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)

Use our guide to learn which trials are right for you!

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
sites
10990 San Diego Mission Road
San Diego, California 92108
?
mi
from
San Diego, CA
Click here to add this to my saved trials
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...
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
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...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
?
mi
from
Boston, MA
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
Click here to add this to my saved trials
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
?
mi
from
Boston, MA
Click here to add this to my saved trials
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...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
1900 W Polk St
Chicago, Illinois 60612
?
mi
from
Chicago, IL
Click here to add this to my saved trials
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
301 University Blvd
Galveston, Texas 77555
(409) 772-1011
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
?
mi
from
Galveston, TX
Click here to add this to my saved trials
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...
?
mi
from
Jackson, MS
Click here to add this to my saved trials
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...
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
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...
?
mi
from
Kalamazoo, MI
Click here to add this to my saved trials
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...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
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...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
600 8th Street South
Saint Petersburg, Florida 33701
?
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
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...
?
mi
from
Sioux Falls, SD
Click here to add this to my saved trials
Akron, Ohio 44304
?
mi
from
Akron, OH
Click here to add this to my saved trials
319 South Manning Boulevard
Albany, New York 12208
?
mi
from
Albany, NY
Click here to add this to my saved trials
Albuquerque, New Mexico 87109
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Albuquerque, New Mexico 87106
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Ann Arbor, Michigan 48197
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
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...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Austin, Texas 78731
?
mi
from
Austin, TX
Click here to add this to my saved trials
?
mi
from
Austin, TX
Click here to add this to my saved trials
6701 N Charles St
Baltimore, Maryland 21204
(443) 849-2000
Greater Baltimore Medical Center The 255-bed medical center (acute and sub-acute care) is located on...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
9103 Franklin Square Drive
Baltimore, Maryland 21237
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
2401 W Belvedere Ave
Baltimore, Maryland 21215
(410) 601-9000
Sinai Hospital of Baltimore Sinai Hospital of Baltimore provides a broad array of high-quality, cost-effective...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
136 Mountainview Boulevard
Basking Ridge, New Jersey 07920
?
mi
from
Basking Ridge, NJ
Click here to add this to my saved trials
Baton Rouge, Louisiana 70815
?
mi
from
Baton Rouge, LA
Click here to add this to my saved trials
Bedford, Texas 76022
?
mi
from
Bedford, TX
Click here to add this to my saved trials
1611 Anne Street Northwest
Bemidji, Minnesota 56601
?
mi
from
Bemidji, MN
Click here to add this to my saved trials
801 Ostrum St
Bethlehem, Pennsylvania 18015
(484) 526-4000
St Luke'S Hospital And Health Network St. Luke's University Health Network (SLUHN) is a nonprofit,...
?
mi
from
Bethlehem, PA
Click here to add this to my saved trials
Billings, Montana 59101
?
mi
from
Billings, MT
Click here to add this to my saved trials
2603 East Broadway Avenue
Bismarck, North Dakota 58501
?
mi
from
Bismarck, ND
Click here to add this to my saved trials
Boise, Idaho 83706
?
mi
from
Boise, ID
Click here to add this to my saved trials
Bozeman, Montana 59715
?
mi
from
Bozeman, MT
Click here to add this to my saved trials
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
1 Cooper Plaza
Camden, New Jersey 08103
?
mi
from
Camden, NJ
Click here to add this to my saved trials
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28211
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
200 Hawthorne Lane
Charlotte, North Carolina 28204
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Charlottesville, Virginia 22903
(434) 924-0311
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-1000
University Hospitals of Cleveland The history of University Hospitals Case Medical Center is linked to...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
18200 Lorain Avenue
Cleveland, Ohio 44111
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Columbus, Ohio 43215
?
mi
from
Columbus, OH
Click here to add this to my saved trials
410 West 10th Avenue
Columbus, Ohio 43210
?
mi
from
Columbus, OH
Click here to add this to my saved trials
650 Commack Road
Commack, New York 11725
?
mi
from
Commack, NY
Click here to add this to my saved trials
5323 Harry Hines Boulevard
Dallas, Texas 75390
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Dallas, Texas 75390
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Danbury, Connecticut 06810
?
mi
from
Danbury, CT
Click here to add this to my saved trials
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...
