Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03016312
Registration number
NCT03016312
Ethics application status
Date submitted
9/01/2017
Date registered
10/01/2017
Date last updated
9/08/2024
Titles & IDs
Public title
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
Query!
Scientific title
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
Query!
Secondary ID [1]
0
0
2016-003092-22
Query!
Secondary ID [2]
0
0
CO39385
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
IMbassador250
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Prostatic Neoplasms, Castration-Resistant
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Prostate
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Atezolizumab
Treatment: Drugs - Enzalutamide
Experimental: Atezolizumab + Enzalutamide - Participants will receive atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).
Active comparator: Enzalutamide - Participants will receive enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).
Treatment: Drugs: Atezolizumab
Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg), intravenous (IV) infusion on Day 1 of each 21-day cycle.
Treatment: Drugs: Enzalutamide
Enzalutamide capsules will be administered orally at a dose of 160 mg daily.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Overall Survival (OS)
Query!
Assessment method [1]
0
0
Overall Survival is defined as the time from randomization to death from any cause.
Query!
Timepoint [1]
0
0
Baseline until death from any cause (up to approximately 42 months)
Query!
Secondary outcome [1]
0
0
Percentage of Participants Who Survived at Month 6 and 12
Query!
Assessment method [1]
0
0
OS (Overall Survival is defined as the time from randomization to death from any cause) probability at 6 and 12 months
Query!
Timepoint [1]
0
0
Months 6, 12
Query!
Secondary outcome [2]
0
0
Time to First Symptomatic Skeletal Event (SSE)
Query!
Assessment method [2]
0
0
An SSE is defined as external beam radiation therapy to relieve skeletal symptoms (including initiation of radium-223 dichloride or other types of radionuclide therapy to treat symptoms of bone metastases), new symptomatic pathologic bone fracture, clinically apparent occurrence of spinal cord compression, or tumor related orthopedic surgical intervention.
Query!
Timepoint [2]
0
0
Baseline up to end of study (up to approximately 42 months)
Query!
Secondary outcome [3]
0
0
Radiographic Progression-Free Survival (rPFS), as Assessed by the Investigator and Adapted From the PCWG3 Criteria
Query!
Assessment method [3]
0
0
rPFS is defined as the time from randomization to the earliest occurrence of one of the following:
* A participant is considered to have progressed by bone scan if: The first bone scan with =2 new lesions compared to baseline is observed \< 12 weeks from randomization and is confirmed by a second bone scan taken =6 weeks later showing =2 additional new lesions (a total of =4 new lesions compared to baseline); the date of progression is the date of the first post-treatment scan, OR After the first post-treatment scan, =2 new lesions are observed relative to the first post-treatment scan, which is confirmed on a subsequent scan =6 weeks later; the date of progression is the date of the post-treatment scan when =2 new lesions were first documented.
* Progression of soft tissue lesions, as defined per PCWG3 modified RECIST v1.1
* Death from any cause
Query!
Timepoint [3]
0
0
Baseline until disease progression or death from any cause (up to approximately 42 months)
Query!
Secondary outcome [4]
0
0
Percentage of Participants Who Are Radiographic Progression-Free, as Assessed by the Investigator and Adapted From the PCWG3 Criteria
Query!
Assessment method [4]
0
0
rPFS is defined as the time from randomization to the earliest occurrence of one of the following:
* A participant is considered to have progressed by bone scan if: The first bone scan with =2 new lesions compared to baseline is observed \< 12 weeks from randomization and is confirmed by a second bone scan taken =6 weeks later showing =2 additional new lesions (a total of =4 new lesions compared to baseline); the date of progression is the date of the first post-treatment scan, OR After the first post-treatment scan, =2 new lesions are observed relative to the first post-treatment scan, which is confirmed on a subsequent scan =6 weeks later; the date of progression is the date of the post-treatment scan when =2 new lesions were first documented.
* Progression of soft tissue lesions, as defined per PCWG3 modified RECIST v1.1
* Death from any cause
Query!
Timepoint [4]
0
0
Months 6, 12
Query!
Secondary outcome [5]
0
0
Percentage of Participants With Greater Than (>) 50 Percent (%) Decrease in Prostate-Specific Antigen (PSA) From Baseline
Query!
Assessment method [5]
0
0
PSA response rate, defined as a \> 50% decrease in PSA from baseline that is confirmed after = 3 weeks by a consecutive confirmatory PSA measurement
Query!
