A Study of Atezolizumab as Adjuvant Therapy in Participants With Renal Cell Carcinoma (RCC) at High Risk of Developing Metastasis Following Nephrectomy



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/22/2019
Start Date:January 3, 2017
End Date:April 13, 2024
Contact:Reference Study ID Number: WO39210 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, Placebo-Controlled, Double-Blind Study of Atezolizumab (Anti−PD-L1 Antibody) as Adjuvant Therapy in Patients With Renal Cell Carcinoma at High Risk of Developing Metastasis Following Nephrectomy

This is a Phase III, multicenter, randomized, placebo-controlled, double-blind study to
evaluate the efficacy and safety of atezolizumab versus placebo in participants with RCC who
are at high risk of disease recurrence following nephrectomy.


Inclusion Criteria:

- ECOG performance status of less than or equal to (
- Pathologically confirmed RCC with a component of either clear cell histology or
sarcomatoid histology that has not been previously treated in the adjuvant or
neoadjuvant setting and classified as being at high risk of RCC recurrence

- Radical or partial nephrectomy with lymphadenectomy in select participants

- Absence of residual disease and absence of metastasis, as confirmed by a negative
baseline computed tomography (CT) of the pelvis, abdomen, and chest no more than 4
weeks prior to randomization. Confirmation of disease-free status will be assessed by
an independent central radiologic review of imaging data.

- Absence of brain metastasis, as confirmed by a negative CT with contrast or magnetic
resonance imaging (MRI) scan of the brain, no more than 4 weeks prior to
randomization. Applicable only to metastasectomy participants

- Full recovery from nephrectomy or metastasectomy within 12 weeks from randomization
following surgery

Exclusion Criteria:

- Bilateral synchronous tumors with inheritable forms of RCC including von Hippel-Lindau

- Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3
weeks prior to initiation of study treatment

- Treatment with any other investigational agent or participation in another clinical
study with therapeutic intent within 28 days or five half-lives of the investigational
agent, whichever is longer, prior to enrollment

- Malignancies other than RCC within 5 years prior to Cycle 1, Day 1

- History of autoimmune disease

- Participants with prior allogeneic stem cell or solid organ transplantation

- History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced
pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic
organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan

- Positive test for HIV

- Participants with active hepatitis B or hepatitis C

- Active tuberculosis

- Severe infections within 4 weeks prior to randomization including but not limited to
hospitalization for complications of infection, bacteremia, or severe pneumonia

- Major surgical procedure within 4 weeks prior to randomization or anticipation of need
for a major surgical procedure during the course of the study other than for diagnosis

- Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1

- 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 or render the participant at high risk from treatment
complications

- Prior treatment with cluster of differentiation (CD)137 agonists, anti-cytotoxic
T-lymphocyte-associated protein-4 (anti-CTLA-4), anti-programmed death-1 (anti-PD−1),
or anti-programmed death-ligand 1 (anti-PD-L1) therapeutic antibody or
pathway-targeting agents

- Treatment with systemic immunostimulatory agents (including but not limited to
interferons or interleukin-2) within 6 weeks or five half-lives of the drug, whichever
is shorter, prior to randomization

