AzTrials
AzTrials

Prostatic Neoplasms, Castration-ResistantPhase 3IMbassador250NCT03016312

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

A Phase 3 study testing Atezolizumab and Enzalutamide in people with Prostatic Neoplasms, Castration-Resistant, run by Hoffmann-La Roche at 158 sites in 21 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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.… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Atezolizumab and Enzalutamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
759 participants
Where
158 sitesin 21 countries
Study dates
10 Jan 2017to 20 Dec 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

158 sites in 21 countries.

158 sites in 21 countries

United States39 sites

  • New York Oncology Hematology, P.C.

    Albany, New York, 12208

  • Virginia Cancer Specialists - Alexandria

    Alexandria, Virginia, 22304

  • University of Colorado; Division of Medical Oncology

    Aurora, Colorado, 80021

  • Texas Oncology Cancer Center

    Austin, Texas, 78731

  • MSKCC at Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Lynn Cancer Institute/Boca Raton Regional Hospital

    Boca Raton, Florida, 33486

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Charleston Oncology, P .A

    Charleston, South Carolina, 29414

  • Sarah Cannon Research Institute / Tennessee Oncology

    Chattanooga, Tennessee, 37404

  • Oncology Hematology Care, Inc.

    Cincinnati, Ohio, 45230

  • James Cancer Hospital;Solove Research Institute

    Columbus, Ohio, 43210

  • Texas Oncology - Methodist Dallas Cancer Center

    Dallas, Texas, 75203

  • Karmanos Cancer Institute..

    Detroit, Michigan, 48201

  • City of Hope Medical Grp Inc.

    Duarte, California, 91010

  • SCRI Florida Cancer Specialists South

    Fort Myers, Florida, 33916

  • Texas Oncology, P.A. - Fort Worth

    Fort Worth, Texas, 76104

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Texas Oncology - Memorial City

    Houston, Texas, 77024

  • Investigative Clin Rsch of IN

    Indianapolis, Indiana, 46260

  • Texas Oncology-Tyler

    Irving, Texas, 75063

  • University of California San Diego

    La Jolla, California, 92037-1337

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89128

  • Kaiser Permanente San Diego - Los Angeles

    Los Angeles, California, 90027

  • Miami Cancer Institute of Baptist Health, Inc.

    Miami, Florida, 33176

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • Yale School of Medicine

    New Haven, Connecticut, 06510-3206

  • Columbia University Medical Center

    New York, New York, 10032

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Nebraska Cancer Specialists; Oncology Hematology West, PC

    Omaha, Nebraska, 68130

  • Urology Cancer Center & GU Research Network

    Omaha, Nebraska, 68130

  • UC Irvine Medical Center

    Orange, California, 92868

  • Allegheny Cancer Center

    Pittsburgh, Pennsylvania, 15212

  • University of Pittsburgh Cancer Institute; Division of Medical Oncology

    Pittsburgh, Pennsylvania, 15232

  • Miriam Hospital

    Providence, Rhode Island, 02906

  • Associates in Oncology/Hematology P.C.

    Rockville, Maryland, 20850

  • Pacific Hematology Oncology Associates

    San Francisco, California, 94115

  • Florida Cancer Specialist, North Region

    St. Petersburg, Florida, 33705

  • Stamford Hospital; BCC, MOHR

    Stamford, Connecticut, 06904

Other trials in United States

Japan14 sites

  • Nagoya City University Hospital

    Aichi, 467-8602

  • National Cancer Center East

    Chiba, 277-8577

  • Toho University Sakura Medical Center

    Chiba, 285-8741

  • Kyushu University Hospital

    Fukuoka, 812-8582

  • National Hospital Organization Hokkaido Cancer Center

    Hokkaido, 003-0804

  • Yokohama City University Medical Center

    Kanagawa, 232-0024

  • Kitasato University Hospital

    Kanagawa, 252-0375

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

  • Nara Medical University Hospital

    Nara, 634-8522

  • Niigata University Medical & Dental Hospital

    Niigata, 951-8520

  • Kansai Medical University Hospital

    Osaka, 573-1191

  • Toranomon Hospital

    Tokyo, 105-8470

  • The Jikei University Hospital

    Tokyo, 105-8471

  • Nippon Medical School Hospital

    Tokyo, 113-8603

Other trials in Japan

Spain13 sites

  • Institut Catala d?Oncologia Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital Universitari Vall d'Hebron; Oncology

