Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
1,164
Countries
11
Sites
77
Metastatic Castration-Resistant Prostate Cancer
1. To compare pembrolizumab plus enzalutamide versus placebo plus enzalutamide with respect to overall survival (OS) 2. To compare pembrolizumab plus enzalutamide versus placebo plus enzalutamide with respect to radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Eva…
Key facts
- Sponsor
- Merck Sharp & Dohme LLC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 23 Aug 2019 → 20 Aug 2025
- Decision date (initial)
- 2023-01-30
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Merck Sharp & Dohme LLC
External identifiers
- EU CT number
- 2022-500785-10-00
- EudraCT number
- 2018-004117-40
- WHO UTN
- U1111-1278-1151
- ClinicalTrials.gov
- NCT03834493
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Therapy, Pharmacogenomic, Pharmacogenetic, Efficacy, Diagnosis
1. To compare pembrolizumab plus enzalutamide versus placebo plus enzalutamide with respect to overall survival (OS)
2. To compare pembrolizumab plus enzalutamide versus placebo plus enzalutamide with respect to radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR)
Secondary objectives 4
- To compare pembrolizumab plus enzalutamide versus placebo plus enzalutamide with respect to the time to initiation of the first subsequent anti-cancer therapy or death (TFST)
- To compare pembrolizumab plus enzalutamide versus placebo plus enzalutamide with respect to the: prostate-specific antigen (PSA) response rate; PSA undetectable rate; and the objective response rate (ORR) and duration of response (DOR) per PCWG-modified RECIST 1.1 as assessed by BICR
- To compare pembrolizumab plus enzalutamide versus placebo plus enzalutamide with respect to the: time to PSA progression; time to first symptomatic skeletal-related event (SSRE); time to radiographic soft tissue progression per soft tissue rules of PCWG-modified RECIST 1.1, as assessed by BICR; and time to pain progression (TTPP) based on Brief Pain Inventory-Short Form (BPI-SF) Item 3 “ worst pain in 24 hours” and opiate analgesic use Analgesic Quantification Algorithm (AQA) score
- To evaluate the safety and tolerability of pembrolizumab plus enzalutamide versus placebo plus enzalutamide
Conditions and MedDRA coding
Metastatic Castration-Resistant Prostate Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10036909 | Prostate cancer metastatic | 100000004864 |
| 21.1 | LLT | 10076506 | Castration-resistant prostate cancer | 10029104 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Overall Study A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-641)
|
Randomised Controlled | Double | [{"id":145159,"code":1,"name":"Subject"},{"id":145157,"code":3,"name":"Monitor"},{"id":145158,"code":2,"name":"Investigator"}] | Arm 1: Pembro + Enzalutamide Arm 2: Placebo + Enzalutamide |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
- Prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months prior to randomization
- Current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography/magnetic resonance imaging (CT/MRI)
- Ongoing androgen deprivation with serum testosterone <50 ng/dL (<2.0 nM)
Exclusion criteria 7
- Known additional malignancy that is progressing or has required active treatment in the last 3 years
- Active autoimmune disease that has required systemic treatment in past 2 years
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
- Gastrointestinal disorder affecting absorption or is unable to swallow tablets/capsules
- Known active human immunodeficiency virus (HIV), concurrent active hepatitis B virus (HBV) or known active hepatitis C virus (HCV) infection
- History of seizure or any condition that may predispose to seizure
- Received prior treatment with radium or other therapeutic radiopharmaceuticals for prostate cancer
