Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruitment ended
Participants planned
101
Countries
9
Sites
38
Solid tumors
To monitor the safety and tolerability of study intervention(s)
Key facts
- Sponsor
- Pfizer Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 20 Sep 2022 → ongoing
- Decision date (initial)
- 2024-08-30
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Pfizer
External identifiers
- EU CT number
- 2023-509408-13-00
- EudraCT number
- 2021-004395-34
- ClinicalTrials.gov
- NCT05203172
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Others
To monitor the safety and tolerability of study intervention(s)
Secondary objectives 1
- Not applicable
Conditions and MedDRA coding
Solid tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065143 | Malignant solid tumour | 10029104 |
| 21.1 | LLT | 10065147 | Malignant solid tumor | 10029104 |
| 21.0 | LLT | 10049280 | Solid tumour | 10029104 |
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Any participant who is receiving study intervention and deriving clinical benefit (as determined by the principal investigator) in an encorafenib/binimetinib Parent Study, with no ongoing NCI CTCAE version 4.03 Grade ≥3 or intolerable Grade 2 AEs considered to be related to study treatment.
- Participants must agree to follow the reproductive criteria as outlined in Appendix 4 (Section 10.4.1 for males and Section 10.4.2 for females) of the applicable Encorafenib/Binimetinib Continuation Sub-Study Protocol.
- Participants who are willing and able to comply with all scheduled visits, treatment plan, and other study procedures as outlined in the applicable Encorafenib/Binimetinib Continuation Sub-Study Protocol.
- Capable of giving signed informed consent as described in Appendix 1, Section 10.1.3, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
Exclusion criteria 1
- Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- AEs leading to permanent discontinuation of study interventiona
- All SAEs
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 12
Zelboraf 240 mg film-coated tablets
PRD2154737 · Product
- Active substance
- Vemurafenib
- Substance synonyms
- RO5185426, PLX4032, N-(3-((5-(4-CHLOROPHENYL)-1H-PYRROLO(2,3-B)PYRIDIN-3-YL)CARBONYL)-2,4- DIFLUOROPHENYL)PROPANE-1-SULFONAMIDE
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1920 mg milligram(s)
- Max total dose
- 1920 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EC01 — -
- Marketing authorisation
- EU/1/12/751/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Erbitux 5 mg/mL solution for infusion
PRD327539 · Product
- Active substance
- Cetuximab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 500 mg/m2 milligram(s)/sq. meter
- Max total dose
- 60000 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FE01 — -
- Marketing authorisation
- EU/1/04/281/003
- MA holder
- MERCK EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Study-specific packaging and labelling in accordance with Annex 13 and country requirements.
PRD11132188 · Product
- Active substance
- Ribociclib
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 1095000 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- PFIZER INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD11132175 · Product
- Active substance
- Ribociclib
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 1095000 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- PFIZER INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD11132181 · Product
- Active substance
- Ribociclib
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 1095000 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- PFIZER INC.
- Paediatric formulation
- No
- Orphan designation
- No
Mektovi 15 mg film-coated tablets
PRD6728141 · Product
- Active substance
- Binimetinib
- Substance synonyms
- MEK162
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 90 mg milligram(s)
- Max total dose
- 164250 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EE03 — -
- Marketing authorisation
- EU/1/18/1315/001
- MA holder
- PIERRE FABRE MEDICAMENT
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Study-specific packaging and labelling in accordance with Annex 13 and country requirements.
Mektovi 15 mg film-coated tablets
PRD6744227 · Product
- Active substance
- Binimetinib
- Substance synonyms
- MEK162
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 90 mg milligram(s)
- Max total dose
- 164250 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EE03 — -
- Marketing authorisation
- EU/1/18/1315/002
- MA holder
- PIERRE FABRE MEDICAMENT
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Study-specific packaging and labelling in accordance with Annex 13 and country requirements.