    Barcelona, 08035

  • Hospital Clínic i Provincial; Servicio de Oncología

    Barcelona, 08036

  • Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia

    Barcelona, 08041

  • Hospital Universitario Reina Sofia; Servicio de Oncologia

    Córdoba, Cordoba, 14004

  • Insititut Catala D'Oncologia

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital Ramon y Cajal; Servicio de Oncologia

    Madrid, 28034

  • Hospital Clinico San Carlos; Servicio de Oncologia

    Madrid, 28040

  • Hospital Universitario 12 de Octubre; Servicio de Oncologia

    Madrid, 28041

  • Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

    Málaga, 29010

  • Clinica Universitaria de Navarra; Servicio de Oncologia

    Pamplona, Navarre, 31008

  • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

    Sabadell, Barcelona, 8208

  • Hospital Universitario Virgen del Rocio; Servicio de Oncologia

    Seville, 41013

Other trials in Spain

Italy11 sites

  • Ospedale Area Aretina Nord; U.O.C. Oncologia

    Arezzo, Tuscany, 52100

  • Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica

    Bari, Apulia, 70124

  • A.O. Istituti Ospitalieri - Cremona; S.C. Oncologia

    Cremona, Lombardy, 26100

  • IRCCS AOU San Martino - IST; Oncologia Medica 1

    Genoa, Liguria, 16132

  • Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2

    Milan, Lombardy, 20133

  • Irccs Istituto Europeo Di Oncologia (IEO); Cure Mediche

    Milan, Lombardy, 20141

  • A.O. Universitaria Policlinico Di Modena; Oncologia

    Modena, Emilia-Romagna, 41124

  • ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico

    Naples, Campania, 80131

  • IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima

    Padova, Veneto, 35128

  • Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica

    Rome, Lazio, 00152

  • IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia

    San Giovanni Rotondo, Apulia, 71013

Other trials in Italy

France9 sites

  • Institut Sainte-Catherine; Oncologie

    Avignon, 84082

  • Centre Francois Baclesse; Oncologie

    Caen, 14076

  • Hopital Louis Pasteur; Medecine B

    Colmar, 68024

  • Centre Oscar Lambret; Chir Cancerologie General

    Lille, 59000

  • Clinique Chenieux; Oncology

    Limoges, 87039

  • Hopital Saint Louis, Service D Oncologie Medicale

    Paris, 75475

  • Hopital d'Instruction des Armees de Begin

    Saint-Mandé, 94160

  • Institut Claudius Regaud; Departement Oncologie Medicale

    Toulouse, 31059

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Canada8 sites

  • Tom Baker Cancer Centre-Calgary

    Calgary, Alberta, T2N 4N2

  • Hopital Charles Lemoyne; Centre Integre de Lutte Contre Le Cancer de La Monteregie

    Greenfield Park, Quebec, J4V 2H1

  • Kingston General Hospital

    Kingston, Ontario, K7L 2V7

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Lakeridge Health Oshawa; Oncology

    Oshawa, Ontario, L1G 2B9

  • CHU de Québec - Université Laval - Hôtel-Dieu de Québec

    Québec, G1J 1Z4

  • Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont

    Sherbrooke, Quebec, J1H 5N4

  • Princess Margaret Cancer Center

    Toronto, Ontario, M5G 1Z5

Other trials in Canada

Poland8 sites

  • Woj. Wielospec. Centrum Onkologii i Traumatologii

    ?ód?, 93-513

  • Medical University of Bialystok; Oncology clinic

    Bialystok, 15-027

  • Przychodnia Lekarska KOMED, Roman Karaszewski

    Konin, 62-500

  • Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii

    Krakow, 30-688

  • SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarawskiego

    Opole, 45-061

  • Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii

    Otwock, 05-400

  • Szpital Sw. Elzbiety - Mokotowskie Centrum Medyczne Sp. z o.o.

    Warsaw, 02-616

  • Wojewodzki Szpital; Specjalistyczny ul.

    Wroclaw, 51-124

Other trials in Poland

Greece7 sites

  • Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine

    Athens, 115 22

  • Alexandras Hospital; Dept. of Clin. Therapeutics, Athens Uni School of Medicine

    Athens, 115 28

  • Athens Medical Center; Dept. of Oncology

    Athens, 151 25

  • IASO General Hospital of Athens

    Athens, 155 62

  • Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.