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Overall Survival (OS)
- Radiographic Progression-free Survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR)
Secondary endpoints 11
- Time to Initiation of the First Subsequent Anti-Cancer Therapy or Death (TFST)
- Prostate-specific Antigen (PSA) Response Rate
- Prostate-specific Antigen (PSA) Undetectable Rate
- Objective Response Rate (ORR) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR)
- Duration of Response (DOR) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR)
- Time to Prostate-specific Antigen (PSA) Progression
- Time to Radiographic Soft Tissue Progression per Soft Tissue Rules of Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR)
- Time to Pain Progression (TTPP)
- Time to First Symptomatic Skeletal-Related Event (SSRE)
- Number of Participants Who Experienced At Least One Adverse Event (AE)
- Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SUB77412 · Substance
- Active substance
- Enzalutamide
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 160 mg milligram(s)
- Max total dose
- 116.8 g gram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
KEYTRUDA 25 mg/mL concentrate for solution for infusion
PRD4323105 · Product
- Active substance
- Pembrolizumab
- Substance synonyms
- Lambrolizumab, MK-3475, SCH-900475, ABP 234
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 10.4 g gram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF02 — -
- Marketing authorisation
- EU/1/15/1024/002
- MA holder
- MERCK SHARP & DOHME BV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Merck Sharp & Dohme LLC
- Sponsor organisation
- Merck Sharp & Dohme LLC
- Address
- 1 Merck Drive, P. O. Box 100 P. O. Box 100
- City
- Whitehouse Station
- Postcode
- 08889-3400
- Country
- United States
Scientific contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Jelena Todoric
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Jelena Todoric
Third parties 7
| Organisation | City, country | Duties |
|---|---|---|
| Pharmaceutical Product Development LLC ORG-100016999
|
Richmond, United States | Laboratory analysis |
| Bioclinica Inc. ORG-100033079
|
Princeton, United States | Other |
| Neogenomics Laboratories Inc. ORG-100041804
|
San Diego, United States | Laboratory analysis |
| Parexel International Corporation ORG-100007310
|
Auburndale, United States | Other |
| Labcorp Drug Development Inc. ORG-100041590
|
Princeton, United States | Laboratory analysis |
| Perceptive Eclinical Limited ORG-100041144
|
Nottingham, United Kingdom | Other |
| Signant Health Inc. ORG-100040732
|
Blue Bell, United States | E-data capture |
Locations
11 EU/EEA countries · 77 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 27 | 2 |
| Bulgaria | Ended | 1 | 1 |
| Czechia | Ended | 6 | 2 |
| France | Ended | 70 | 18 |
| Germany | Ended | 53 | 11 |
| Hungary | Ended | 12 | 4 |
| Ireland | Ended | 16 | 3 |
| Italy | Ended | 40 | 9 |
| Netherlands | Ended | 58 | 10 |
| Poland | Ended | 50 | 4 |
| Spain | Ended | 87 | 13 |
| Rest of world
Turkey, United Kingdom, Argentina, Canada, Israel, Colombia, Brazil, Japan, Australia, Puerto Rico, United States, Chile, Russian Federation, Korea, Republic of, Ukraine
|
— | 744 | — |
Investigational sites
Ordensklinikum Linz GmbH
Department of Urology and Andrology, Fadingerstrasse 1, 4020, Linz
Medical University Of Vienna
Department of Urology and Andrology, Waehringer Guertel 18-20, Alsergrund, Vienna
Complex Oncological Center Plovdiv EOOD
Department of medical oncology and oncological diseases in gastroenterology, Bulevard Aleksandir Stamboliyski 2a, 4004, Plovdiv
Fakultni Nemocnice U Sv Anny V Brne
Onkologicko-chirurgické oddělení, Pekarska 53, Stare Brno, Brno
Nemocnice AGEL Novy Jicin a.s.