- Treatment with systemic immunosuppressive medications (including but not limited to
corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and
anti−tumor necrosis factor agents) within 2 weeks prior to randomization or
anticipated need for systemic immunosuppressive medications during the study
We found this trial at
66
sites
?
mi
from
Fort Myers, FL
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
?
mi
from
Gainesville, FL
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
1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
?
mi
from
New York, NY
Click here to add this to my saved trials
825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
?
mi
from
Albany, NY
Click here to add this to my saved trials
Albany, New York 12206
?
mi
from
Albany, NY
Click here to add this to my saved trials
1365 Clifton Road
Atlanta, Georgia 30322
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Atlanta, Georgia 30322
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Aurora, Colorado 80045
?
mi
from
Aurora, CO
Click here to add this to my saved trials
1442 Avenida Maipú
Buenos Aires,
?
mi
from
Buenos Aires,
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
Chattanooga, Tennessee 37403
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
9500 Euclid Avenue
Cleveland, Ohio 44195
?
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
1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Denver, Colorado 80211
?
mi
from
Denver, CO
Click here to add this to my saved trials
1500 East Duarte Road
Duarte, California 91010
626-256-HOPE (4673)
City of Hope National Medical Center City of Hope is dedicated to making a difference...
?
mi
from
Duarte, CA
Click here to add this to my saved trials
Durham, North Carolina 27710
?
mi
from
Durham, NC
Click here to add this to my saved trials
Gilbert, Arizona 85234
?
mi
from
Gilbert, AZ
Click here to add this to my saved trials
Hershey, Pennsylvania 17033
?
mi
from
Hershey, PA
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
200 Hawkins Drive
Iowa City, Iowa 52242
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
Jacksonville, Florida 32216
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
2316 East Meyer Boulevard
Kansas City, Missouri 64132
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
822 Broad Street
Kingsport, Tennessee 37660
?
mi
from
Kingsport, 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
44151 15th Street West
Lancaster, California 93534
?
mi
from
Lancaster, CA
Click here to add this to my saved trials
Lancaster, Pennsylvania 17604
?
mi
from
Lancaster, PA
Click here to add this to my saved trials
201 South 68th Street Place
Lincoln, Nebraska 68510
?
mi
from
Lincoln, NE
Click here to add this to my saved trials
200 Medical Plaza Driveway
Los Angeles, California 90024
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Louisville, Kentucky 40207
?
mi
from
Louisville, KY
Click here to add this to my saved trials
6780 Mayfield Rd
Mayfield Heights, Ohio 44124
?
mi
from
Mayfield Heights, OH
Click here to add this to my saved trials
?
mi
from
Maywood, IL
Click here to add this to my saved trials
1600 Northwest 10th Avenue
Miami, Florida 33136
?
mi
from
Miami, FL
Click here to add this to my saved trials
1 Medical Center Drive
Morgantown, West Virginia 26506
304-598-4800
West Virginia University Hospitals Inc. WVU Healthcare is two corporations, University Health Associates and WVU...
?
mi
from
Morgantown, WV
Click here to add this to my saved trials
823 82nd Parkway, Suite B
Myrtle Beach, South Carolina 29572
(843) 449-1010 ext.268
Carolina Urologic Research Center Carolina Urologic Research Center (CURC) has been recognized both nationally and...
?
mi
from
Myrtle Beach, SC
Click here to add this to my saved trials
1215 21st Avenue South
Nashville, Tennessee 37232
?
mi
from
Nashville, TN
Click here to add this to my saved trials
3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
New Haven, Connecticut 06520
?
mi
from
New Haven, CT
Click here to add this to my saved trials
New Orleans, Louisiana 70112
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
New Orleans, Louisiana 70121
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
?
mi
from
New York, NY
Click here to add this to my saved trials
New York, New York 10016
?
mi
from
New York, NY
Click here to add this to my saved trials
800 Northeast 10th Street
Oklahoma City, Oklahoma 73104
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
101 The City Drive South
Orange, California 92868
714-456-7890
University of California, Irvine Medical Center We are UC Irvine Health. We are a devoted...
?
mi
from
Orange, CA
Click here to add this to my saved trials
925 Chestnut Street
Philadelphia, Pennsylvania 19107
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
333 Cottman Avenue
Philadelphia, Pennsylvania 19111
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15232
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
?
mi
from
Portland, OR
Click here to add this to my saved trials
Rancho Cucamonga, California 91730
?
mi
from
Rancho Cucamonga, CA
Click here to add this to my saved trials
200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
?
mi
from
Rochester, MN
Click here to add this to my saved trials
601 Elmwood Avenue
Rochester, New York 14642
?
mi
from
Rochester, NY
Click here to add this to my saved trials
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
Scarborough, Maine 04074
?
mi
from
Scarborough, ME
Click here to add this to my saved trials
5777 E Mayo Blvd
Scottsdale, Arizona 85259
(480) 515-6296
Mayo Clinic Scottsdale Mayo Clinic Arizona was the second Mayo practice to be established outside...
?
mi
from
Scottsdale, AZ
Click here to add this to my saved trials
1309 West 17th Street
Sioux Falls, South Dakota 57104
?
mi
from
Sioux Falls, SD
Click here to add this to my saved trials
South Pasadena, California 91030
?
mi
from
South Pasadena, CA
Click here to add this to my saved trials
101 Nicolls Rd
Stony Brook, New York 11794
(631) 444-4000
Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
?
mi
from
Stony Brook, NY
Click here to add this to my saved trials
750 East Adams Street
Syracuse, New York 13210
?
mi
from
Syracuse, NY
Click here to add this to my saved trials
Tampa, Florida 33612
?
mi
from
Tampa, FL
Click here to add this to my saved trials
?
mi
from
Towson, MD
Click here to add this to my saved trials
Whippany, New Jersey 07981
?
mi
from
Whippany, NJ
Click here to add this to my saved trials