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 II/III Study of Pegylated Liposomal Doxirubicin and CTEP-Supplied Atezolizumab (IND #134427) Versus Pegylated Liposomal Doxirubicin/Bevacizumab and CTEP-Supplied Atezolizumab Versus Pegylated Liposomal Doxirubicin/Bevacizumab in Platinu

    Cancer Categories
    • Gynecologic
    Karmanos Trial ID
    • NRG-GY009
    NCT ID
    • NCT02839707
    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/III
    Principal Investigator
    • Robert
      Morris, M.D.

      Oncology - Gynecologic, Oncology - Surgical View Profile

    Objective:

    Primary:
    • Safety Lead-in: Estimate the probability of a dose limiting toxicity (DLT) following cycle 1 of experimental regimens (PLD and atezolizumab and PLD/bevacizumab and atezolizumab).
    • Phase II Study: Estimate and compare the hazard of first progression or death (PFS) of each experimental regimen relative to the reference regimen, PLD and bevacizumab.
    • Phase III Study: Estimate and compare the hazard of death and the hazard of first progression or death (PFS) of each experimental regimen relative to the reference regimen. If the relative hazards of death (or the hazards of first progression or death) are significantly lower on both experimental regimens, then the hazards of death (the hazards of first progression or death) on the two experimental regimens will be compared to each other.
    Secondary:
    • Phase II Study-Secondary efficacy endpoints: Estimate and compare the probabilities of response rate (ORR, either partial or complete response) defined by RECIST v1.1 criteria on each study regimen.
    • Safety endpoint: Estimate the frequency and severity of adverse events as classified and graded with Common Terminology Criteria for Adverse Events (CTCAE) in those patients who initiate their randomly assigned study treatment (03/19/2018).
    • Phase III Study-Secondary efficacy endpoints: Estimate and compare ORR in each treatment group.
    • Safety endpoints: Estimate the frequency and severity of adverse events in those patients who initiate their randomly assigned study treatment.
    • Patient Reported outcomes (PRO): Estimate and compare mean patient reported outcome scores (PROs) as measured by NFOSI-18 Disease-related symptoms (DRS).
    • Exploratory endpoints: Estimate and compare the treatment groups on the basis of the PROs: Treatment Side Effects (TSE), Function/well-being (FWB), Fatigue (FACIT-Fatigue subscale) and Abdominal Discomfort (FACT/GOG-AD subscale) (10/16/2017).
  • 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