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 Ovarina, Fallopian Tube, or Primary Peritoneal Cancer.

Research & Trial Information


Protocol #: GOG-3015 Y039523

Cancer Type: GOG MISC.

Inclusion Criteria:

  1. Age ≥ 18 years.
  2. Receive a histologic diagnosis of EOC, peritoneal primary carcinoma, or fallopian tube cancer fulfilling the following criteria:

    All epithelial tumors of extra-uterine Müllerian origin by histology (FNA, cytology and/or cell block are not sufficient)

    For patients who will undergo primary tumor reductive surgery: International Federation of Gynecological Oncologists (FIGO) Stage III with gross (macroscopic or palpable) residual disease or Stage IV.

  3. Measurable disease on postoperative imaging studies is not required for eligibility

    FIGO stage is assessed following the completion of initial abdominopelvic surgery that provides the appropriate tissue for histologic evaluation and diagnosis and can be used for exploratory biomarker studies.

    Primary tumor reductive surgery must be within 42 days of randomization.

  4. For patients who will undergo neoadjuvant treatment and interval surgery: Patients who receive neoadjuvant treatment must also plan to undergo interval surgery after Cycle 3. Mandatory biopsy tissue samples (e.g., core needle or surgically obtained; FNA or cell-block from ascites and/or pleural effusion are inadequate) will be used to confirm histologically that the tumor is of extra-uterine Müllerian origin and to perform exploratory biomarker studies. Patients who receive neoadjuvant therapy will include those patients who are not deemed surgically resectable to a state of no gross residual disease due to the extent and/or distribution of disease (e.g., unresectable miliary pattern of peritoneal carcinomatosis, significant diaphragmatic disease, significant involvement of the root of the mesentery, diffuse tumor in the omentum up to the greater curvature of the stomach, extensive miliary carcinomatosis at the root of the mesentery, tumor infiltration of the stomach, surface lesions on the liver).
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  6. Life expectancy > 12 weeks.
  7. Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen (either archival specimen or fresh pretreatment tissue) in paraffin blocks (preferred) or at least 20 unstained slides.

Exclusion Criteria:

  1. Received a current diagnosis of borderline epithelial ovarian tumor (formerly tumors of low malignant potential).
  2. 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) Patients who received a prior diagnosis of a borderline tumor that was surgically resected and who subsequently developed an unrelated, new invasive epithelial ovarian, fallopian tube, or primary peritoneal cancer are eligible for enrollment, if they have never received prior chemotherapy for any ovarian tumor.
  3. Have non-epithelial ovarian tumors (e.g., germ cell tumors, sex cord stromal tumors).
  4. Received prior radiotherapy to any portion of the abdominal cavity or pelvis. Prior focal radiation for localized cancer of the breast, head and neck, or skin is permitted, if it was completed > 5 years prior to initiation of study treatment, and the patient remains free of recurrent or metastatic disease.
  5. Received prior chemotherapy for any abdominal or pelvic tumor that include NACT for ovarian, primary peritoneal or fallopian tube cancer. Patients may have received prior chemotherapy for localized breast cancer, if it was completed > 5 years prior to initiation of study treatment, and the patient remains free of recurrent or metastatic disease.
  6. 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.
  7. Have synchronous primary endometrial cancer.
  8. Have a prior history of primary endometrial cancer, except for the following:

    A prior diagnosis of endometrial cancer is allowed if all of the following conditions are met:

    Stage IA cancer

    Superficial myometrial invasion, without lymphovascular invasion

    Grade < 3 or not poorly differentiated subtypes, and this includes papillary serous, clear cell or other FIGO Grade 3 lesions.

  9. With the exception of non-melanoma skin cancer and other specific malignancies as noted above, other invasive malignancies within the last 5 years or previous cancer treatment that contraindicates this protocol therapy (e.g., previous chemotherapy treatment for breast cancer completed > 5 years ago is permitted as per above).
  10. Have a history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
  11. 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.
  12. Have an active or history of autoimmune disease or immune deficiency that includes but is not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener’s granulomatosis, Sjögren’s syndrome, Guillain-Barré syndrome, or multiple sclerosis.
  13. Have a history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis based on a screening chest computed tomography (CT) scan.
  14. Have a positive test result for HIV.
  15. Have active tuberculosis.
  16. Have severe infections within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
  17. Have received therapeutic oral or IV antibiotic medication within 2 weeks prior to initiation of study treatment, with the following exceptions:

    Patients who receive prophylactic antibiotic medication (e.g., urinary tract infection prophylaxis, prior to dental procedure) are eligible for enrollment.

  18. Have significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction, or cerebrovascular accident within 3 months prior to initiation of study treatment, unstable arrhythmias, or unstable angina.
  19. 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 patients who receive NACT and will need interval surgery



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