Oddělení radioterapie, Purkynova 2138/16, 741 01, Novy Jicin
Institut Mutualiste Montsouris
Oncology, 42 Boulevard Jourdan, 75014, Paris
Centre Hospitalier Regional D'orleans
Oncology, 14 Avenue De L Hopital, Cs 86709, Orleans Cedex 2
Institut Gustave Roussy
Oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut Sainte Catherine
Oncology, 250 Chemin De Baigne Pieds, 84000, Avignon
Centre Hospitalier De Saint-Quentin
Oncology, 1 Avenue Michel De L'hospital, 02100, Saint-Quentin
Hospices Civils De Lyon
Oncology, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Hospital Foch
Oncology, 40 Rue Worth, 92150, Suresnes
Centre Hospitalier Universitaire Amiens Picardie
Oncology, 1 Rond Point Du Professeur Christian Cabrol, 80054, Amiens
Institut Regional Du Cancer De Montpellier
Oncology, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5
Centre Hospitalier De Valenciennes
Oncology, 114 Avenue Desandrouin, 59300, Valenciennes
Institut Claudius Regaud
Oncology, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Centre Hospitalier Universitaire De Nantes
Oncology, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Centre Hospitalier Regional Et Universitaire De Brest
Oncology, 2 Avenue Marechal Foch, 29200, Brest
Institut Bergonie
Oncology, 229 Cours De L Argonne, 33000, Bordeaux
Groupe Hospitalier Saint Vincent
Oncology, 182 Route De La Wantzenau, 67000, Strasbourg
Centre Jean Perrin
Oncology, 58 Rue Montalembert, 63000, Clermont-Ferrand
Besancon University Hospital Center
Oncology, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
Medipole De Nancy
Oncology, 2 Rue Marie Marvingt, 54100, Nancy
Medical Center - University Of Freiburg
Klinik für Urologie, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
University Hospital Jena KöR
Klinik und Poliklinik für Urologie, Am Klinikum 1, Lobeda, Jena
Charite Universitatsmedizin Berlin KöR
Klinik für Urologie, Charitéplatz 1, Mitte, Berlin
Universitaetsklinikum Tuebingen
Universitätsklinik für Urologie, Hoppe-Seyler-Strasse 3, Nordstadt, Tuebingen
Studienpraxis Urologie
NA, Steinengrabenstrasse 17, 72622, Nuertingen
Klinikum rechts der Isar der TU Muenchen AöR
Urologische Klinik und Poliklinik, Ismaninger Straße 22, Au-Haidhausen, Munich
Universitatsklinikum Munster AöR
Klinik für Urologie und Kinderurologie, Gebaeude A1, Albert-Schweitzer-Campus 1, Muenster
Klinikum Nuernberg
NA, Prof.-Ernst-Nathan-Strasse 1, St. Johannis, Nuremberg
University Medical Centre Schleswig-Holstein
Klinik für Urologie Campus Lübeck, Ratzeburger Allee 160, 23538, Lübeck
Universitaetsmedizin Goettingen
Urologische Klinik und Poliklinik, Robert-Koch-Strasse 40, Weende, Goettingen
Barmherzige Brueder Trier gGmbH
Abteilung für Urologie und Kinderurologie Institut für Lithotripsie, Nord, Nordallee 1, Trier
Central Hospital Of Northern Pest Military Hospital
Onkológiai Osztály, Podmaniczky Utca 109, 1062, Budapest VI
Bacs-Kiskun Varmegyei Oktatokorhaz
Onkoradiológiai Központ, Nyiri Ut 38, 6000, Kecskemet
Orszagos Onkologiai Intezet
Gyógyszerterápiás Központ; Urogenitális Tumorok és Klinikai Farmakológiai Osztály "KEMOTERÁPIA C", Rath Gyorgy Utca 7-9, Kerulet, Budapest XII
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Onkoradiológiai Osztály, Vasvari Pal Utca 2-4, 9024, Gyor
Adelaide And Meath Hospital
Oncology/Haematology Clinical Trials, Oncology Day Unit, Tallaght By-Pass, Tallaght, Dublin 24
Beaumont Hospital
Cancer Clinical Trials and Research Unit, Beaumont Road, Beaumont, Dublin 9
University Hospital Limerick
Mid Western Cancer Centre, Saint Nessan's Road, V94 F858, Dooradoyle
Azienda Ospedaliero Universitaria Di Modena
Centro Oncologico Modenese, Largo Del Pozzo 71, 41124, Modena
IRCCS Istituto Nazionale Tumori Fondazione Pascale
SC Oncologia Clinica Sperimentale Uro-Ginecologica, Via Mariano Semmola 52, 80131, Naples
Azienda Ospedaliera Per Lemergenza Cannizzaro
U.O.C. Oncologia Medica, Via Messina 829, 95126, Catania
Presidio Ospedaliero Santa Maria delle Grazie
U.O.C. Oncologia, Via domitiana, 80078, Località la Schiana, Pozzuoli (NA)
Centro Di Riferimento Oncologico Di Aviano
S.O.C. Oncologia Medica e dei Tumori Immunocorrelati, Via Franco Gallini 2, 33081, Aviano
Humanitas Research Hospital
