A Phase III Study of Standard Chemotherapy plus Either Atezolizumab Immunotherapy or Placebo in Women Newly Diagnosed with Stage III or IV Ovarian Cancer

Full Title

YO39523/GOG-3015: A Phase III, Multicenter, Randomized, Study of Atezolizumab versus Placebo Administered in Combination with Paclitaxel, Carboplatin, and Bevacizumab to Patients with Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Purpose

Paclitaxel, carboplatin, and bevacizumab are standard chemotherapy drugs used to treat advanced ovarian cancer. In this study, researchers want to see if adding the immunotherapy drug atezolizumab to standard chemotherapy is more effective than standard chemotherapy alone in women newly diagnosed with stage III or IV ovarian, primary peritoneal, or fallopian tube cancer.

Atezolizumab is designed to improve the immune system’s ability to recognize and destroy cancer cells by blocking PD-L1, a protein made by some cancers. It is approved for treating bladder and lung cancers; its use in this study is considered investigational. Patients will be randomly assigned to one of two treatments:

  • Paclitaxel, carboplatin, bevacizumab, and atezolizumab, followed by atezolizumab plus bevacizumab
  • Paclitaxel, carboplatin, bevacizumab, and a placebo (inactive drug), followed by a placebo plus bevacizumab

All of these medications are given intravenously (by vein).

Eligibility

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

  • Patients must be newly diagnosed with stage III or IV ovarian, primary peritoneal, or fallopian tube cancer.
  • This study is open to both patients having surgery before chemotherapy as well as patients who have neoadjuvant chemotherapy (given before surgery).
  • Patients may not have previously received chemotherapy for their ovarian cancer.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for women age 19 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Carol Aghajanian at 646-888-4217.

Protocol

17-381

Phase

III

Investigator

Co-Investigators