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Study of Atezolizumab in patients with Ovarian, Fallopian Tube, or Primary Peritoneal Cancer


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
Therapeutic Area Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
Principal Investigator Young B. Kim, MD
Min Age 18 Years
Gender Female
Contact Jessika E Silva
617-636-8897
More Information http://clinicaltrials.gov/ct2/show/NCT03038100

Overview

In this study, subjects will also receive treatment with paclitaxel, carboplatin, and bevacizumab. These chemotherapy based treatments are standard for patients with ovarian, fallopian tube, or primary peritoneal cancer. In addition to these standard treatments, subjects will receive either atezolizumab or a placebo (in other words, an inactive substance that looks like atezolizumab).

Study Details

Inclusion Criteria

  • Participants receiving a histologic diagnosis of epithelial ovarian cancer (EOC), peritoneal primary carcinoma, or fallopian tube cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Life expectancy greater than (>) 12 weeks

Exclusion Criteria

  • 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 (example [e.g.], participants with Stage IA or Stage IB epithelial ovarian or fallopian tube cancers)
  • Received prior radiotherapy to any portion of the abdominal cavity or pelvis

Study Requirements

Participants of primary tumor-reductive surgery group will receive paclitaxel, carboplatin, atezolizumab intravenous (IV)/placebo infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab/placebo for a total of 22 cycles of atezolizumab/placebo and 21 cycles of bevacizumab. Participants of neoadjuvant therapy group will receive paclitaxel, carboplatin, bevacizumab (except for Cycle 3 and 4 when bevacizumab omitted peri-operatively), and atezolizumab IV/placebo infusion on Day 1 of each 21-day cycle for a total of 6 cycles followed by maintenance therapy bevacizumab with atezolizumab/placebo for a total of 22 cycles of atezolizumab/placebo and 20 cycles of bevacizumab. Study treatment will be discontinued at the time of disease progression, unacceptable toxicity, participant or physician decision to discontinue, death, or study termination.

Participants will also complete blood work, ECG, CT/MRI scans, and other procedures as required by protocol.