U.O. Oncologia Medica ed Ematologia, Via Alessandro Manzoni 56, 20089, Rozzano
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
U.O.C. Oncologia Medica, Largo Francesco Vito 1, 00168, Rome
IRCCS Azienda Ospedaliero-Universitaria Di Bologna
Unità Operativa di Oncologia Medica, Via Pietro Albertoni 15, 40138, Bologna
Azienda Ospedaliera S Maria Di Terni
Oncologia Medica, Viale Tristano Di Joannuccio 1, 05100, Terni
Medical Center Haaglanden
Oncology, Lijnbaan 32, 2512 VA, 's-Gravenhage
Amsterdam UMC
Oncology, De Boelelaan 1117, 1081 HV, Amsterdam
University Hospital Maastricht
Oncology, P. O. Box 5800, 6202 AZ, Maastricht
Stichting Noordwest Ziekenhuisgroep
Oncology, Wilhelminalaan 12, 1815 JD, Alkmaar
Stichting Radboud University Medical Center
Oncology, Geert Grooteplein Noord 9, 6525 EZ, Nijmegen
Stichting Ziekenhuisgroep Twente
Oncology, Zilvermeeuw 1, 7609 PP, Almelo
Tergooiziekenhuizen
Oncology, Van Riebeeckweg 212, 1213 XZ, Hilversum
Stichting Sint Franciscus Vlietland Groep
Oncology, Kleiweg 500, 3045 PM, Rotterdam
Stichting Catharina Ziekenhuis
Oncology, Michelangelolaan 2, 5623 EJ, Eindhoven
Amphia Hospital
Oncology, Langendijk 75, 4819 EV, Breda
I Przychodnia Lekarska Komed Roman Karaszewski II Osrodek Badan Klinicznych III Restauracja Rogatka Roman Karaszewski
Przychodnia Lekarska KOMED, Ul. Wojska Polskiego 6, 62-500, Konin
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Ambulatorium Chemioterapii, Ul. Izabeli Romanowskiej 2, 85-796, Bydgoszcz
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Oddział Dzienny Chemioterapii, Ul. Tytusa Chalubinskiego 7, 75-581, Koszalin
Provita Centrum Medyczne Sp. z o.o.
Provita Centrum Medyczne Sp. z o.o., Ul. Jana Pawla II 35, 97-200, Tomaszow Mazowiecki
Hospital Universitario Virgen De La Victoria
Montesa Genitourinary Oncology, Calle Del Arroyo Teatinos S N, 29010, Malaga
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario Quironsalud Madrid
Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital General Universitario Gregorio Maranon
Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitari De Girona Doctor Josep Trueta
Oncology, Avinguda De Franca S/n, 17007, Girona
Hospital San Pedro de Alcantara
Oncology, Avenida De Pablo Naranjo Porras S/n, 10002, Caceres
Clara Campal Comprehesive Cancer Center
Oncology, Calle Ona 10, 28050, Madrid
Hospital Clinico San Carlos
Oncology, Calle Del Profesor Martin Lagos S/n, 28040, Madrid
Parc Tauli Hospital Universitari
Oncology, Parc Del Tauli 1 Edifici Santa Fe Ala Izquierda Planta 2ª, 08208, Sabadell
MD Anderson Cancer Center
Oncology, Calle De Arturo Soria Nº 270, 28033, Madrid
Catalan Institute Of Oncology
Oncology, Avinguda Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Fundacion Instituto Valenciano De Oncologia
Oncology, Calle Professor Beltran Baguena 8, 46009, Valencia
Hospital Del Mar
Oncology, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2019-09-09 | 2023-10-06 | 2019-09-22 | 2022-04-29 | |
| Bulgaria | 2021-04-06 | 2023-02-20 | 2021-05-17 | 2022-04-29 | |
| Czechia | 2021-08-16 | 2023-09-20 | 2021-08-19 | 2022-04-29 | |
| France | 2019-10-11 | 2023-10-25 | 2019-10-22 | 2022-04-29 | |
| Germany | 2020-03-06 | 2023-10-17 | 2020-03-09 | 2022-04-29 | |
| Hungary | 2020-07-24 | 2024-07-12 | 2020-08-30 | 2022-04-29 | |
| Ireland | 2020-01-10 | 2023-10-31 | 2020-01-31 | 2022-04-29 | |
| Italy | 2019-08-23 | 2023-09-28 | 2019-08-30 | 2022-04-29 | |
| Netherlands | 2019-09-09 | 2023-11-14 | 2019-10-07 | 2022-04-29 | |
| Poland | 2019-09-09 | 2023-11-24 | 2019-09-10 | 2022-04-29 | |
| Spain | 2019-09-09 | 2025-08-20 | 2019-09-12 | 2022-04-29 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 37 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2022-500785-10-00_for pub | 09R |
| Protocol (for publication) | D4_Analgesic log_for publication | 12Mar19 |
| Protocol (for publication) | D4_Subject questionnaire_Analgesic Log_DEU_DE_for pub | 2.0 |
| Protocol (for publication) | D4_Subject questionnaire_english_for publication | 22jan2019 |
| Protocol (for publication) | D4_Subject questionnaire_subject facing screen report BPI-SF_DEU_DE_for pub | 1 |