    Kifissia, 145 64

  • University Hospital of Patras Medical Oncology

    Pátrai, 265 04

  • Papageorgiou General Hospital; Medical Oncology

    Thessaloniki, 564 29

Other trials in Greece

Australia6 sites

  • Eastern Health; Cancer Services

    Box Hill, New South Wales, 3128

  • Monash Medical Centre; Oncology

    Clayton, Victoria, 3168

  • Concord Repatriation General Hospital; Concord Cancer Centre

    Concord, New South Wales, 2139

  • Royal Brisbane & Women's Hosp; Cancer Care Serv

    Herston, Queensland, 4029

  • Adelaide Cancer Centre

    Kurralta Park, South Australia, 5037

  • Macquarie University Hospital

    Macquarie Park, New South Wales, 2113

Other trials in Australia

United Kingdom6 sites

  • Royal Blackburn Hospital

    Blackburn, BB2 3HH

  • Leicester Royal Infirmary

    Leicester, LE1 5WW

  • Barts and the London NHS Trust.

    London, EC1A 7BE

  • Sarah Cannon Research Institute

    London, W1G 6AD

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • Royal Marsden Hospital; Institute of Cancer Research

    Sutton, SM2 5PT

Other trials in United Kingdom

Germany5 sites

  • Universitätsklinikum Freiburg; Chirurgische Klinik; Abteilung Urologie

    Freiburg im Breisgau, 79106

  • Medizinische Hochschule Hannover; Klinik für Urologie und Onkologische Urologie

    Hanover, 30625

  • Universitätsklinikum Münster, Klinik für Urologie und Kinderurologie

    Münster, 48149

  • Universitätsklinikum Tübingen; Klinik für Urologie

    Tübingen, 72076

  • Urologisches Zentrum Euregio; Würselen, Urologische Praxis am Wasserturm

    Würselen, 52146

Other trials in Germany

China4 sites

  • Friendship Hospital, Capital Medical University

    Beijing, 100050

  • Jiangsu Cancer Hospital

    Nanjing, 211100

  • Zhongshan Hospital Fudan University

    Shanghai, 200032

  • Fudan University Shanghai Cancer Center

    Shanghai, 200120

Other trials in China

South Korea4 sites

  • National Cancer Center

    Goyang-si, 10408

  • Seoul National University Hospital

    Seoul, 03080

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Taiwan4 sites

  • Taichung Veterans General Hospital; Division of Urology

    Taichung, 407

  • National Taiwan University Hospital, Department of Urology

    Taipei, 10048

  • TAIPEI VETERANS GENERAL HOSPITAL, Urology

    Taipei, 11217

  • Chang Gung Memorial Hospital-LinKou; Urology

    Taoyuan, 333

Other trials in Taiwan

Austria3 sites

  • LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie

    Graz, 8036

  • Ordensklinikum Linz Elisabethinen; Abteilung für Urologie und Andrologie

    Linz, 4020

  • Medizinische Universität Wien; Universitätsklinik für Urologie

    Vienna, 1090

Other trials in Austria

Belgium3 sites

  • Onze Lieve Vrouwziekenhuis Aalst

    Aalst, 9300

  • UZ Gent

    Ghent, 9000

  • CHU Sart-Tilman

    Liège, 4000

Other trials in Belgium

Czechia3 sites

  • Masarykuv onkologicky ustav

    Brno, 656 53

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, 656 91

  • Thomayerova nemocnice

    Praha 4 - Krc, 140 59

Other trials in Czechia

Denmark3 sites

  • Aalborg Universitetshospital; Onkologisk Afdeling

    Aalborg, 9000

  • Herlev Hospital; Afdeling for Kræftbehandling

    Herlev, 2730

  • Odense Universitetshospital, Onkologisk Afdeling R

    Odense C, 5000

Other trials in Denmark

Hungary3 sites

  • Semmelwies University of Medicine; Urology Dept.

