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Treatment Study for Patients with Newly-Diagnosed Stage III or IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Clinical Trial Title: 
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.
Clinical Trial Protocol ID: 
16090109
Clinical Trial Investigator Name: 
Summer B. Dewdney, MD
Clinical Trial Protocol Description: 

The purpose of this study is to research the effects of atezolizumab on ovarian, fallopian tube or primary peritoneal cancer. Atezolizumab may help the immune system to stop or reverse the growth of tumors. Subjects will receive treatment with paclitaxel, carboplatin and bevacizumab. These chemotherapy based treatments are standard care for the cancers being studied. In addition to these standard treatments, subjects will receive either atezolizumab or a placebo (an inactive substance that looks like atezolizumab). Subjects will continue study treatment until their disease no longer responds to the treatment, side effects prevent further treatment or 22 cycles are completed.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Have a histologic diagnosis of epithelial ovarian cancer (EOC), peritoneal primary carcinoma or fallopian tube cancer.

You will be excluded from the study if any of the following criteria apply to you:

  • Have received a current diagnosis of borderline epithelial ovarian tumor (formerly tumors of low malignant potential).
  • Have recurrent invasive epithelial ovarian, fallopian tube or primary peritoneal cancer that was treated only with surgery (e.g., participants with stage IA or stage IB epithelial ovarian or fallopian tube cancers).
  • Have non-epithelial ovarian tumors (e.g., germ cell tumors, sex cord stromal tumors).
  • Have received prior radiotherapy to any portion of the abdominal cavity or pelvis.
  • Have received prior chemotherapy for any abdominal or pelvic tumor that include neoadjuvant chemotherapy (NACT) for ovarian, primary peritoneal or fallopian tube cancer.
  • Have received any biological and/or targeted therapy (including but not limited to vaccines, antibodies, tyrosine kinase inhibitors) or hormonal therapy for management and/or treatment of epithelial ovarian or peritoneal primary cancer.

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Gynecologic Cancers
Contact Phone: 
(312) 942-2417 or (312) 942-7254
Contact Name: 
Lois Winkelman or Judith Dybinski