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
213
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2352
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Richmond, VA
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
1184
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
2072
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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1900 W Polk St
Chicago, Illinois 60612
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Chicago, IL
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
2024
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Cleveland, OH
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301 University Blvd
Galveston, Texas 77555
(409) 772-1011
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
1935
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Galveston, TX
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
1983
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Jackson, MS
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4201 Belfort Road
Jacksonville, Florida 32216
(408) 293-2336
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
2459
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200 North Park Street
Kalamazoo, Michigan 49007
(269) 382-2500
West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
1814
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Kalamazoo, MI
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
962
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Los Angeles, CA
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Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
1393
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
1971
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600 8th Street South
Saint Petersburg, Florida 33701
2527
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3900 W Avera Drive
Sioux Falls, South Dakota 57108
(605) 322-4700
Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
1264
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Akron, Ohio 44304
2042
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319 South Manning Boulevard
Albany, New York 12208
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Albuquerque, New Mexico 87109
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Albuquerque, New Mexico 87106
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Ann Arbor, Michigan 48197
1909
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1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
(404) 851-8000
Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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1026
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Austin, Texas 78731
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6701 N Charles St
Baltimore, Maryland 21204
(443) 849-2000
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9103 Franklin Square Drive
Baltimore, Maryland 21237
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2401 W Belvedere Ave
Baltimore, Maryland 21215
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136 Mountainview Boulevard
Basking Ridge, New Jersey 07920
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Baton Rouge, Louisiana 70815
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Bedford, Texas 76022
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1611 Anne Street Northwest
Bemidji, Minnesota 56601
1272
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801 Ostrum St
Bethlehem, Pennsylvania 18015
(484) 526-4000
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Billings, Montana 59101
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2603 East Broadway Avenue
Bismarck, North Dakota 58501
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1 Cooper Plaza
Camden, New Jersey 08103
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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Charlotte, North Carolina 28211
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200 Hawthorne Lane
Charlotte, North Carolina 28204
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Charlottesville, Virginia 22903
(434) 924-0311
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-1000
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18200 Lorain Avenue
Cleveland, Ohio 44111
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Columbus, Ohio 43215
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410 West 10th Avenue
Columbus, Ohio 43210
2006
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650 Commack Road
Commack, New York 11725
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5323 Harry Hines Boulevard
Dallas, Texas 75390
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Dallas, Texas 75390
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Danbury, Connecticut 06810
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2300 N Edward St
Decatur, Illinois 62526
(217) 876-8121
Decatur Memorial Hospital An American flag bearing only 48 stars waved above Decatur Memorial Hospital...
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300 East Locust Street
Des Moines, Iowa 50309
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Detroit, Michigan 48201
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2799 W Grand Blvd
Detroit, Michigan 48202
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Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Durham, North Carolina 27708
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509 Idlewild Avenue
Easton, Maryland 21601
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20 Medical Village Drive
Edgewood, Kentucky 41017
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8503 Arlington Blvd., Ste. 400
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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Fargo, North Dakota 58122
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302 Kensington Avenue
Flint, Michigan 48503
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Fort Wayne, Indiana 46805
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Fort Worth, Texas 76104
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400 West 7th Street
Frederick, Maryland 21701
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835 S Van Buren St
Green Bay, Wisconsin 54307
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Green Bay, Wisconsin 54311
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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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Greenville, South Carolina 29601
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92 2nd St
Hackensack, New Jersey 07601
(201) 996-5900
John Theurer Cancer Center at the Hackensack University Medical Center The mission of the John...
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500 Westchester Avenue
Harrison, New York 10604
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Hinsdale, Illinois 60521
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1319 Punahou Street
Honolulu, Hawaii 96826
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1301 Punchbowl Street
Honolulu, Hawaii 96813
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Houston, Texas 77030
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6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, Texas 77070
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8111 South Emerson Avenue
Indianapolis, Indiana 46237
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8402 Harcourt Road
Indianapolis, Indiana 46260
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535 Barnhill Drive
Indianapolis, Indiana 46202
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1557
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Iowa City, IA
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7415 Las Colinas Boulevard
Irving, Texas 75063
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Jackson, Mississippi 32916
1984
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3535 Southern Blvd
Kettering, Ohio 45429
(937) 298-4331
Kettering Medical Center Our flagship hospital, Kettering Medical Center, stands proudly in Kettering, Ohio. From...
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Knoxville, Tennessee 37920
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3855 Health Sciences Drive
La Jolla, California 92093
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Lake Success, New York
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1215 E Michigan Ave
Lansing, Michigan 48912
(517) 364-1000
Sparrow Hospital Sparrow has grown to become the region's largest health system, and its diverse...
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Las Cruces, New Mexico 88011
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