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
Status: | Recruiting |
---|---|
Conditions: | Ovarian Cancer, Cancer, Cancer, Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/4/2019 |
Start Date: | March 8, 2017 |
End Date: | December 1, 2021 |
Contact: | Reference Study ID Number: YO39523 www.roche.com/about_roche/roche_worldwide.htm |
Email: | global-roche-genentech-trials@gene.com |
Phone: | 888-662-6728 (U.S. and Canada) |
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
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.
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.
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
We found this trial at
213
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Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
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Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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1601 Trinity Street
Austin, Texas 78701
Austin, Texas 78701
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Greater Baltimore Medical Center The 255-bed medical center (acute and sub-acute care) is located on...
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Sinai Hospital of Baltimore Sinai Hospital of Baltimore provides a broad array of high-quality, cost-effective...
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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University Hospitals of Cleveland The history of University Hospitals Case Medical Center is linked to...
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5323 Harry Hines Boulevard
Dallas, Texas 75390
Dallas, Texas 75390
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Decatur Memorial Hospital An American flag bearing only 48 stars waved above Decatur Memorial Hospital...
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Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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20 Medical Village Drive
Edgewood, Kentucky 41017
Edgewood, Kentucky 41017
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8503 Arlington Blvd., Ste. 400
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Fairfax, Virginia 22031
(703) 280-5390
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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302 Kensington Avenue
Flint, Michigan 48503
Flint, Michigan 48503
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Cone Health Cancer Center Located adjacent to Wesley Long Hospital, our Cone Health Cancer Center...
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701 Grove Road
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92 2nd St
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John Theurer Cancer Center at the Hackensack University Medical Center The mission of the John...
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Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Kettering Medical Center Our flagship hospital, Kettering Medical Center, stands proudly in Kettering, Ohio. From...
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