PRD11156280 · Product
- Active substance
- Encorafenib
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 450 mg milligram(s)
- Max total dose
- 821250 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- PFIZER INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD6728290 · Product
- Active substance
- Encorafenib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 450 mg milligram(s)
- Max total dose
- 821250 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EC03 — -
- Marketing authorisation
- EU/1/18/1314/001
- MA holder
- PIERRE FABRE MEDICAMENT
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Study-specific packaging and labelling in accordance with Annex 13 and country requirements.
PRD6744630 · Product
- Active substance
- Encorafenib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 450 mg milligram(s)
- Max total dose
- 821250 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EC03 — -
- Marketing authorisation
- EU/1/18/1314/004
- MA holder
- PIERRE FABRE MEDICAMENT
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Study-specific packaging and labelling in accordance with Annex 13 and country requirements.
PRD6744394 · Product
- Active substance
- Encorafenib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 450 mg milligram(s)
- Max total dose
- 821250 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EC03 — -
- Marketing authorisation
- EU/1/18/1314/003
- MA holder
- PIERRE FABRE MEDICAMENT
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Study-specific packaging and labelling in accordance with Annex 13 and country requirements.
PRD6728382 · Product
- Active substance
- Encorafenib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 450 mg milligram(s)
- Max total dose
- 821250 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EC03 — -
- Marketing authorisation
- EU/1/18/1314/002
- MA holder
- PIERRE FABRE MEDICAMENT
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Study-specific packaging and labelling in accordance with Annex 13 and country requirements.
Comparator 2
SUB167136 · Substance
- Active substance
- Pembrolizumab
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 7000 mg milligram(s)
- Max total dose
- 7000 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Study-specific packaging and labelling in accordance with Annex 13 and country requirements.
SUB122750 · Substance
- Active substance
- Nivolumab
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 11800 mg milligram(s)
- Max total dose
- 11800 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Study-specific packaging and labelling in accordance with Annex 13 and country requirements
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pfizer Inc.
- Sponsor organisation
- Pfizer Inc.
- Address
- 66 Hudson Boulevard East
- City
- New York
- Postcode
- 10001-2189
- Country
- United States
Scientific contact point
- Organisation
- Pfizer Inc.
- Contact name
- Clinical Medical Lead
Public contact point
- Organisation
- Pfizer Inc.
- Contact name
- Clinical Medical Lead
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| PPD Development LP ORG-100011560
|
Wilmington, United States | Other, Code 5 |
Locations
9 EU/EEA countries · 38 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ongoing, recruiting | 3 | 2 |
| France | Ended | 2 | 1 |
| Germany | Ongoing, recruiting | 7 | 3 |
| Greece | Authorised, recruitment pending | 4 | 1 |
| Hungary | Ongoing, recruiting | 5 | 4 |
| Italy | Ongoing, recruiting | 25 | 9 |
| Netherlands | Ongoing, recruiting | 2 | 3 |
| Portugal | Ongoing, recruiting | 2 | 2 |
| Spain | Ongoing, recruiting | 21 | 13 |
| Rest of world
Ukraine, United States, Canada, Brazil, United Kingdom, South Africa, Israel, Russian Federation, Australia, Korea, Republic of, Turkey, Mexico
|
— | 30 | — |
Investigational sites
