Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call 1-800-KARMANOS (1-800-527-6266) or request an appointment below
  • A Phase 3 Study of Fixed Dose Combinations of Fianlimab and Cemiplimab Versus Relatlimab and Nivolumab in Participants with Unresectable or Metastatic Melanoma

    Cancer Categories
    • Skin
    Karmanos Trial ID
    • 2024-044
    NCT ID
    • NCT06246916
    Age Group
    • Adult
    Scope
    • National
    PhaseClick for Clinical Trial Phase DefinitionPhase III
    Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug
    • Phase III
    Principal Investigator

    Objective:

    Primary Objectives:

    • To demonstrate superiority of Arm A (fianlimab + cemiplimab) compared to Arm B (Opdualag) as measured by ORR

    Secondary Objectives:

    • To describe PFS in Arm A and Arm B
    • To describe OS in Arm A and Arm B
    • To describe the duration of response (DOR) in Arm A and Arm B
    • To describe the disease control rate (DCR) in Arm A and Arm B
    • To describe ORR and PFS by investigator assessment in Arm A and Arm B
    • To assess the safety and tolerability of Arm A and Arm B
    • To characterize the pharmacokinetics (PK) of fianlimab and cemiplimab in Arm A
    • To assess the immunogenicity of fianlimab and cemiplimab
  • Locations

    Locations

    Karmanos Cancer Institute - Detroit Headquarters

    4100 John R
    Detroit, MI 48201
    Get Directions

    Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

    31995 Northwestern Hwy
    Farmington Hills, MI 48334
    Get Directions