?
mi
from
Decatur, IL
Click here to add this to my saved trials
?
mi
from
Decatur, IL
Click here to add this to my saved trials
300 East Locust Street
Des Moines, Iowa 50309
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
Detroit, Michigan 48201
?
mi
from
Detroit, MI
Click here to add this to my saved trials
2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Durham, North Carolina 27708
?
mi
from
Durham, NC
Click here to add this to my saved trials
509 Idlewild Avenue
Easton, Maryland 21601
?
mi
from
Easton, MD
Click here to add this to my saved trials
20 Medical Village Drive
Edgewood, Kentucky 41017
?
mi
from
Edgewood, KY
Click here to add this to my saved trials
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...
?
mi
from
Fairfax, VA
Click here to add this to my saved trials
Fargo, North Dakota 58122
?
mi
from
Fargo, ND
Click here to add this to my saved trials
302 Kensington Avenue
Flint, Michigan 48503
?
mi
from
Flint, MI
Click here to add this to my saved trials
Flushing, New York 11355
?
mi
from
Flushing, NY
Click here to add this to my saved trials
Fort Wayne, Indiana 46805
?
mi
from
Fort Wayne, IN
Click here to add this to my saved trials
Fort Worth, Texas 76104
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
400 West 7th Street
Frederick, Maryland 21701
?
mi
from
Frederick, MD
Click here to add this to my saved trials
?
mi
from
Gainesville, GA
Click here to add this to my saved trials
?
mi
from
Geneva, IL
Click here to add this to my saved trials
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
835 S Van Buren St
Green Bay, Wisconsin 54307
?
mi
from
Green Bay, WI
Click here to add this to my saved trials
Green Bay, Wisconsin 54311
?
mi
from
Green Bay, WI
Click here to add this to my saved trials
501 N. Elam Avenue
Greensboro, North Carolina 27403
336-832-1100
Cone Health Cancer Center Located adjacent to Wesley Long Hospital, our Cone Health Cancer Center...
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
701 Grove Road
Greenville, South Carolina 29605
?
mi
from
Greenville, SC
Click here to add this to my saved trials
Greenville, South Carolina 29601
?
mi
from
Greenville, SC
Click here to add this to my saved trials
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...
?
mi
from
Hackensack, NJ
Click here to add this to my saved trials
500 Westchester Avenue
Harrison, New York 10604
?
mi
from
Harrison, NY
Click here to add this to my saved trials
Hinsdale, Illinois 60521
?
mi
from
Hinsdale, IL
Click here to add this to my saved trials
1319 Punahou Street
Honolulu, Hawaii 96826
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
1301 Punchbowl Street
Honolulu, Hawaii 96813
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
?
mi
from
Houston, TX
Click here to add this to my saved trials
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...
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77070
?
mi
from
Houston, TX
Click here to add this to my saved trials
8111 South Emerson Avenue
Indianapolis, Indiana 46237
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
8402 Harcourt Road
Indianapolis, Indiana 46260
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
535 Barnhill Drive
Indianapolis, Indiana 46202
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
7415 Las Colinas Boulevard
Irving, Texas 75063
?
mi
from
Irving, TX
Click here to add this to my saved trials
Jackson, Mississippi 32916
?
mi
from
Jackson, MS
Click here to add this to my saved trials
3535 Southern Blvd
Kettering, Ohio 45429
(937) 298-4331
Kettering Medical Center Our flagship hospital, Kettering Medical Center, stands proudly in Kettering, Ohio. From...
?
mi
from
Kettering, OH
Click here to add this to my saved trials
Knoxville, Tennessee 37920
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
3855 Health Sciences Drive
La Jolla, California 92093
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
Lake Success, New York
?
mi
from
Lake Success, NY
Click here to add this to my saved trials
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...
?
mi
from
Lansing, MI
Click here to add this to my saved trials
Las Cruces, New Mexico 88011
?
mi
from
Las Cruces, NM
Click here to add this to my saved trials