Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruiting
Participants planned
361
Countries
7
Sites
30
Metastatic castrate resistant prostate cancer - mCRPC
1. Efficacy Phase: To evaluate the safety and tolerability for each treatment arm. 2. Efficacy Phase: To estimate the PSA response rate for each treatment arm. 3. Safety Lead-in (combination arms only): To evaluate the safety and tolerability and to establish an RP2D of treatment combinations that have not been evaluat…
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
- 12 Aug 2025 → ongoing
- Decision date (initial)
- 2025-07-08
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Daiichi Sankyo · Merck Sharp & Dohme LLC
External identifiers
- EU CT number
- 2024-516036-94-00
- WHO UTN
- U1111-1310-5406
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacogenomic, Pharmacodynamic, Pharmacokinetic, Safety, Efficacy, Therapy, Pharmacogenetic
1. Efficacy Phase: To evaluate the safety and tolerability for each treatment arm.
2. Efficacy Phase: To estimate the PSA response rate for each treatment arm.
3. Safety Lead-in (combination arms only): To evaluate the safety and tolerability and to establish an RP2D of treatment combinations that have not been evaluated in a separate study.
Secondary objectives 7
- Efficacy Phase: To estimate the ORR per PCWG-Modified RECIST 1.1, as assessed by BICR, for each treatment arm.
- Efficacy Phase: To evaluate rPFS per PCWG-Modified RECIST 1.1, as assessed by BICR, for each treatment arm.
- Efficacy Phase: To evaluate OS for each treatment arm.
- Efficacy Phase: To evaluate the DOR per PCWG-Modified RECIST 1.1, as assessed by BICR for each treatment arm.
- Efficacy Phase: To evaluate the TFST for each treatment arm.
- Efficacy Phase: To evaluate the time to PSA progression for each treatment arm.
- Efficacy Phase: To evaluate the TTPP for each treatment arm.
Conditions and MedDRA coding
Metastatic castrate resistant prostate cancer - mCRPC
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | PT | 10036909 | Prostate cancer metastatic | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
- Has prostate cancer progression while on androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months before Screening
- Has current evidence of metastatic disease
- Has received prior treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and progressed during or after treatment
- Participants receiving bone resorptive therapy (including, but not limited to bisphosphonate or denosumab) must have been on stable doses for ≥4 weeks before allocation/randomization
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 10 days before allocation/randomization
- Has prior treatment with poly-ADP-ribose polymerase inhibitors (PARPi) if indicated by local approved regimen or were deemed ineligible to receive PARPi by the investigator
Exclusion criteria 13
- Has any history of ILD/pneumonitis irrespective of prior steroid use, current ILD, ILD that cannot be ruled out at screening, or suspected ILD
- Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
- Uncontrolled or significant cardiovascular disease
- History of pituitary dysfunction
- Poorly controlled diabetes mellitus
- History or current condition of adrenal insufficiency (eg, Addison’s disease)
- Has received prior treatment with taxane-based chemotherapy agent for mCRPC.
- Chronic steroid treatment (dose of >10 mg daily prednisone equivalent), except for low-dose inhaled steroids (for asthma/chronic obstructive pulmonary disease), topical steroids (for mild skin conditions), or intra-articular steroid injections
- Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
- Known additional malignancy that is progressing or has required active treatment within the past 3 years
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Active autoimmune disease that has required systemic treatment in the past 2 years
- History of allogeneic tissue/solid organ transplant
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 7
- 1. Efficacy Phase: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) - Combination Arms Only
- 2. Efficacy Phase: Number of Participants Who Experienced an Adverse Event (AE)
- 3. Efficacy Phase: Number of Participants Who Discontinued Study Intervention Due to an AE
- 4. Efficacy Phase: Prostate-Specific Antigen (PSA) response rate
