NCT05704933

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

A Randomized, Pilot Study to Evaluate the Molecular and Cellular Response to Treatment With Nivolumab With Either Adjuvant Ipilimumab or Relatlimab in Adult Patients With Surgically Resectable Melanoma Brain Metastases

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Metastatic Melanoma
• Metastasis to Brain

Interventions

Type	Name	Description
DRUG	Nivolumab	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.
DRUG	Ipilimumab	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.
DRUG	Nivolumab + Relatlimab	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.
PROCEDURE	Standard of Care Craniotomy	Participants will undergo craniotomy for surgical resection of melanoma brain metastases.

Timeline

• Start date: 2023-06-06
• Primary completion: 2024-06-07
• Completion: 2024-08-20
• First posted: 2023-01-30
• Last updated: 2026-04-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study