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 |
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.
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
(=) 50 nanograms per deciliter (ng/dL) with prior surgical castration or ongoing
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
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
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500 University Dr
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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9280 W. Sunset Road
Suite 100
Las Vegas, Nevada 89148
Las Vegas, Nevada 89148
702.952.1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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823 82nd Parkway, Suite B
Myrtle Beach, South Carolina 29572
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...
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
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Pittsburgh, Pennsylvania 15232
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Miriam Hospital The Miriam Hospital is a private, not-for-profit hospital, with a history of providing...
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