Timepoint [5]
0
0
Baseline until disease progression (up to approximately 42 months)
Query!
Secondary outcome [6]
0
0
Time to PSA Progression, Assessed as Per PCWG3 Criteria
Query!
Assessment method [6]
0
0
In participants with no PSA decline from baseline, PSA progression is defined as a =25% increase and an absolute increase of =2 ng/mL above the baseline value, =12 weeks after baseline. In participants with an initial PSA decline from baseline, PSA progression is defined as a =25% increase and an absolute increase of =2 ng/mL above the nadir value, which is confirmed by a consecutive second value obtained =3 weeks later.
Query!
Timepoint [6]
0
0
Baseline until disease progression (up to approximately 42 months)
Query!
Secondary outcome [7]
0
0
Percentage of Participant With Objective Response, as Determined by the Investigator Through Use of PCWG3 Criteria
Query!
Assessment method [7]
0
0
Objective response rate in soft tissue lesions, defined as the percentage of participants with either a CR or PR on two consecutive occasions = 6 weeks apart, as determined by the investigator through use of PCWG3 criteria
Query!
Timepoint [7]
0
0
Baseline until disease progression or death from any cause (up to approximately 42 months)
Query!
Secondary outcome [8]
0
0
Percentage of Participants With Adverse Events
Query!
Assessment method [8]
0
0
Verbatim description of adverse events will be coded to MedDRA preferred terms and graded according to NCI CTCAE v4.0.
Query!
Timepoint [8]
0
0
Baseline up to end of study (up to approximately 42 month)
Query!
Secondary outcome [9]
0
0
Minimum Observed Serum Concentration (Cmin) of Atezolizumab
Query!
Assessment method [9]
0
0
Safety visit-Discontinued participants had these visits within approximately 120 days after the last dosing; Study Completion Pre-dose visit-Participants had these visits at the last treatment dosing, samples were taken before the last dosing; Early Discontinuation Pre-dose visit-Participants who discontinued the study had these visits within the 30 days after their last dosing but samples were takes before their last dosing; Study Completion visit-Participants had these visits at their last treatment dosing but samples were taken after their last dosing; Early Discontinuation visit-Participants who discontinued the study had the visits within the 30 days after their last dosing but samples were taken after their last dosing; Unscheduled and Unscheduled Pre-dose Visits- At these visits, participants' samples were collected without dosing event and before dosing dosing at a visit unscheduled per protocol respectively. Enzalutamide Arm had no Atezolizumab dosing.
Query!
Timepoint [9]
0
0
Pre-infusion (0 hour[hr]) on Day 1 Cycles 1, 2, 3, 4, 8, 12, 16 (Cycle length: 21 days); treatment discontinuation visit, 120 days after last dose (up to approximately 42 months)
Query!
Secondary outcome [10]
0
0
Maximum Observed Serum Concentration (Cmax) of Atezolizumab
Query!
Assessment method [10]
0
0
Safety visit-Discontinued participants had these visits within approximately 120 days after the last dosing; Study Completion Pre-dose visit-Participants had these visits at the last treatment dosing, samples were taken before the last dosing; Early Discontinuation Pre-dose visit-Participants who discontinued the study had these visits within the 30 days after their last dosing but samples were takes before their last dosing; Study Completion visit-Participants had these visits at their last treatment dosing but samples were taken after their last dosing; Early Discontinuation visit-Participants who discontinued the study had the visits within the 30 days after their last dosing but samples were taken after their last dosing; Unscheduled and Unscheduled Pre-dose Visits- At these visits, participants' samples were collected without dosing event and before dosing dosing at a visit unscheduled per protocol respectively. Enzalutamide Arm had no Atezolizumab dosing.
Query!
Timepoint [10]
0
0
Day Cycle 1 Day 1 0.5 hr post-infusion (infusion duration: 60 minutes [min])
Query!
Secondary outcome [11]
0
0
Plasma Concentration of Enzalutamide
Query!
Assessment method [11]
0
0
Safety visit-Discontinued participants had these visits within approximately 120 days after the last dosing; Study Completion Pre-dose visit-Participants had these visits at the last treatment dosing, samples were taken before the last dosing; Early Discontinuation Pre-dose visit-Participants who discontinued the study had these visits within the 30 days after their last dosing but samples were takes before their last dosing; Study Completion visit-Participants had these visits at their last treatment dosing but samples were taken after their last dosing; Early Discontinuation visit-Participants who discontinued the study had the visits within the 30 days after their last dosing but samples were taken after their last dosing; Unscheduled and Unscheduled Pre-dose Visits- At these visits, participants' samples were collected without dosing event and before dosing dosing at a visit unscheduled per protocol respectively. Enzalutamide Arm had no Atezolizumab dosing.
