Pilot Study of Nivolumab w/Ipilimumab or Relatlimab in Surgically Resectable Melanoma Brain Metastases

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT05704933
Phase
EARLY_PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Nivolumab is a monoclonal antibody o PD-1 protein, which is normally express on the surface of activated T cells. The interaction of PD-1 with its ligand (PD-L1) on T cells decreases their cytotoxic activity, helping protect normal cells in the setting of chronic inflammation. Tumor cells can utilize mechanisms to evade T cell mediated cytotoxicity by expressing PD-L1 on their surface or on the surface of T cells. Nivo, by blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2, allows T cells to remain active.
  • Ipilimumab — DRUG
    Ipilimumab is a recombinant, human antibody to CTLA-4.\[18-20\] CTLA-4 regulates T cell activation by binding with CD80 or CD86 with higher affinity than CD28, resulting in blockage of the co-stimulation signal and preventing further T cell activation. Blockade of CTLA-4 results in further T cell activation.
  • Nivolumab + Relatlimab — DRUG
    Opdualag (Nivolumab and Relatlimab-rmbw) is a human monoclonal antibody to LAG-3, currently under investigation.\[6\] Relatlimab is an antibody (IgG4 isotype) that has a stabilizing hinge mutation for attenuated Fc receptor binding to decrease or get rid of the possibility of antibody-mediated and/or complement-mediated target cell killing. Rela binds to an epitope on LAG-3 with high affinity and specificity, with subsequent blockade of LAG-3 and its interaction with its ligand, MHC class II. This antibody displays compelling in vitro functional activity in reversing LAG-3 that facilitates inhibition of an antigen-specific murine T cell hybridoma overexpressing human LAG-3 . Relatlimab was also shown to improve the activation of human T cells in superantigen stimulation assays when added either alone or in combination with Nivolumab.
  • Standard of Care Craniotomy — PROCEDURE
    Participants will undergo craniotomy for surgical resection of melanoma brain metastases.

Study Details

The purpose of this pilot study is to determine the safety and feasibility of giving a single dose of Nivolumab with Ipilimumab or Relatlimab in participants with brain metastases from melanoma who can undergo surgery for removal of their brain metastases 7- 10 days after receiving the study drug.

Key Dates

Start date
Jun 6, 2023
Status verified
Mar 2026
Primary completion
Jun 7, 2024
Completion
Aug 20, 2024

Study Design

Enrollment
1 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pre-Surgery Nivolumab + Ipilimumab
    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.
  • Experimental: Pre-Surgery Nivolumab + Relatlimab(Opdualag)
    Patients will be given one dose of Opdualag (Nivolumab 480 mg IV + Relatlimab160 mg IV), prior to standard of care surgery for tumor resection.

Primary Outcome Measure

Feasibility: Ability to recruit per treatment arm [ Time Frame: At 30 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612-
M.D. Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Tampa, FL

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Moffitt Cancer Center· Tampa, FLM.D. Anderson Cancer Center· Houston, TX

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