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A Phase 3 Trial of Fianlimab (REGN3767, Anti-Lag-3)+ Cemiplimab versus Pembrolizumab in Patients with Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma.

A Phase 3 Trial of Fianlimab (REGN3767, Anti-Lag-3)+ Cemiplimab versus Pembrolizumab in Patients with Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma.

  • Clinical Trial Information

    Trial Contact: Frankos, Marie; Caldwell, Chloe M; Donaldson, Karin M; Rodriguez Saavedra, Carlis M

  • IRB No: W22.061.03

    Protocol Abbrev: R3767-ONC-2011

    Principal Investigator: Sajeve Samuel Thomas, MD

    Phase: Drug: Phase III

    Age Group: Adult

    Secondary Protocol No: R3767-ONC-2011

    Treatment: Cemiplimab Fianlimab Pembrolizumab

    Therapies Involved: Chemotherapy

    ClinicalTrials.gov ID: NCT05352672

  • Objective

    Primary Objective
    •   To demonstrate superiority of fianlimab + cemiplimab compared
    to pembrolizumab, as measured by progression-free survival
    (PFS).

    Secondary Objectives
    •   To demonstrate superiority of fianlimab (REGN3767) +
    cemiplimab compared to pembrolizumab, as measured by overall
    survival (OS).
    •   To demonstrate superiority in ORR with fianlimab + cemiplimab
    compared to pembrolizumab.
    •   To characterize the objective response rate (ORR), PFS, and OS
    with fianlimab + cemiplimab compared to cemiplimab to inform
    the contribution of each components.
    •   To assess immunogenicity of fianlimab and cemiplimab.
    •   To assess impact of fianlimab + cemiplimab on physical
    functioning and role functioning and global health status/quality of
    life, as compared to pembrolizumab in adults.
    •   To characterize safety and tolerability of treatment in patients 12 to
    <18 years of age.
    •   To characterize ORR, PFS, and OS with treatment in patients 12 to
    <18 years of age.
    •   To assess the safety and tolerability of fianlimab + cemiplimab
    compared to pembrolizumab and to cemiplimab.
    •   To characterize pharmacokinetics (PK) of treatment using sparse
    PK sampling in patients aged ≥12 years.

  • Key Eligibility

    Inclusion:
    1. Age ≥12 years on the date of providing informed consent.
    Note: Patients who are <18 years will be included in the
    territories, where accepted, per local laws and regulations.
    2. A patient must have a valid LAG-3 immunohistochemistry
    (IHC) result, as determined by central testing, to be enrolled
    into the study. Any LAG-3 level (0-100% expression) will be
    allowed.
    3. Patients with histologically confirmed unresectable Stage III
    and Stage IV (metastatic) melanoma (AJCC, eighth revised
    edition) who have not received prior systemic therapy for
    advanced unresectable disease.
    a. Patients who received adjuvant and/or neoadjuvant systemic
    therapies are eligible if they did not have evidence of
    progression or recurrence of disease and/or discontinued due
    to occurrence of unmanageable irAEs ≥ grade 3 while on such
    therapies. Also, patients must have had a treatment-free and
    disease-free interval of >6 months.
    b. Patients with acral and mucosal melanomas are eligible.
    Accrual will be limited to approximately 10% of the total
    population.
    4. Measurable disease per RECIST v1.1
    a. Previously irradiated lesions can only be counted as target
    lesions if they have been demonstrated to progress and no
    other target lesion is available
    b. Cutaneous lesions should be evaluated as non-target lesions.
    5. Performance status:
    a) For adult patients: Eastern Cooperative Oncology Group
    (ECOG) performance status (PS) 0 or 1
    b) For pediatric patients: Karnofsky performance status ≥70
    (patients ≥16 years) or Lansky performance status ≥70
    (patients <16 years)
    6. Anticipated life expectancy of at least 3 months.