Query!
Timepoint [11]
0
0
Predose (0 hr) and 1 hr postdose on Day 1 Cycle 1 and 3 (Cycle length: 21 days); pre-dose (within 1 hr) on Day 1 Cycle 8
Query!
Secondary outcome [12]
0
0
Plasma Concentration of N-Desmethyl Enzalutamide
Query!
Assessment method [12]
0
0
Safety visit-Discontinued participants had these visits within approximately 120 days after the last dosing; Study Completion Pre-dose visit-Participants had these visits at the last treatment dosing, samples were taken before the last dosing; Early Discontinuation Pre-dose visit-Participants who discontinued the study had these visits within the 30 days after their last dosing but samples were takes before their last dosing; Study Completion visit-Participants had these visits at their last treatment dosing but samples were taken after their last dosing; Early Discontinuation visit-Participants who discontinued the study had the visits within the 30 days after their last dosing but samples were taken after their last dosing; Unscheduled and Unscheduled Pre-dose Visits- At these visits, participants' samples were collected without dosing event and before dosing dosing at a visit unscheduled per protocol respectively. Enzalutamide Arm had no Atezolizumab dosing.
Query!
Timepoint [12]
0
0
Predose (0 hr) and 1 hr postdose on Day 1 Cycle 1 and 3 (Cycle length: 21 days); pre-dose (within 1 hr) on Day 1 Cycle 8
Query!
Secondary outcome [13]
0
0
Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
Query!
Assessment method [13]
0
0
The numbers and proportions of ADA-positive participants and ADA-negative participants at baseline (baseline prevalence) and after baseline (post-baseline incidence) will be summarized by treatment group.
Enzalutamide Arm has no Atezolizumab dosing therefore no participants to include here for Atezolizumab ADA.
Query!
Timepoint [13]
0
0
Predose (0 hr) on Day 1 Cycles 1, 2, 3, 4, 8, 12, 16 (Cycle length: 21 days); at atezolizumab discontinuation visit (30 days after last dose); 120 days after last dose of atezolizumab; up to 42 months
Query!
Eligibility
Key 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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Males
Query!
Can healthy volunteers participate?
No
Query!
Key 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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
10/01/2017
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
20/12/2022
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
759
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Query!
Recruitment hospital [1]
0
0
Eastern Health; Cancer Services - Box Hill
Query!
Recruitment hospital [2]
0
0
Concord Repatriation General Hospital; Concord Cancer Centre - Concord
Query!
Recruitment hospital [3]
0
0
Macquarie University Hospital - Macquarie Park
Query!
Recruitment hospital [4]
0
0
Royal Brisbane & Women's Hosp; Cancer Care Serv - Herston
Query!
Recruitment hospital [5]
0
0
Adelaide Cancer Centre - Kurralta Park
Query!
Recruitment hospital [6]
0
0
Monash Medical Centre; Oncology - Clayton
Query!
Recruitment postcode(s) [1]
0
0
3128 - Box Hill
Query!
Recruitment postcode(s) [2]
0
0
2139 - Concord
Query!
Recruitment postcode(s) [3]
0
0
2113 - Macquarie Park
Query!
Recruitment postcode(s) [4]
0
0
4029 - Herston
Query!
Recruitment postcode(s) [5]
0
0
5037 - Kurralta Park
Query!
Recruitment postcode(s) [6]
0
0
3168 - Clayton
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Colorado
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Connecticut
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Indiana
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Maryland
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Massachusetts
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Michigan
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Nebraska
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Nevada
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
New Jersey
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
New York
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Ohio
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Pennsylvania
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Rhode Island
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
South Carolina
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Tennessee
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Texas
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Virginia
Query!
Country [20]
0
0
Austria
Query!
State/province [20]
0
0
Graz
Query!
Country [21]
0
0
Austria
Query!
State/province [21]
0
0
Linz
Query!
Country [22]
0
0
Austria
Query!
State/province [22]
0
0
Wien
Query!
Country [23]
0
0
Belgium
Query!
