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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 below
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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:
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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 weeks
Treatment ~ Varies
Follow Up ~at 30 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 30 months for reporting.

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
2015
Completed Phase 3
~3070
Nivolumab
2015
Completed Phase 3
~4010

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
562 Previous Clinical Trials
144,832 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,682 Previous Clinical Trials
4,129,531 Total Patients Enrolled
Yolanda Pina, MDPrincipal InvestigatorMoffitt Cancer Center

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05704933 — Phase < 1
Brain Metastasis Research Study Groups: Pre-Surgery Nivolumab + Relatlimab(Opdualag), Pre-Surgery Nivolumab + Ipilimumab
Brain Metastasis Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT05704933 — Phase < 1
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05704933 — Phase < 1
~7 spots leftby Nov 2025
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