mg/kg IV) and Ipilimumab (3mg/kg IV) prior to standard of care surgery for tumor resection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~3140
Nivolumab
2014
Completed Phase 3
~5220
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
561 Previous Clinical Trials
144,665 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,681 Previous Clinical Trials
4,124,997 Total Patients Enrolled
Yolanda Pina, MDPrincipal InvestigatorMoffitt Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Pre-Surgery Nivolumab + Relatlimab(Opdualag)
- Group 2: Pre-Surgery Nivolumab + Ipilimumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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