State/province [23]
0
0
Aalst
Query!
Country [24]
0
0
Belgium
Query!
State/province [24]
0
0
Gent
Query!
Country [25]
0
0
Belgium
Query!
State/province [25]
0
0
Liège
Query!
Country [26]
0
0
Canada
Query!
State/province [26]
0
0
Alberta
Query!
Country [27]
0
0
Canada
Query!
State/province [27]
0
0
Ontario
Query!
Country [28]
0
0
Canada
Query!
State/province [28]
0
0
Quebec
Query!
Country [29]
0
0
China
Query!
State/province [29]
0
0
Beijing
Query!
Country [30]
0
0
China
Query!
State/province [30]
0
0
Nanjing City
Query!
Country [31]
0
0
China
Query!
State/province [31]
0
0
Shanghai City
Query!
Country [32]
0
0
China
Query!
State/province [32]
0
0
Shanghai
Query!
Country [33]
0
0
Czechia
Query!
State/province [33]
0
0
Brno
Query!
Country [34]
0
0
Czechia
Query!
State/province [34]
0
0
Praha 4 - Krc
Query!
Country [35]
0
0
Denmark
Query!
State/province [35]
0
0
Aalborg
Query!
Country [36]
0
0
Denmark
Query!
State/province [36]
0
0
Herlev
Query!
Country [37]
0
0
Denmark
Query!
State/province [37]
0
0
Odense C
Query!
Country [38]
0
0
France
Query!
State/province [38]
0
0
Avignon
Query!
Country [39]
0
0
France
Query!
State/province [39]
0
0
Caen
Query!
Country [40]
0
0
France
Query!
State/province [40]
0
0
Colmar
Query!
Country [41]
0
0
France
Query!
State/province [41]
0
0
Lille
Query!
Country [42]
0
0
France
Query!
State/province [42]
0
0
Limoges
Query!
Country [43]
0
0
France
Query!
State/province [43]
0
0
Paris
Query!
Country [44]
0
0
France
Query!
State/province [44]
0
0
Saint-Mande
Query!
Country [45]
0
0
France
Query!
State/province [45]
0
0
Toulouse
Query!
Country [46]
0
0
France
Query!
State/province [46]
0
0
Villejuif
Query!
Country [47]
0
0
Germany
Query!
State/province [47]
0
0
Freiburg
Query!
Country [48]
0
0
Germany
Query!
State/province [48]
0
0
Hannover
Query!
Country [49]
0
0
Germany
Query!
State/province [49]
0
0
Münster
Query!
Country [50]
0
0
Germany
Query!
State/province [50]
0
0
Tübingen
Query!
Country [51]
0
0
Germany
Query!
State/province [51]
0
0
Würselen
Query!
Country [52]
0
0
Greece
Query!
State/province [52]
0
0
Athens
Query!
Country [53]
0
0
Greece
Query!
State/province [53]
0
0
Kifisia
Query!
Country [54]
0
0
Greece
Query!
State/province [54]
0
0
Patras
Query!
Country [55]
0
0
Greece
Query!
State/province [55]
0
0
Thessaloniki
Query!
Country [56]
0
0
Hungary
Query!
State/province [56]
0
0
Budapest
Query!
Country [57]
0
0
Hungary
Query!
State/province [57]
0
0
Debrecen
Query!
Country [58]
0
0
Italy
Query!
State/province [58]
0
0
Campania
Query!
Country [59]
0
0
Italy
Query!
State/province [59]
0
0
Emilia-Romagna
Query!
Country [60]
0
0
Italy
Query!
State/province [60]
0
0
Lazio
Query!
Country [61]
0
0
Italy
Query!
State/province [61]
0
0
Liguria
Query!
Country [62]
0
0
Italy
Query!
State/province [62]
0
0
Lombardia
Query!
Country [63]
0
0
Italy
Query!
State/province [63]
0
0
Puglia
Query!
Country [64]
0
0
Italy
Query!
State/province [64]
0
0
Toscana
Query!
Country [65]
0
0
Italy
Query!
State/province [65]
0
0
Veneto
Query!
Country [66]
0
0
Japan
Query!
State/province [66]
0
0
Aichi
Query!
Country [67]
0
0
Japan
Query!
State/province [67]
0
0
Chiba
Query!
Country [68]
0
0
Japan
Query!
State/province [68]
0
0
Fukuoka
Query!