| Protocol (for publication) | D4_Subject questionnaire_subject facing screen report_DEU_DE_for pub | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_ESP_Spanish_for publication | 25JAN2019 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_HUN_EN_for pub | 05MAY2023 |
| Recruitment arrangements (for publication) | K2_Recruitment Material Patient Brochure_HUN_Hungarian_for publication | 18Jan2019 |
| Subject information and informed consent form (for publication) | L1_ICF_Genetic consent_HUN_HU_for pub | v0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_HUN_HU_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_ESP_ES_SM12_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_HUN_HU_for pub | v0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_ESP_ES_for pub | 3.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_HUN_HU_for pub | 3.01R |
| Subject information and informed consent form (for publication) | L1_ICF_Main_ESP_All_spanish_TC_for publication | 05JUL2022 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional addendum_ESP_Spanish_for publication_ | 12FEB2019 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC quality and RSI_Enzalutamide Xtandi_for publication | 30OCT2018 |
| Synopsis of the protocol (for publication) | D1_PPLS_2022-500785-10-00_for pub | 26MAY2023 |
| Synopsis of the protocol (for publication) | D1_PPLS_AUT_DE_2022-500785-10_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_CZE_CS_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_DEU_DE_ 2022-500785-10-00_for pub | 1.0R |
| Synopsis of the protocol (for publication) | D1_PPLS_ESP_ES_2022-500785-10-00_for pub | 01 |
| Synopsis of the protocol (for publication) | D1_PPLS_FRA_FR_2022-500785-10_for pub | 1.0R |
| Synopsis of the protocol (for publication) | D1_PPLS_HUN_HU_2022-500785-10_for pub | v1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_ITA_IT_202250078510_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_NLD_NL_2022-500785-10_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_POL_PL_2022-500785-10_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Plain Language Summary_AUT_German_for publication | v00 |
| Synopsis of the protocol (for publication) | D1_Protocol plain language summary_Bulgaria_Bulgarian_for publication | 02JUN2022 |
| Synopsis of the protocol (for publication) | D1_Protocol Plain Language Summary_ESP_Spanish_for publication | 02JUN2022 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_CZE_Czech_for publication | 22FEB2021 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_DEU_German_for publication | v00 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_FRA_French_for publication | 08JUL2022 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_HUN_Hungarian_for publication | 29MAR2021 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_ITA_Italian_for publication | 6.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_POL_2022-500785-10-00_Polish_for publication | 18JAN2019 |
Application history
12 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-12-15 | Netherlands | Acceptable 2023-01-24
|
2023-01-24 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-06-23 | Netherlands | Acceptable 2023-08-22
|
2023-08-22 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-09-27 | Acceptable | 2023-10-28 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-5 | 2023-09-29 | Acceptable | 2023-11-10 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2023-10-04 | Acceptable | 2023-10-26 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-01-12 | Netherlands | Acceptable 2024-03-11
|
2024-03-11 |
| 7 | SUBSTANTIAL MODIFICATION | SM-8 | 2024-08-07 | Netherlands | Acceptable 2024-09-23
|
2024-09-23 |
| 8 | SUBSTANTIAL MODIFICATION | SM-10 | 2024-12-03 | Acceptable 2025-02-17
|
2025-02-18 | |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-03-20 | Netherlands | Acceptable 2025-02-17
|
2025-03-20 |
| 10 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-04-16 | Acceptable | 2025-05-17 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-12 | 2025-07-04 | Acceptable 2025-08-19
|
2025-08-21 | |
| 12 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-09-10 | Netherlands | Acceptable 2025-08-19
|
2025-09-10 |