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, controlled study to evaluate the efficacy and safety of petosemtamab compared with investigator's choice monotherapy treatment in previously treated patients with incurable, metastatic/recurrent head and neck squamous cell carcinoma

    Cancer Categories
    • Head and Neck
    Karmanos Trial ID
    • 2024-023
    NCT ID
    • NCT06496178
    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
    • Tarik
      Hadid, M.D., MPH, MS, FACP

      Oncology - Medical View Profile

    Objective:

    Primary Objectives:

    • To compare antitumor activity in ORR per
      Response Evaluation Criteria in Solid Tumor
      (RECIST) Guidelines version (v) 1.1 as assessed
      by blinded independent central review (BICR)
      in patients with incurable metastatic /
      recurrent HNSCC patients progressed on after
      anti-PD-1 and platinum containing therapy,
      treated with petosemtamab monotherapy vs
      investigator’s choice monotherapy
    • To compare OS in patients with incurable
      metastatic / recurrent HNSCC progressed on
      after anti-PD-1 and platinum-containing
      therapy, treated with petosemtamab
      monotherapy vs investigator’s choice
      monotherapy

    Secondary Objectives:

    • To evaluate antitumor activity in ORR per
      RECIST v1.1 as assessed by investigator review
    • To evaluate antitumor activity in DOR per
      RECIST v1.1 as assessed by BICR and
      investigator review
    • To evaluate antitumor activity in TTR per
      RECIST v1.1 as assessed by BICR and
      investigator review
    • To evaluate antitumor activity in PFS per
      RECIST v1.1 as assessed by BICR and by
      investigator review
    • To evaluate antitumor activity in CBR per
      RECIST v1.1 as assessed by BICR and by
      investigator review
    • To evaluate safety and tolerability of
      petosemtamab monotherapy
    • To evaluate patient health-related quality of
      life (HRQL) using the European Organisation
      for Research and Treatment of Cancer (EORTC)
      validated Quality of Life of Cancer Patients
      Questionnaire (QLQ-C30)
    • To evaluate patient HRQL using the updated
      EORTC validated Quality of Life of Head and
      Neck Cancer Patients Questionnaire (QLQH&N43)
    • To characterize the PK of petosemtamab
    • To characterize the population PK of
      petosemtamab
    • To characterize the immunogenicity of
      petosemtamab
  • Locations

    Locations

    Karmanos Cancer Institute - Detroit Headquarters

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

    Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

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