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)

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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.


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
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Mount Vernon, Washington 98273
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1201 Camino de Salud Northeast
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1720 2nd Ave S
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185 Cambridge Street
Boston, Massachusetts 02114
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330 Brookline Ave
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5801 South Ellis Avenue
Chicago, Illinois 60637
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1900 W Polk St
Chicago, Illinois 60612
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9500 Euclid Avenue
Cleveland, Ohio 44106
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301 University Blvd
Galveston, Texas 77555
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2500 N State St
Jackson, Mississippi 39216
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4201 Belfort Road
Jacksonville, Florida 32216
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200 North Park Street
Kalamazoo, Michigan 49007
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
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Minneapolis, Minnesota 55455
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1211 Medical Center Dr
Nashville, Tennessee 37232
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600 8th Street South
Saint Petersburg, Florida 33701
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3900 W Avera Drive
Sioux Falls, South Dakota 57108
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Akron, Ohio 44304
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319 South Manning Boulevard
Albany, New York 12208
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Albuquerque, New Mexico 87109
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1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
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Austin, Texas 78731
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6701 N Charles St
Baltimore, Maryland 21204
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136 Mountainview Boulevard
Basking Ridge, New Jersey 07920
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801 Ostrum St
Bethlehem, Pennsylvania 18015
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Charlottesville, Virginia 22903
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1653 W. Congress Parkway
Chicago, Illinois 60612
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2600 Clifton Ave
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650 Commack Road
Commack, New York 11725
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Danbury, Connecticut 06810
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2300 N Edward St
Decatur, Illinois 62526
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Detroit, Michigan 48201
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
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501 N. Elam Avenue
Greensboro, North Carolina 27403
336-832-1100
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701 Grove Road
Greenville, South Carolina 29605
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92 2nd St
Hackensack, New Jersey 07601
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Harrison, New York 10604
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Houston, Texas 77030
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6550 Fannin St
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1515 Holcombe Blvd
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Indianapolis, Indiana 46237
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Indianapolis, Indiana 46260
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Indianapolis, Indiana 46202
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Irving, Texas 75063
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3535 Southern Blvd
Kettering, Ohio 45429
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La Jolla, California 92093
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Lansing, Michigan 48912
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