A Study of Atezolizumab Versus Placebo in Combination With Paclitaxel, Carboplatin, and Bevacizumab in Participants With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Completed · Phase 3 · Has a placebo group

Conditions studied: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms

In brief

This is a Phase III, global, double-blind, 2-arm randomized study designed to compare the efficacy and safety of atezolizumab + paclitaxel + carboplatin + bevacizumab versus placebo + paclitaxel + carboplatin + bevacizumab. Study participants will have Stage 3 or 4 ovarian cancer (OC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) with macroscopic residual disease postoperatively (i.e., after primary tumor reductive surgery) or who will undergo neoadjuvant therapy followed by interval surgery.

Key facts

Study ID

NCT03038100

Run by

Hoffmann-La Roche

People needed

1301

Starts

2017-03-08

Expected to finish

2022-08-12

Last updated by the study team

2023-02-17

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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
• For participants who receive therapeutic anticoagulation: stable anticoagulant regimen
• Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen in paraffin blocks (preferred) or at least 20 unstained slides (for detailed tissue requirements at screening)

You may not qualify if…

• 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 (example [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)
• Received prior radiotherapy to any portion of the abdominal cavity or pelvis
• Received prior chemotherapy for any abdominal or pelvic tumor that include neoadjuvant chemotherapy (NACT) for ovarian, primary peritoneal or fallopian tube cancer
• 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
• Have synchronous primary endometrial cancer
• Have a prior history of primary endometrial cancer, except: Stage IA cancer; superficial myometrial invasion, without lymphovascular invasion; grade less than (<) 3 or poorly differentiated subtypes, and this includes papillary serous, clear cell or other International Federation of Gynecological Oncologists (FIGO) Grade 3 lesions
• With the exception of non-melanoma skin cancer and other specific malignancies as noted above, other invasive malignancies with any evidence of other cancers present within the last 5 years or previous cancer treatment that contraindicates this protocol therapy
• Have a known hypersensitivity or allergy to biopharmaceutical agents produced in Chinese hamster ovary cells or any component of the atezolizumab and/or bevacizumab formulations
• Undergo major surgical procedure within 28 days prior to first bevacizumab dose, or anticipation of the need for a major surgical procedure during the course of the study except participants who receive NACT and will need interval surgery. This may include but is not limited to laparotomy.
• Have prior allogeneic bone marrow transplantation or solid organ transplant
• Have any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results
• Have any approved or investigational anti-cancer therapy, including chemotherapy or hormonal therapy, with exceptions: Hormone-replacement therapy or oral contraceptives
• Are administered treatment with any other investigational agent or participation in another clinical study with anti-cancer therapeutic intent
• Have core biopsy or other minor surgical procedures within 7 days prior to the first dose of bevacizumab
• Have known sensitivity to any component of bevacizumab
• Have known sensitivity to any component of paclitaxel
• Current treatment with anti-viral therapy for hepatitis B virus (HBV)
• History of leptomeningeal disease

Where it is running

• Arizona Oncology Associates, PC - HAL — Scottsdale, Arizona, United States
• Arizona Oncology - HOPE Wilmot — Tucson, Arizona, United States
• Moores Cancer Center at UC San Diego Health — La Jolla, California, United States
• LAC + USC Medical Center — Los Angeles, California, United States
• UCLA - School of Medicine — Los Angeles, California, United States
• Kaiser Permanente - Oakland — Oakland, California, United States
• The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange — Orange, California, United States
• UC Irvine Medical Center — Orange, California, United States
• Stanford University — Palo Alto, California, United States
• Kaiser Permanente - Sacramento — Roseville, California, United States
• Southern California Kaiser Permanente — San Diego, California, United States
• California Pacific Medical Center Research Institute — San Francisco, California, United States
• K. Permanente - San Fransisco — San Francisco, California, United States
• University of California San Francisco Cancer Center — San Francisco, California, United States
• Kaiser Permanente - Santa Clara — Santa Clara, California, United States
• Olive View/Ucla Medical Center — Sylmar, California, United States
• Kaiser Permanente - Walnut Creek — Walnut Creek, California, United States
• University of Colorado Hospital - Anschutz Cancer Pavilion — Aurora, Colorado, United States
• Danbury Hospital — Danbury, Connecticut, United States
• Eastern Connecticut Hematology and Oncology Associates; (ECHO) — Norwich, Connecticut, United States
• Sylvester Comprehensive Cent. — Miami, Florida, United States
• Miami Cancer Institute of Baptist Health, Inc. — Miami, Florida, United States
• Sarasota Memorial Health Care System; Cancer Research Program — Sarasota, Florida, United States
• Women's Cancer Associates — St. Petersburg, Florida, United States
• St. Joseph'S Hospital & Medical Center — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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