- 5. Safety Lead-in Phase: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) - Combination Arms Only
- 6. Safety Lead-in Phase: Number of Participants Who Experienced an Adverse Event (AE) - Combination Arms Only
- 7. Safety Lead-in Phase: Number of Participants Who Discontinued Study Intervention Due to an AE - Combination Arms Only
Secondary endpoints 7
- Efficacy Phase: Objective Response Rate (ORR)
- Efficacy Phase: Radiographic Progression-Free Survival (rPFS)
- Efficacy Phase: Overall Survival (OS)
- Efficacy Phase: Duration of Response (DOR)
- Efficacy Phase: Time to First Subsequent Anticancer Therapy (TFST)
- Efficacy Phase: Time to Prostate-Specific Antigen (PSA) Progression
- Efficacy Phase: Time to Pain Progression (TTPP)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 6
SCP104122323 · ATC
- Active substance
- Enzalutamide
- Substance synonyms
- MDV3100
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- L02BB04 — ENZALUTAMIDE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP107974752 · ATC
- Active substance
- Prednisolone
- Substance synonyms
- (8S,9S,10S,11S,13S,14S,17R)-11,17-DIHYDROXY-17-(2-HYDROXYACETYL)-10,13-DIMETHYL-7,8,9,11,12,14,15,16-OCTAHYDRO-6H-CYCLOPENTA[A]PHENANTHREN-3-ONE, GLPG0303, DELTA-HYDROCORTISONE, 1,2-DEHYDROHYDROCORTISONE, METACORTANDRALONE
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- H02AB06 — PREDNISOLONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP132446 · ATC
- Active substance
- Abiraterone
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- L02BX03 — ABIRATERONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD11627628 · Product
- Active substance
- Ifinatamab Deruxtecan
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
SCP107216203 · ATC
- Active substance
- Prednisolone
- Substance synonyms
- (8S,9S,10S,11S,13S,14S,17R)-11,17-DIHYDROXY-17-(2-HYDROXYACETYL)-10,13-DIMETHYL-7,8,9,11,12,14,15,16-OCTAHYDRO-6H-CYCLOPENTA[A]PHENANTHREN-3-ONE, GLPG0303, DELTA-HYDROCORTISONE, 1,2-DEHYDROHYDROCORTISONE, METACORTANDRALONE
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- H02AB07 — PREDNISONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD10441547 · Product
- Active substance
- Opevesostat Tosilate
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 1
SCP126226 · ATC
- Active substance
- Docetaxel
- Substance synonyms
- DOCETAXEL ANHYDROUS
- Route of administration
- INTRAVENOUS INFUSION
- Authorisation status
- Authorised
- ATC code
- L01CD02 — DOCETAXEL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 10
SCP18514 · ATC
- Active substance
- Dexamethasone
- Substance synonyms
- DEXAMETASONE, DEXAMETHASONUM
- Pharmaceutical form
- -
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
A04AA · Product
- Pharmaceutical form
- PHF00244MIG
- Route of administration
- OTHER USE
- Authorisation status
- Authorised
- ATC code
- A04AA — SEROTONIN (5HT3) ANTAGONISTS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP137925 · ATC
- Active substance
- Fludrocortisone Acetate
- Substance synonyms
- 9ALPHA-FLUOROHYDROCORTISONE 21-ACETATE, FLUOHYDROCORTISONE ACETATE
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- H02AA02 — FLUDROCORTISONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1081917 · ATC
- Active substance
- Buclizine Hydrochloride
- Substance synonyms
- Buclizine dihydrochloride
- Route of administration
- OTHER USE
- Authorisation status
- Authorised
- ATC code
- N02BE01 — PARACETAMOL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
R06A · Product
- Pharmaceutical form
- -
- Route of administration
- OTHER USE
- Authorisation status
- Authorised
- ATC code
- R06A — ANTIHISTAMINES FOR SYSTEMIC USE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
H02A · Product
- Pharmaceutical form
- -
- Route of administration
- OTHER USE
- Authorisation status
- Authorised
- ATC code
- H02A — CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
A04AD · Product
- Pharmaceutical form
- PHF00008MIG
- Route of administration
- OTHER USE
- Authorisation status
- Authorised
- ATC code
- A04AD — OTHER ANTIEMETICS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08065MIG · Substance
- Active substance
- Hydrocortisone
- Pharmaceutical form
- POWDER FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08065MIG · Substance
- Active substance
- Hydrocortisone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08065MIG · Substance
