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 2, Randomized, Open-label, Three-arm Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK7902) in Combination with Pembrolizumab (MK3475) versus Standard of Care Chemotherapy and Lenvatinib Monotherapy in Participants with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) that have Progressed after Platinum Therapy and Immunotherapy (PD1/PDL1 Inhibitors) (LEAP009)

    Cancer Categories
    • Head and Neck
    Karmanos Trial ID
    • 2020-062
    NCT ID
    • NCT04428151
    Age Group
    • Adult
    Scope
    • National
    PhaseClick for Clinical Trial Phase DefinitionPhase II
    Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks.
    • Phase II
    Principal Investigator

    Objective:

    Primary Objective:
    • to compare pembrolizumab + lenvatinib combination therapy and SOC chemotherapy with respect to ORR per RECIST 1.1 as assessed by BICR.
    Secondary Objectives:
    • to compare pembrolizumab + lenvatinib combination therapy and SOC chemotherapy with respect to PFS per RECIST 1.1 by BICR.
    • to compare pembrolizumab + lenvatinib combination therapy and SOC chemotherapy with respect to OS.
    • to assess the efficacy of pembrolizumab + lenvatinib combination therapy and SOC chemotherapy with respect to DOR per RECIST 1.1, by BICR.
    • to assess the safety and tolerability of study intervention with pembrolizumab + lenvatinib combination therapy, SOC chemotherapy, and lenvatinib monotherapy
  • Locations

    Locations

    Karmanos Cancer Institute - Detroit Headquarters

    4100 John R
    Detroit, MI 48201
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    Phone: 800-527-6266

    Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

    31995 Northwestern Hwy
    Farmington Hills, MI 48334
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    Phone: 800-527-6266