    Budapest, 1082

  • Orszagos Onkologiai Intezet; "C" Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály

    Budapest, 1122

  • Debreceni Egyetem Klinikai Kozpont ; Department of Oncology

    Debrecen, 4032

Other trials in Hungary

Russia3 sites

  • Russian Scientific Center of Roentgenoradiology

    Moscow, Moscow Oblast, 117997

  • P.A. Herzen Oncological Inst. ; Oncology

    Moscow, Moscow Oblast, 125248

  • SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF

    Saint Petersburg, Sankt-Peterburg, 197022

Other trials in Russia

Switzerland2 sites

  • Inselspital Bern; Universitätsklinik für Medizinische Onkologie, Klinische Forschungseinheit

    Bern, 3010

  • Kantonsspital St. Gallen; Onkologie/Hämatologie

    Sankt Gallen, 9007

Other trials in Switzerland

About this study

Official 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

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.

Medical subject headings
Prostatic Neoplasms, Castration-Resistant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtezolizumabDrug

    Also called Tecentriq®

    Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg), intravenous (IV) infusion on Day 1 of each 21-day cycle.

  • EnzalutamideDrug

    Also called Xtandi®

    Enzalutamide capsules will be administered orally at a dose of 160 mg daily.

Study groups in NCT03016312
Study groupRoleWhat they receive
Atezolizumab + EnzalutamideExperimentalParticipants will receive atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).
Receives: Drug: Atezolizumab; Drug: Enzalutamide
EnzalutamideActive comparatorParticipants will receive enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).
Receives: Drug: Enzalutamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    Overall Survival is defined as the time from randomization to death from any cause.

    Measured: Baseline until death from any cause (up to approximately 42 months)

Secondary outcomes (13)

  1. Percentage of Participants Who Survived at Month 6 and 12

    OS (Overall Survival is defined as the time from randomization to death from any cause) probability at 6 and 12 months

    Measured: Months 6, 12

  2. Time to First Symptomatic Skeletal Event (SSE)

    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.

    Measured: Baseline up to end of study (up to approximately 42 months)

  3. Radiographic Progression-Free Survival (rPFS), as Assessed by the Investigator and Adapted From the PCWG3 Criteria

    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

    Measured: Baseline until disease progression or death from any cause (up to approximately 42 months)

  4. Percentage of Participants Who Are Radiographic Progression-Free, as Assessed by the Investigator and Adapted From the PCWG3 Criteria

    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

    Measured: Months 6, 12

  5. Percentage of Participants With Greater Than (>) 50 Percent (%) Decrease in Prostate-Specific Antigen (PSA) From Baseline

    PSA response rate, defined as a > 50% decrease in PSA from baseline that is confirmed after ≥ 3 weeks by a consecutive confirmatory PSA measurement

    Measured: Baseline until disease progression (up to approximately 42 months)

  6. Time to PSA Progression, Assessed as Per PCWG3 Criteria

    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.

    Measured: Baseline until disease progression (up to approximately 42 months)

  7. Percentage of Participant With Objective Response, as Determined by the Investigator Through Use of PCWG3 Criteria

    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

    Measured: Baseline until disease progression or death from any cause (up to approximately 42 months)

  8. Percentage of Participants With Adverse Events

    Verbatim description of adverse events will be coded to MedDRA preferred terms and graded according to NCI CTCAE v4.0.

    Measured: Baseline up to end of study (up to approximately 42 month)

  9. Minimum Observed Serum Concentration (Cmin) of Atezolizumab

    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.

    Measured: 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)

  10. Maximum Observed Serum Concentration (Cmax) of Atezolizumab

    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.

    Measured: Day Cycle 1 Day 1 0.5 hr post-infusion (infusion duration: 60 minutes [min])

  11. Plasma Concentration of Enzalutamide

    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.

    Measured: 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

  12. Plasma Concentration of N-Desmethyl Enzalutamide

    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.

    Measured: 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

  13. Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab

    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.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2017 (estimated)
  2. Study start10 Jan 2017
  3. Primary completion24 Jun 2019
  4. Study completion20 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
759 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03016312
Sponsor's protocol ID
CO39385
Other IDs
2016-003092-22, 2016
Acronym
IMbassador250
Status last verified
Aug 2024
First submitted
9 Jan 2017
Last updated
9 Aug 2024
FDA-regulated drug
Yes
FDA-regulated device
No

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.

    PubMed 35013615

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atezolizumab and Enzalutamide in people with Prostatic Neoplasms, Castration-Resistant, run by Hoffmann-La Roche at 158 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 158 sites in United States, Japan, Spain, Italy, France and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Baseline until death from any cause (up to approximately 42 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03016312, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.

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