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Protocol No. GOG3015

Principal Investigator Barroilhet, Lisa

Phase III

Age Group Adult

Scope National

Sponsor Type Industry

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 Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Objective The purpose of this study is to research the effects, good or bad, of atezolizumab on your specific type of cancer (ovarian, fallopian tube, or primary peritoneal).

Treatment Atezolizumab is a type of drug called a programmed death−ligand 1 (PD-L1) antagonist. It is an experimental drug, which means that the health authorities have not approved atezolizumab for the treatment of your specific type of cancer. Atezolizumab is an antibody that affects your immune system by blocking the PD-L1 pathway. By blocking the PD-L1 pathway, atezolizumab may help your immune system to stop or reverse the growth of tumors. In this study, you will also receive treatment with paclitaxel, carboplatin, and bevacizumab. These chemotherapy-based treatments are standard for patients with your specific type of cancer. In addition to these standard treatments, you will receive either atezolizumab or a placebo (in other words, an inactive substance that looks like atezolizumab).

Description You will be randomly assigned by a computer program to standard treatment with one of the following treatment groups: atezolizumab or placebo. When you are "randomized" into the study, this means you are put into a group by chance (like tossing a coin). You will have an equal, 1 in 2 chance of being placed in any group. Neither you nor your study doctor will know which treatment you receive. You will also receive paclitaxel, carboplatin, and bevacizumab treatment regardless whether you are assigned to the atezolizumab or placebo treatment group. All study drugs will be administered directly into your blood stream by injection with a needle into a blood vessel (intravenous [IV] infusion) to allow for the medication to slowly enter your body.

Key Eligibility
  • Age ≥ 18 years
  • Receive a histologic diagnosis of epithelial ovarian cancer, peritoneal primary carcinoma, or fallopian tube cancer
  • For patients who receive therapeutic anticoagulation: stable anticoagulant regimen
  • For women of childbearing potential: agreement to remain abstinent or use a contraceptive method with a failure rate of < 1% per year during the treatment period and for at least 5 months after administration of the last dose of atezolizumab and 6 months after the last dose of bevacizumab, paclitaxel, or carboplatin, whichever is later
  • Patients who have a current diagnosis of borderline epithelial ovarian tumor (formerly tumors of low malignant potential) are excluded
  • Patients who have recurrent invasive epithelial ovarian, fallopian tube, or primary peritoneal cancer that was treated only with surgery (e.g., patients with Stage IA or Stage IB epithelial ovarian or fallopian tube cancers) are ineligible
  • Patients who have non-epithelial ovarian tumors (e.g., germ cell tumors, sex cord stromal tumors) are ineligible
  • Patients who received prior radiotherapy to any portion of the abdominal cavity or pelvis are ineligible
  • Patients who received prior chemotherapy for any abdominal or pelvic tumor are ineligible
  • Patients who are pregnant, lactating, or intend to become pregnant during the study are ineligible
  • Patients have an active or history of autoimmune disease or immune deficiency are ineligible
  • Patients who have a positive test result for HIV, active hepatitis B virus (HBV) infection, or hepatitis C virus (HCV) infection are ineligible
  • Patients who have had current or recent (within 10 days of randomization) use of aspirin (> 325 mg/day) or treatment with dipyramidole, ticlopidine, clopidogrel, and cilostazol are ineligible
  • Patients who have inadequately-controlled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure > 100 mmHg) are ineligible

Applicable Disease Sites Ovary

Therapies Involved Cytotoxic Chemotherapy

Drugs Involved Atezolizumab; Avastin (bevacizumab); MPDL3280A (Atezolizumab); bevacizumab; carboplatin; cbdca (carboplatin); paclitaxel; paraplatin (carboplatin); placebo; rhu Mab VEGF (bevacizumab); taxol (paclitaxel)

Status Open

Participating Institutions Aspirus Wausau Hospital, Aspirus Regional Cancer Center; UW Hospital and Clinics