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 Randomized, Phase 3, Double-Blind Study of Chemoradiotherapy With or Without Pembrolizumab for the Treatment of High-risk, Locally Advanced Cervical Cancer (KEYNOTE-A18 / ENGOT-cx11)

    Cancer Categories
    • Gynecologic
    Karmanos Trial ID
    • GOG-3047
    NCT ID
    • NCT04221945
    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
    • John
      Wallbillich, M.D.

      Oncology - Gynecologic, Oncology - Surgical View Profile

    Objective:

    Primary
    • To compare concurrent chemoradiotherapy plus pembrolizumab with concurrent chemoradiotherapy plus placebo with respect to progression-free survival per RECIST 1.1 as assessed by blinded independent central review or by histopathologic confirmation of suspected local disease progression (in the absence of radiographic disease progression per RECIST 1.1)
    • To compare concurrent chemoradiotherapy plus pembrolizumab with concurrent chemoradiotherapy plus placebo with respect to overall survival
    Secondary
    • To compare concurrent chemoradiotherapy plus pembrolizumab with concurrent chemoradiotherapy plus placebo with respect to progression-free survival at 2 years per RECIST 1.1 as assessed by blinded independent central review or by histopathologic confirmation of suspected local disease progression (in the absence of radiographic disease progression per RECIST 1.1)
    • To compare concurrent chemoradiotherapy plus pembrolizumab with concurrent chemoradiotherapy plus placebo with respect to overall survival at 3 years
    • To compare concurrent chemoradiotherapy plus pembrolizumab with concurrent chemoradiotherapy plus placebo with respect to complete response rate at 12 weeks after concurrent chemoradiotherapy per RECIST 1.1 as assessed by blinded independent central review in all randomly assigned participants with measurable disease at study entry
    • To compare concurrent chemoradiotherapy plus pembrolizumab with concurrent chemoradiotherapy plus placebo with respect to objective response rate per RECIST 1.1 as assessed by blinded independent central review in all randomly assigned participants with measurable disease at study entry
    • To compare concurrent chemoradiotherapy plus pembrolizumab with concurrent chemoradiotherapy plus placebo with respect to overall survival and progression-free survival per RECIST 1.1 as assessed by blinded independent central review or by histopathologic confirmation of suspected local disease progression (in the absence of radiographic disease progression per RECIST 1.1), by PD-L1 status (by combined positivity score)
    • To compare concurrent chemoradiotherapy plus pembrolizumab with concurrent chemoradiotherapy plus placebo with respect to progression-free survival after next-line treatment (progression-free survival 2) following discontinuation of study treatment administration as determined by the investigator according to the local standard of clinical practice
    • To compare concurrent chemoradiotherapy plus pembrolizumab with concurrent chemoradiotherapy plus placebo with respect to change from baseline score in global quality of life and physical function using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) global health status/Quality of Life scale and Physical Function subscale
    • To compare concurrent chemoradiotherapy plus pembrolizumab with concurrent chemoradiotherapy plus placebo with respect to change from baseline score in symptom experience using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (Symptom Score for Cervical Cancer) the EORTC CX24 symptom specific scale (11 items)
    • To evaluate the safety and tolerability of pembrolizumab in combination with concurrent chemoradiotherapy
  • Locations

    Locations

    Karmanos Cancer Institute - Detroit Headquarters

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

    Karmanos Cancer Institute at Lawrence and Idell Weisberg Cancer Treatment Center - Farmington Hills

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