A Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Enzalutamide in Participants With Metastatic Castration-Resistant Prostrate Cancer (mCRPC) After Failure of an Androgen Synthesis Inhibitor And Failure of, Ineligibility For, or Refusal of a Taxane Regimen



Status:Active, not recruiting
Conditions:Prostate Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/26/2019
Start Date:January 10, 2017
End Date:July 9, 2022

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

A Phase III, Multicenter, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Enzalutamide Versus Enzalutamide Alone in Patients With Metastatic Castration-Resistant Prostate Cancer After Failure of an Androgen Synthesis Inhibitor and Failure of, Ineligibility for, or Refusal of a Taxane Regimen

This Phase III, multicenter, randomized, open-label study will evaluate the safety and
efficacy of atezolizumab (anti-programmed death-ligand 1 [anti-PD-L1] antibody) in
combination with enzalutamide compared with enzalutamide alone in participants with mCRPC
after failure of an androgen synthesis inhibitor (e.g., abiraterone) and failure of,
ineligibility for, or refusal of a taxane regimen. Participants will be randomized to one of
the two treatment arms (atezolizumab in combination with enzalutamide, and enzalutamide
alone) in a 1:1 ratio (experimental to control arm) in global randomized phase. Participants
will receive treatment until investigator-assessed confirmed radiographic disease progression
per Prostate Cancer Working Group 3 (PCWG3) criteria or unacceptable toxicity.


Inclusion Criteria:

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Life expectancy greater than or equal to (>/=) 3 months

- Histologically confirmed adenocarcinoma of the prostate

- Known castrate-resistant disease with serum testosterone level less than or equal to
( androgen deprivation for the duration of the study

- Progressive disease prior to screening by PSA or imaging per PCWG3 criteria during or
following the direct prior line of therapy in the setting of medical or surgical
castration

- One prior regimen/line of a taxane-containing regimen for mCRPC or refusal or
ineligibility of a taxane-containing regimen

- Progression on a prior regimen/line of an androgen synthesis inhibitor for prostate
cancer

- Availability of a representative tumor specimen from a site not previously irradiated
that is suitable for determination of programmed death-ligand 1 (PD-L1) status via
central testing

- Adequate hematologic and end organ function

Exclusion Criteria:

- Prior treatment with enzalutamide or any other newer hormonal androgen receptor
inhibitor (e.g., apalutamide, ODM-201)

- Treatment with any approved anti-cancer therapy, including chemotherapy,
immunotherapy, radiopharmaceutical or hormonal therapy (with the exception of
abiraterone), within 4 weeks prior to initiation of study treatment

- Treatment with abiraterone within 2 weeks prior to study treatment

- Structurally unstable bone lesions suggesting impending fracture

- Known or suspected brain metastasis or active leptomeningeal disease

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

- Active or history of autoimmune disease or immune deficiency

- Prior allogeneic stem cell or solid organ transplantation

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

- Positive human immunodeficiency virus (HIV) test, active tuberculosis, active
hepatitis B virus (HBV) or hepatitis C virus (HCV) infection

- Prior treatment with cluster of differentiation (CD)137 agonists or immune checkpoint
blockade therapies, including anti Cytotoxic T Lymphocyte-Associated 4 (CTLA4),
anti-programmed death 1 (PD-1), and anti-PD-L1 therapeutic antibodies

- Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of
the drug, whichever is shorter, prior to initiation of study treatment

- Treatment with systemic immunosuppressive medication within 2 weeks prior to
initiation of study

- History of seizure or any condition that may predispose to seizure within 12 months
prior to study treatment, including history of unexplained loss of consciousness or
transient ischemic attack
We found this trial at
56
sites
Orange, California 92868
?
mi
from
Orange, CA
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
Albany, New York 12206
?
mi
from
Albany, NY
Click here to add this to my saved trials
Alexandria, Virginia 22304
?
mi
from
Alexandria, VA
Click here to add this to my saved trials
Allentown, Pennsylvania 18105
?
mi
from
Allentown, PA
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
Basking Ridge, New Jersey 07920
?
mi
from
Basking Ridge, NJ
Click here to add this to my saved trials
Billings, Montana 59102
?
mi
from
Billings, MT
Click here to add this to my saved trials
?
mi
from
Boca Raton, FL
Click here to add this to my saved trials
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
?
mi
from
Boston, MA
Click here to add this to my saved trials
Box Hill, New South Wales
?
mi
from
Box Hill,
Click here to add this to my saved trials
Charleston, South Carolina 29403
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Chattanooga, Tennessee 37404
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
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
?
mi
from
Dallas, TX
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
Duarte, California 91010
?
mi
from
Duarte, CA
Click here to add this to my saved trials
?
mi
from
Eugene, OR
Click here to add this to my saved trials
Flemington, New Jersey 08822
?
mi
from
Flemington, NJ
Click here to add this to my saved trials
4371 Veronica S Shoemaker Boulevard
Fort Myers, Florida 33916
?
mi
from
Fort Myers, FL
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
500 Westchester Avenue
Harrison, New York 10604
?
mi
from
Harrison, NY
Click here to add this to my saved trials
80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
?
mi
from
Hartford, CT
Click here to add this to my saved trials
500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
?
mi
from
Hershey, PA
Click here to add this to my saved trials
Houston, Texas 77024
?
mi
from
Houston, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46260
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Irving, Texas 75063
?
mi
from
Irving, TX
Click here to add this to my saved trials
Kansas City, Missouri 64132
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
4867 Sunset Boulevard
Los Angeles, California 90027
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90033
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90033
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Marina Del Rey, California 90292
?
mi
from
Marina Del Rey, CA
Click here to add this to my saved trials
?
mi
from
Miami, FL
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
Nashville, Tennessee 37203
?
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
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
1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
?
mi
from
New York, NY
Click here to add this to my saved trials
5900 Lake Wright Dr
Norfolk, Virginia 23502
(757) 466-8683
Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
?
mi
from
Omaha, NE
Click here to add this to my saved trials
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15212
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
164 Summit Ave
Providence, Rhode Island 02906
(401) 793-2500
Miriam Hospital The Miriam Hospital is a private, not-for-profit hospital, with a history of providing...
?
mi
from
Providence, RI
Click here to add this to my saved trials
Rockville, Maryland 20850
?
mi
from
Rockville, MD
Click here to add this to my saved trials
1000 North Village Avenue
Rockville Centre, New York 11570
?
mi
from
Rockville Centre, NY
Click here to add this to my saved trials
1201 5th Avenue North
Saint Petersburg, Florida 33705
?
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
San Francisco, California 94115
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Stamford, Connecticut 06904
?
mi
from
Stamford, CT
Click here to add this to my saved trials
Tallahassee, Florida 32308
?
mi
from
Tallahassee, FL
Click here to add this to my saved trials