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 III, Randomized, Open-label Study to Evaluate Pembrolizumab as Neoadjuvant Therapy and in Combination With Standard of Care as Adjuvant Therapy for Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC)

    Cancer Categories
    • Head and Neck
    Karmanos Trial ID
    • 2017-157
    NCT ID
    • NCT03765918
    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:
    1. To compare the rate of major pathological response (mPR) as assessed by the central pathologist at the time of definitive surgery between participants who receive neoadjuvant therapy with pembrolizumab and participants who do not.
    2. To compare the EFS as assessed by BICR between participants who receive pembrolizumab neoadjuvant therapy and pembrolizumab with RT with or without cisplatin as adjuvant therapy and participants who receive only RT with or without cisplatin as adjuvant therapy.
    Secondary:
    1. To compare OS between participants who receive pembrolizumab neoadjuvant therapy and pembrolizumab with RT ± cisplatin as adjuvant therapy and participants who receive only RT ± cisplatin as adjuvant therapy.
    2. To evaluate the rate of pathological complete response (pCR) as assessed by the central pathologist at the time of definitive surgery.
    3. To evaluate global health status/quality of life (QoL) scores using the European Organisation for Research and Treatment of Cancer (EORTC) QoL questionnaire (QLQ) C30, and swallowing, speech and pain symptoms using the EORTC Head and Neck-Specific QoL questionnaire (EORTC QLQ-H&N35).
    4. To determine the safety and tolerability of pembrolizumab as neoadjuvant therapy and in combination with RT ± cisplatin as adjuvant therapy.
  • 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 Lawrence and Idell Weisberg Cancer Treatment Center - Farmington Hills

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