Study of nivolumab and relatilimab for untreated melanoma patients

A Randomized, Double-blind Phase 2/3 Study of Relatlimab Combined with Nivolumab versus Nivolumab in Participants with Previously Untreated Metastatic or Unresectable Melanoma

September 18, 2018

  • Clinical Trial Information

    Trial Contact: Frankos, Marie; Tan, Ciara Natasha

    Trial Phone: 321.841.7303 ; 321.841.7413

  • IRB No: WIRB 20180567

    Protocol Abbrev: TRIO_CA224-047

    Principal Investigator: Sajeve Samuel Thomas, MD

    Phase: Drug: Phase II

    Age Group: Adult

    Secondary Protocol No: ca224-047

    Treatment: Nivolumab and Relatlimib

    Therapies Involved: Oncology: 1st line

    ClinicalTrials.gov ID: NCT03470922

  • Objective

    The purpose of this study is to determine whether Nivolumab in combination with Relatlimab is more effective than Nivolumab by itself in treating unresectable Melanoma or Melanoma that has spread

  • Key Eligibility

    Inclusion Criteria:
    •  Participants must have histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the AJCC staging system
    •  Participants must not have had prior systemic anticancer therapy for unresectable or metastatic melanoma
    •  Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses