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

a study on Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer

Summary

for females ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Lee-May Chen

Description

Summary

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.

Official 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

Keywords

Ovarian Cancer Fallopian Tube Cancer Peritoneal Neoplasms Fallopian Tube Neoplasms Paclitaxel Atezolizumab Albumin-Bound Paclitaxel Bevacizumab Carboplatin Antibodies, Monoclonal

Eligibility

You can join if…

Open to females ages 18 years and up

  • 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 CAN'T join 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

Locations

  • Zuckerberg San Francisco General Hospital in progress, not accepting new patients
    San Francisco California 94110 United States
  • University of California San Francisco Cancer Center accepting new patients
    San Francisco California 94158 United States
  • K. Permanente - San Fransisco accepting new patients
    San Francisco California 94115 United States
  • Kaiser Permanente - South San Francisco accepting new patients
    South San Francisco California 94080 United States
  • Kaiser Permanente - Oakland in progress, not accepting new patients
    Oakland California 94611 United States
  • Kaiser Permanente - San Leandro accepting new patients
    San Leandro California 94577 United States
  • Kaiser Permanente - Walnut Creek in progress, not accepting new patients
    Walnut Creek California 94596 United States
  • Stanford University accepting new patients
    Palo Alto California 94305 United States
  • Kaiser Permanente - Vallejo accepting new patients
    Vallejo California 94589 United States
  • Kaiser Permanente - Santa Clara in progress, not accepting new patients
    Santa Clara California 95051 United States
  • Stanford Cancer Center South Bay withdrawn
    San Jose California 95124 United States
  • Kaiser Permanente - San Jose accepting new patients
    San Jose California 95119 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT03038100
Phase
Phase 3
Lead Scientist
Lee-May Chen
Study Type
Interventional
Last Updated
May 31, 2018