Country [69]
0
0
Japan
Query!
State/province [69]
0
0
Hokkaido
Query!
Country [70]
0
0
Japan
Query!
State/province [70]
0
0
Kanagawa
Query!
Country [71]
0
0
Japan
Query!
State/province [71]
0
0
Kyoto
Query!
Country [72]
0
0
Japan
Query!
State/province [72]
0
0
Nara
Query!
Country [73]
0
0
Japan
Query!
State/province [73]
0
0
Niigata
Query!
Country [74]
0
0
Japan
Query!
State/province [74]
0
0
Osaka
Query!
Country [75]
0
0
Japan
Query!
State/province [75]
0
0
Tokyo
Query!
Country [76]
0
0
Korea, Republic of
Query!
State/province [76]
0
0
Goyang-si
Query!
Country [77]
0
0
Korea, Republic of
Query!
State/province [77]
0
0
Seoul
Query!
Country [78]
0
0
Poland
Query!
State/province [78]
0
0
?ód?
Query!
Country [79]
0
0
Poland
Query!
State/province [79]
0
0
Bialystok
Query!
Country [80]
0
0
Poland
Query!
State/province [80]
0
0
Konin
Query!
Country [81]
0
0
Poland
Query!
State/province [81]
0
0
Kraków
Query!
Country [82]
0
0
Poland
Query!
State/province [82]
0
0
Opole
Query!
Country [83]
0
0
Poland
Query!
State/province [83]
0
0
Otwock
Query!
Country [84]
0
0
Poland
Query!
State/province [84]
0
0
Warszawa
Query!
Country [85]
0
0
Poland
Query!
State/province [85]
0
0
Wroclaw
Query!
Country [86]
0
0
Russian Federation
Query!
State/province [86]
0
0
Moskovskaja Oblast
Query!
Country [87]
0
0
Russian Federation
Query!
State/province [87]
0
0
Sankt Petersburg
Query!
Country [88]
0
0
Spain
Query!
State/province [88]
0
0
Barcelona
Query!
Country [89]
0
0
Spain
Query!
State/province [89]
0
0
Cordoba
Query!
Country [90]
0
0
Spain
Query!
State/province [90]
0
0
Navarra
Query!
Country [91]
0
0
Spain
Query!
State/province [91]
0
0
Madrid
Query!
Country [92]
0
0
Spain
Query!
State/province [92]
0
0
Malaga
Query!
Country [93]
0
0
Spain
Query!
State/province [93]
0
0
Sevilla
Query!
Country [94]
0
0
Switzerland
Query!
State/province [94]
0
0
Bern
Query!
Country [95]
0
0
Switzerland
Query!
State/province [95]
0
0
St. Gallen
Query!
Country [96]
0
0
Taiwan
Query!
State/province [96]
0
0
Taichung
Query!
Country [97]
0
0
Taiwan
Query!
State/province [97]
0
0
Taipei
Query!
Country [98]
0
0
Taiwan
Query!
State/province [98]
0
0
Taoyuan
Query!
Country [99]
0
0
United Kingdom
Query!
State/province [99]
0
0
Blackburn
Query!
Country [100]
0
0
United Kingdom
Query!
State/province [100]
0
0
Leicester
Query!
Country [101]
0
0
United Kingdom
Query!
State/province [101]
0
0
London
Query!
Country [102]
0
0
United Kingdom
Query!
State/province [102]
0
0
Manchester
Query!
Country [103]
0
0
United Kingdom
Query!
State/province [103]
0
0
Sutton
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Hoffmann-La Roche
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT03016312
Query!
Trial related presentations / publications
Powles T, Yuen KC, Gillessen S, Kadel EE 3rd, Rathkopf D, Matsubara N, Drake CG, Fizazi K, Piulats JM, Wysocki PJ, Buchschacher GL Jr, Alekseev B, Mellado B, Karaszewska B, Doss JF, Rasuo G, Datye A, Mariathasan S, Williams P, Sweeney CJ. Atezolizumab with enzalutamide versus enzalutamide alone in metastatic castration-resistant prostate cancer: a randomized phase 3 trial. Nat Med. 2022 Jan;28(1):144-153. doi: 10.1038/s41591-021-01600-6. Epub 2022 Jan 10.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Clinical Trials
Query!
Address
0
0
Hoffmann-La Roche
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/12/NCT03016312/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/12/NCT03016312/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03016312
Download to PDF