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 Open-Label, Randomized Study of PDS0101 Plus Pembrolizumab vs. Pembrolizumab Alone in First Line Treatment of Immune Checkpoint Inhibitor (ICI) Naïve Subjects with Unresectable Recurrent and/or Metastatic (R/M) Human Papillomavirus 16 (HPV16)-Related Head and Neck Squamous Cell Carcinoma (HNSCC)

    Cancer Categories
    • Head and Neck
    Karmanos Trial ID
    • 2025-016
    NCT ID
    • NCT06790966
    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 Objective:

    • The primary objective of the study is to compare OS between subjects who receive PDS0101 plus pembrolizumab (investigational arm) and those who receive pembrolizumab alone (control arm).

    Secondary Efficacy Objectives

    • To compare objective response rate (ORR) between the investigational arm vs control arm
    • To compare disease control rate (DCR) between investigational arm vs control arm
    • To compare duration of response (DOR) between the investigational arm vs control arm
    • To compare progression free survival (PFS) between the investigational arm vs control arm
  • Locations

    Locations

    Karmanos Cancer Institute - Detroit Headquarters

    4100 John R
    Detroit, MI 48201
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    Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

    31995 Northwestern Hwy
    Farmington Hills, MI 48334
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