- Active substance
- Hydrocortisone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- 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
- 126 East Lincoln Avenue, P. O. Box 2000 P. O. Box 2000
- City
- Rahway
- Postcode
- 07065-4607
- Country
- United States
Scientific contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Fariba Jafari
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Fariba Jafari
Third parties 6
| Organisation | City, country | Duties |
|---|---|---|
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Parexel International Corp. ORG-100007310
|
Auburndale, United States | Other |
| Clario ORL-000013639
|
Philadelphia, United States | E-data capture |
| Roche CDx CAP - CLIA Laboratory ORL-000013673
|
United States | Laboratory analysis |
| Clario ORL-000013638
|
Philadelphia, United States | Other |
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Interactive response technologies (IRT) |
Locations
7 EU/EEA countries · 30 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 36 | 6 |
| Germany | Ongoing, recruiting | 14 | 4 |
| Ireland | Ongoing, recruiting | 9 | 3 |
| Italy | Ongoing, recruiting | 19 | 5 |
| Netherlands | Ongoing, recruiting | 12 | 3 |
| Poland | Ongoing, recruiting | 23 | 4 |
| Spain | Ongoing, recruiting | 32 | 5 |
| Rest of world
United States, Canada, Chile, Australia, Taiwan, Turkey, United Kingdom, Brazil, Israel, Argentina, Korea, Republic of, New Zealand
|
— | 216 | — |
Investigational sites
Hospices Civils De Lyon
Oncologie médicale, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Centre Hospitalier De La Cote Basque
Oncologie médicale, 13 Avenue Interne Jacques Loeb, 64100, Bayonne
Institut De Cancerologie De L Ouest
Oncologie médicale, 15 Rue Andre Boquel, 49100, Angers
Centre Oscar Lambret
Oncologie médicale, 3 Rue Frederic Combemale, 59000, Lille
Institut Gustave Roussy
Oncologie médicale, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut Bergonie
Oncologie médicale, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Universitaetsklinikum Jena KöR
Klinik und Poliklinik für Urologie, Am Klinikum 1, Lobeda, Jena
Universitaetsklinikum Heidelberg AöR
Nationales Centrum für Tumorerkrankungen (NCT) - Klinik f. Medizinische Onkologie, Im Neuenheimer Feld 460, Neuenheim, Heidelberg
University Medical Center Hamburg-Eppendorf
Department of Internal Medicine II, Oncological Clinical Trials Center, Martinistrasse 52, Eppendorf, Hamburg
Universitaetsklinikum Ulm AöR
Klinik für Urologie und Kinderurologie, Albert-Einstein-Allee 23, Eselsberg, Ulm
Beaumont Hospital
Oncology, Beaumont Road, Beaumont, Dublin 9
St Vincent's University Hospital
Oncology, Elm Park Merrion Road, D04 T6F4, Dublin 4
Tallaght University Hospital
Oncology, Tallaght, D24 NR0A, Dublin 24
Azienda Ospedaliera Universitaria Federico II Di Napoli
Unità di terapie innovative, Via Sergio Pansini 5, 80131, Naples
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
SCDU Oncologia Medica, Regione Gonzole 10, 10043, Orbassano
Fondazione IRCCS Istituto Nazionale Dei Tumori
Struttura Semplice Dipartimentale Genitourinaria, Dipartimento di Oncologia Medica, Via Giacomo Venezian 1, 20133, Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Dipartimento Scienze Mediche e Chirurgiche, Largo Francesco Vito 1, 00168, Rome
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
S.C. Clinical Trial Center e Studi di Fase I ; U.O. Oncologia, Piazzale Spedali Civili 1, 25123, Brescia
Ziekenhuis Nij Smellinghe
Internal Medicine, Compagnonsplein 1, 9202 NN, Drachten
Radboud universitair medisch centrum Stichting
Department of Medical Oncology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Ziekenhuis Gelderse Vallei Stichting
Internal Medicine, Willy Brandtlaan 10, 6716 RP, Ede Gld
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Oddział Onkologii Klinicznej z Pododdziałem Chemioterapii Jednodniowej, Ul. Tytusa Chalubinskiego 7, 75-581, Koszalin
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Oddzial Badan Wczesnych Faz, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Uniwersytecki Szpital Kliniczny W Poznaniu
Oddział Kliniczny Onkologii Klinicznej i Doświadczalnej, Ul. Augustyna Szamarzewskiego 84, 60-569, Poznan
Uniwersyteckie Centrum Kliniczne
CWBK UCK Ośrodek Badań Klinicznych Wczesnych Faz, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
University Hospital Virgen Del Rocio S.L.
