Study on PD-1 Antibody Therapy and Infliximab for Treating Metastatic Melanoma

Sponsor: Massachusetts General Hospital

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05034536

Provider View

This clinical trial is testing a new combination of treatments using PD-1 antibody therapy, with or without LAG-3 inhibition, and infliximab to see if it is safe and effective for patients with metastatic melanoma.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of combining PD-1 antibody therapy (pembrolizumab or nivolumab+relatlimab) with infliximab for treating metastatic melanoma. While infliximab is not yet approved for melanoma, it is approved for other conditions. Pembrolizumab and nivolumab+relatlimab are approved for melanoma. This study aims to see if this combination can reduce side effects and improve the immune response against tumors.

Description

This study is a phase 2 clinical trial where participants will be randomly assigned to receive either PD-1 antibody therapy (pembrolizumab or nivolumab+relatlimab) with infliximab or with a placebo (a solution without medication). The trial is double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. The goal is to see if this combination can effectively manage metastatic or recurrent melanoma.

Pembrolizumab and nivolumab work by blocking a protein called PD-1, which helps the immune system recognize and attack cancer cells. Relatlimab blocks another protein, LAG-3, which can also help the immune system fight cancer. Infliximab is used to reduce inflammation and may help manage side effects related to immune responses.

Participants will receive the study treatment as long as their cancer does not worsen, they do not experience severe side effects, or they complete two years of therapy. The study will include follow-up visits to monitor participants' health and the treatment's effectiveness. Approximately 36 people will participate in this study, which is funded by The Bridge Project.

Eligibility Criteria

Inclusion Criteria

  • Be 18 years or older.
  • Have confirmed Stage III unresectable or Stage IV metastatic melanoma.
  • Be new to treatment and eligible for PD-1 or PD-1/LAG-3 therapy as the first treatment option.
  • Have measurable disease, meaning at least one tumor that can be accurately measured.
  • Have normal organ and bone marrow function based on specific blood tests.
  • Have a performance status score of 1 or less, indicating good overall health.
  • Be able to understand and sign a consent form agreeing to participate in the study.

Exclusion Criteria

  • Have ocular or mucosal melanoma.
  • Have been previously treated with certain antibodies for metastatic or unresectable melanoma.
  • Be receiving other cancer treatments.
  • Have untreated or symptomatic leptomeningeal disease.
  • Have an immune deficiency or be on high-dose steroids or other immunosuppressive drugs.
  • Have active autoimmune disease requiring treatment in the past two years.
  • Have a history of inflammatory bowel disease or certain types of colitis.
  • Be pregnant or breastfeeding.
  • Have uncontrolled illnesses or infections.
  • Have a history of severe heart disease or recent heart attack.
  • Have had another cancer within the past three years, except for certain skin or cervical cancers.
  • Have a history of hepatitis B or C, or certain infections.
  • Have received a live vaccine within 30 days before starting the study.
  • Have a known allergy to the study drugs or their components.

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