A Study of Nivolumab and Relatlimab Immunotherapy Given Before and After Surgery in People with Advanced Melanoma

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Full Title

A Multicenter Study with Neoadjuvant and Adjuvant Checkpoint Blockade in Patients with Clinical Stage III or Oligometastatic Stage IV Melanoma

Purpose

Nivolumab immunotherapy is already used to treat advanced melanoma. In this study, researchers are evaluating the combination of nivolumab plus the investigational immunotherapy drug relatlimab when given before and after surgery in patients with advanced melanoma.

Nivolumab and relatlimab both boost the immune system’s ability to find and kill cancer cells. Nivolumab blocks the protein PD-1 and relatlimab blocks the protein LAG-3. PD-1 and LAG-3 usually act like two sets of “brakes” on the immune system. Blocking these proteins releases the brakes so the immune system can target and destroy cancer cells more effectively.

The researchers think that giving nivolumab and relatlimab together, before and after surgery, may be a more effective way to treat melanoma. Both medications are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have stage IIIB/C or stage IV melanoma that has spread to three or fewer sites and is surgically removable.
  • At least 4 weeks must pass between completion of prior treatment and entry into the study.
  • Patients may not have been previously treated with certain immunotherapy drugs, such as pembrolizumab, nivolumab, and ipilimumab.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

To have an evaluation to determine eligibility for this study, please call 646-497-9067 to make an appointment with a member of our melanoma team.

Protocol

19-223

Phase

II

Investigator

Co-Investigators

Diseases