A Phase III Study Comparing Three Drug Regimens Using Liposomal Doxorubicin, Bevacizumab, and/or Atezolizumab Immunotherapy to Treat Recurrent or Persistent Ovarian Cancer

Full Title

NCTN: NRG-GY009: A Randomized, Phase II/III Study of Pegylated Liposomal Doxorubicin and CTEP-Supplied Atezolizumab (IND #134427) versus Pegylated Liposomal Doxorubicin/Bevacizumab and CTEP-Supplied Atezolizumab versus Pegylated Liposomal Doxorubicin/Bevacizumab in Platinum Resistant Ovarian Cancer (CIRB)

Purpose

Liposomal doxorubicin and bevacizumab are used to treat advanced ovarian cancer. In this study, researchers are evaluating the addition of the immunotherapy drug atezolizumab to standard chemotherapy to treat ovarian cancer that has continued to grow despite platinum-based chemotherapy.

Atezolizumab works by inhibiting a protein that puts the brakes on the immune response, unleashing the power of the immune system to detect and destroy cancer cells. It is used to treat bladder cancer and lung cancer; its use in this study is investigational. Patients will be randomly assigned to one of three treatments:

  • Liposomal doxorubicin plus bevacizumab
  • Liposomal doxorubicin plus atezolizumab
  • Liposomal doxorubicin, bevacizumab, and atezolizumab

All of these medications are given intravenously (by vein). Another purpose of this study is to learn if a biomarker test is helpful to decide whether or not a patient’s tumor has certain characteristics and will respond to study drug. Tissue from each patient’s prior surgery will be used for the biomarker test.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have advanced ovarian cancer that came back or continued to grow despite one or two prior regimens of therapy that included a platinum-containing drug.
  • At least 4 weeks must pass between the completion of previous treatment and entry into the study.
  • Patients may not have had prior bevacizumab after their ovarian cancer stopped responding to platinum-based therapy, nor immunotherapy or pelvic radiation therapy.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Roisin O’Cearbhaill at 646-888-4227.

Protocol

17-343

Phase

II/III

Investigator

Co-Investigators