Clinical Trials List
Protocol NumberCO39385
NCT Number(ClinicalTrials.gov Identfier)NCT03016312
Completed
2017-02-01 - 2021-12-27
Phase III
Terminated3
Study ended1
ICD-10C61
Malignant neoplasm of prostate
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
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Trial Applicant
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Sponsor
Hoffmann-La Roche
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Trial scale
Multi-Regional Multi-Center
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Update
2026/08/24
Investigators and Locations
Co-Principal Investigator
- - - Division of Urology
- CHUNG-HSIN CHEN Division of Urology
- YU-CHUAN LU Division of Urology
- Yu-Chieh Tsai Division of Hematology & Oncology
- Ying-Chun Shen Division of Hematology & Oncology
- JHE-CYUAN GUO Division of Hematology & Oncology
- YEN-HENG LIN Division of Radiology
- CHING-CHU LU Division of Nuclear Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Co-Principal Investigator
- Yen-Hwa Chang Division of Urology
- Yi-Hsiu Huang Division of Urology
- Tzu-chun Wei Division of Urology
- 沈書慧 Division of Radiology
- 朱力行 Division of Nuclear Medicine
- 潘競成 Division of General Surgery
- Tzu-Ping Lin Division of Urology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Chuan-Shu Chen Division of Urology
- 裘坤元 Division of Urology
- Cheng-Kuang Yang Division of Urology
- 蔡世傳 Division of Nuclear Medicine
- 熊小澐 Division of Radiology
- Jian-Ri Li Division of Urology
- Cheng-Che Chen Division of Urology
The Actual Total Number of Participants Enrolled
0 Terminated
Principal Investigator
Yung-Chang Lin
Linkou Chang Gung Medical Foundation
Taiwan National PI
林永昌
Co-Principal Investigator
- Rita cheng Division of Hematology & Oncology
- See-Tong Pang Division of Hematology & Oncology
- 張英勛 Division of Hematology & Oncology
- 劉忠一 Division of Hematology & Oncology
- Po-Jung Su Division of Hematology & Oncology
- 黃成之 Division of Radiology
- Feng-Yuan Liu Division of Nuclear Medicine
The Actual Total Number of Participants Enrolled
7 Study ended
Audit
None
Condition/Disease
Prostatic Neoplasms, Castration-Resistant
Objectives
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.
Test Drug
Atezolizumab
Active Ingredient
Atezolizumab
Dosage Form
Injection
Dosage
1200 mg/20 ml
Endpoints
Primary Outcome Measures:
Overall Survival (OS)
Secondary Outcome Measures
Percentage of Participants Who Survived at Month 6 and 12
Time to First Symptomatic Skeletal Event (SSE)
Radiographic Progression-Free Survival (rPFS), as Assessed by the Investigator and Adapted From the PCWG3 Criteria
Percentage of Participants Who Are Radiographic Progression-Free, as Assessed by the Investigator and Adapted From the PCWG3 Criteria
Percentage of Participants With Greater Than (>) 50 Percent (%) Decrease in Prostate-Specific Antigen (PSA) From Baseline
Time to PSA Progression, Assessed as Per PCWG3 Criteria
Percentage of Participant With Objective Response, as Determined by the Investigator Through Use of PCWG3 Criteria
Percentage of Participants With Adverse Events
Minimum Observed Serum Concentration (Cmin) of Atezolizumab
Maximum Observed Serum Concentration (Cmax) of Atezolizumab
Plasma Concentration of Enzalutamide
Plasma Concentration of N-Desmethyl Enzalutamide
Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
Overall Survival (OS)
Secondary Outcome Measures
Percentage of Participants Who Survived at Month 6 and 12
Time to First Symptomatic Skeletal Event (SSE)
Radiographic Progression-Free Survival (rPFS), as Assessed by the Investigator and Adapted From the PCWG3 Criteria
Percentage of Participants Who Are Radiographic Progression-Free, as Assessed by the Investigator and Adapted From the PCWG3 Criteria
Percentage of Participants With Greater Than (>) 50 Percent (%) Decrease in Prostate-Specific Antigen (PSA) From Baseline
Time to PSA Progression, Assessed as Per PCWG3 Criteria
Percentage of Participant With Objective Response, as Determined by the Investigator Through Use of PCWG3 Criteria
Percentage of Participants With Adverse Events
Minimum Observed Serum Concentration (Cmin) of Atezolizumab
Maximum Observed Serum Concentration (Cmax) of Atezolizumab
Plasma Concentration of Enzalutamide
Plasma Concentration of N-Desmethyl Enzalutamide
Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
Inclution Criteria
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 ( 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
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 ( 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
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
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
The Estimated Number of Participants
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Taiwan
29 participants
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Global
730 participants