Oncología, Avenida De Manuel Siurot S/n, 41013, Sevilla
Institut Catala D'oncologia
Oncología Médica, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario 12 De Octubre
Oncología, Avenida De Cordoba Sn, 28041, Madrid
Hospital Clinico San Carlos
Oncología, Calle Del Profesor Martín Lagos S/n, 28040, Madrid
Hospital Universitario Ramon Y Cajal
Oncología, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
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 |
|---|---|---|---|---|---|
| France | 2025-10-16 | 2025-10-22 | |||
| Germany | 2025-09-05 | 2025-09-29 | |||
| Ireland | 2026-01-21 | 2026-03-10 | |||
| Italy | 2025-09-16 | 2025-09-30 | |||
| Netherlands | 2025-08-19 | 2026-01-08 | |||
| Poland | 2025-09-03 | 2025-09-05 | |||
| Spain | 2025-08-12 | 2025-08-20 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 47 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-516036-94_SM09-RFI007_for pub | 05R |
| Protocol (for publication) | D1_Protocol_Master U01_2024-516036-94_IN_for pub | 00R |
| Protocol (for publication) | D4_Subject questionnaire_Handheld_EN_IN_for pub | 1.00 |
| Protocol (for publication) | D4_Subject questionnaire_Tablet_EN_IN_for pub | 1.00 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_DEU_EN_IN-RFI009_for pub | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_ESP_ES_IN_for pub | 5R |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_FRA_FR_IN-RFI005_for pub | 28MAY2025 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_IRL_EN_IN_for pub | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_ITA_EN_SM09_for pub | 12JAN2026 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_NLD_EN_IN_for pub | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_POL_PL_IN_for pub | 1.00 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_DEU_DE_IN_for pub | 01.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_IRL_EN_IN_for pub | 01.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_NLD_NL_SM06-RFI002_for pub | v3-0 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Summary PIS_IRL_EN_SM03_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_DEU_DE_IN-RFI013_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_ESP_ES_IN_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_NLD_NL_IN_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_FRA_FR_SM09-RFI002_for pub | AM02_v2-00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main adult consent_FRA_FR_NSM03_for pub | AM02v2.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_DEU_DE_NSM02_for pub | AM02v2.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_ESP_ES_NSM07_for pub | AM02v2.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_IRL_EN_NSM04_for pub | AM02v2.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_ITA_IT_NSM05_for pub | AM02v2.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_NLD_NL_NSM08_for pub | AM02v2.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_POL_PL_NSM06_for pub | AM02v2.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main data privacy_ITA_IT_IN_for pub | 03MAR2025 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_add crossborder_DEU_DE_IN-RFI009_for pub | 0.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_DILI sample_ITA_IT_IN_for pub | 03MAR2025 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_IRL_EN_IN_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire_DEU_DE_IN-RFI009_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnancy follow-up_POL_PL_IN-RFI008_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner data privacy_ITA_IT_IN-RFI004_for pub | 21MAY2025 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner_ESP_ES_IN_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner_ITA_IT_IN-RFI004_for pub | 21MAY2025 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC RSI_Abiraterone JANSSEN-CILAG LTD_IN_for pub | 06SEP2022 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC RSI_Docetaxel SEACROSS PHARMACEUTICALS LTD_IN_for pub | 02AUG2023 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC RSI_Enzalutamide Astellas Pharma_IN_for pub | 27JUN2024 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC RSI_Prednisolone AMDIPHARM MERCURY_IN_for pub | 12APR2024 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC RSI_Prednisone ACIS ARZNEIMITTEL GMBH_IN_for pub | 01MAR2022 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-516036-94_DEU_DE_IN_for pub | 2.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-516036-94_ESP_ES_IN_for pub | 2.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-516036-94_FRA_FR_IN_for pub | 2.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-516036-94_IN_for pub | 2.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-516036-94_ITA_IT_IN_for pub | 2.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-516036-94_NLD_NL_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-516036-94_POL_PL_IN_for pub | 2.0 |
Application history
19 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-17 | Netherlands | Acceptable with conditions 2025-07-07
|
2025-07-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-07-14 | Acceptable with conditions | 2025-08-14 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-07-15 | Acceptable with conditions | 2025-08-27 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-16 | Acceptable with conditions | 2025-08-14 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-17 | Acceptable with conditions | 2025-08-28 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-07-17 | Netherlands | Acceptable with conditions | 2025-08-18 |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-07-21 | Acceptable with conditions | 2025-07-28 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-09-04 | Netherlands | Acceptable with conditions | 2025-09-04 |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-09-18 | Acceptable with conditions | 2025-10-23 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-12-02 | Netherlands | Acceptable with conditions | 2025-12-05 |
| 11 | SUBSTANTIAL MODIFICATION | SM-9 | 2026-01-16 | Netherlands | Acceptable 2026-04-28
|
2026-04-28 |
| 12 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-05-04 | Acceptable 2026-04-28
|
2026-05-04 | |
| 13 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-05-04 | Acceptable 2026-04-28
|
2026-05-04 | |
| 14 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-05-04 | Acceptable 2026-04-28
|
2026-05-04 | |
| 15 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2026-05-04 | Acceptable 2026-04-28
|
2026-05-04 | |
| 16 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2026-05-04 | Acceptable 2026-04-28
|
2026-05-04 | |
| 17 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2026-05-04 | Acceptable 2026-04-28
|
2026-05-04 | |
| 18 | NON SUBSTANTIAL MODIFICATION | NSM-8 | 2026-05-04 | Netherlands | Acceptable 2026-04-28
|
2026-05-04 |
| 19 | SUBSTANTIAL MODIFICATION | SM-10 | 2026-05-04 | Acceptable | 2026-05-21 |