A Study of Atezolizumab Versus Placebo Given with Paclitaxel, Carboplatin, and Bevacizumab to Patients with Newly-Diagnosed Stage III/IV Ovarian, Fallopian Tube, Or Primary Peritoneal Cancer
- Conditions
- Ovarian cancer (OC), fallopian tube cancer (FTC), primary peritoneal cancer (PPC)MedDRA version: 20.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-003472-52-NO
- Lead Sponsor
- F. Hoffman-La Roche Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 1301
- Age >= 18 years
- Receive a histologic diagnosis of epithelial OC, FTC, or PPC fulfilling the following criteria: epithelial tumors histologically of Mullerian origin
- Patients with Stage III or Stage IV who have gross residual disease after primary surgery or who will undergo neoadjuvant treatment and planned interval surgery after Cycle 3
- Eastern Cooperative Oncology Group performance status of 0, 1, or 2
- Life expectancy > 12 weeks
- Adequate hematologic and end-organ function test results
- On a stable anticoagulant regimen, if therapeutic anticoagulation is indicated
- For women of childbearing potential: agreement to remain abstinent or use contraceptive methods that have a failure rate of < 1% per year during the treatment period and for at least 5 months after the last dose of study drug and 6 months after the last dose of Bev, Pac, or Carb, whichever is later
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, including all patient-reported outcomes questionnaires
- Availability of a representative formalin-fixed, paraffin-embedded tumor specimen (screening baseline tissue) in paraffin blocks or at least 20 unstained slides.
- For patient enrolled in the extended China enrollment phase: residents in Mainland China, residents in Hong Kong and Taiwan of Chinese ancestry and enrolled at sites recognized by China’s National Products Administration (NMPA).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 715
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 584
- Received a current diagnosis of borderline epithelial ovarian tumor
- Recurrent invasive epithelial ovarian, fallopian tube, or primary peritoneal cancer that was treated only with surgery
- Non-epithelial ovarian tumors
- Received prior radiotherapy to any portion of the abdomen or pelvis
- Received prior chemotherapy for any abdominal or pelvic tumor, including neoadjuvant chemotherapy for ovarian, primary peritoneal or fallopian tube cancer
- Received any hormonal, biological, and/or targeted therapy for epithelial ovarian, fallopian tube or primary peritoneal cancer
- Synchronous primary endometrial cancer
- Prior history of primary endometrial cancer, except if all of the mentioned conditions are met: Stage IA cancer, superficial myometrial invasion without lymphovascular invasion, and Grade < 3 or poorly differentiated subtypes which includes papillary serous, clear cell or other International Federation of Gynecological Oncologists 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
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis based on a screening chest computed tomography scan
- Known hypersensitivity or allergy to biopharmaceutical agents produced in Chinese hamster ovary cells or any component of the Atezo and/or Bev formulations
- 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, Sjogren’s syndrome, Guillain-Barré syndrome, or multiple sclerosis
- Active tuberculosis, positive test for HIV
- Significant cardiovascular disease (e.g., New York Heart Association cardiac disease, myocardial infarction infarction or cerebrovascular accident within 3 months before initiation of study treatment, unstable arrhythmias, or unstable angina)
- Inadequately-controlled hypertension
- Prior history of hypertensive crisis or hypertensive encephalopathy
- Administration of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment
- Current treatment with anti-viral therapy for HBV
- Prior allogeneic bone marrow transplantation or solid organ transplant
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-PD-1, anti-PD-L1, or anti-cytotoxic T-lymphocyte-associated protein 4 therapeutic antibodies
- Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to initiation of study treatment, systemic immunosuppressive medications within 2 weeks prior to initiation of study treatment
- History of hypertensive crisis or hypertensive encephalopathy, hemoptysis (Grade = 2) within 1 month prior to initiation of study treatment, abdominal fistula or gastrointestinal perforation within 6 months prior to initiation of study treatment
- Evidence of active bleeding, bleedi
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method