Vseobecna Fakultni Nemocnice V Praze
Dermatovenerologická klinika, U Nemocnice 499/2, Nove Mesto, Prague
University Hospital Olomouc
Onkologická klinika, Zdravotniku 248/7, 779 00, Olomouc
Charite Universitaetsmedizin Berlin KöR
N/A, Chariteplatz 1, Mitte, Berlin
Otto Von Guericke Universitaet Magdeburg
N/A, Leipziger Strasse 44, Leipziger Str., Magdeburg
Universitaetsklinikum Tuebingen AöR
N/A, Liebermeisterstrasse 25, Innenstadt, Tuebingen
Laiko General Hospital Of Athens
First Department of Internal Medicine, Agiou Thoma (goudi) 17, 115 27, Athens
Semmelweis University
Bor-/ Nemikortani es Boronkologiai Klinika, Maria Utca 41, 1085, Budapest VIII
Orszagos Onkologiai Intezet
Oncodermatology, Rath Gyorgy Utca 7-9, Kerulet, Budapest XII
University Of Debrecen
Klinikai Központ - Department of Dermatology, Nagyerdei Korut 98, 4032, Debrecen
University Of Pecs
Bor-/ Nemikortani es Onkodermatologiai Klinika, Akac Utca 1, 7632, Pecs
Azienda Ospedaliera Di Perugia
Department of medical oncology, Via Gerardo Dottori 1, 06132, Perugia
IRCCS Istituto Nazionale Tumori Fondazione Pascale
N/A, Via Mariano Semmola 52, 80131, Naples
IRCCS Istituto Nazionale Tumori Fondazione Pascale
S.C. Onc. Clinica Sperimentale Del Melanoma – Immunoterapia e Terapie Innovative, Via Mariano Semmola 52, 80131, Naples
Istituto Europeo Di Oncologia S.r.l.
Oncology Melanoma, Sarcoma and Rare Tumors, Via Giuseppe Ripamonti 435, 20141, Milan
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Oncology and Hematology, Via Pietro Albertoni 15, 40138, Bologna
Istituto Tumori Bari Giovanni Paolo II
N/A, Viale Orazio Flacco 65, 70124, Bari
IRCCS- Regina Elena National Cancer Institute
N/A, 53 Via Elio Chianesi, 00144, Roma
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
GIC cutaneous tumors, Strada Provinciale 142 Orba Km 3,95, 10060, Candiolo
Istituto Oncologico Veneto
Oncologia 2, Via Gattamelata 64, 35128, Padova
Isala Klinieken Stichting
N/A, Dokter Van Heesweg 2, 8025 AB, Zwolle
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
N/A, Plesmanlaan 121, 1066 CX, Amsterdam
Radboud universitair medisch centrum / RADBOUDUMC
N/A, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Oncology, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
Medical Oncology Department, Rua Professor Lima Basto, 1099-023, Lisbon
Hospital Universitario Marques De Valdecilla
Servicio de Oncologia Medica, Avenida Valdecilla Sn, 39008, Santander
Hospital Teresa Herrera C.H.U.A.C.
Servicio Oncología Médica, C/ Xubias de Abaixo, s/n, A Coruna
Hospital Universitari Vall D Hebron
Servicio de Oncologia Medica, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Puerta De Hierro De Majadahonda
Consultas Externas de Oncologia, Calle De Manuel De Falla 1, 28222, Majadahonda
Institut Catala D'oncologia
Oncologia Médica, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Clinic De Barcelona
ICMHO Oncologia Medica, Calle Villarroel 170, 08036, Barcelona
Hospital Germans Trias I Pujol
Servicio de Oncologia Medica, Carretera Canyet 1a Planta, 08916, Badalona
Hospital Universitario Hm Sanchinarro
Centro integral Oncologico Clara Campal, Calle Ona 10, 28050, Madrid
Hospital Universitario 12 De Octubre
Oncologia, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitari Vall D Hebron
Servicio de Oncología Médica, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Servicio de Oncologia, Avinguda De L'alcalde Rovira Roure 80, 25196, Lleida
Hospital Universitario Central De Asturias
Servicio de Oncología, Avenida De Roma S/n, 33011, Oviedo
Hospital Universitario Regional De Malaga
Servicio de Oncología, Avenida De Carlos De Haya S/N, 29010, Malaga
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 |
|---|---|---|---|---|---|
| Czechia | 2023-12-08 | 2024-01-04 | |||
| France | 2022-09-23 | 2025-09-19 | 2022-10-07 | 2024-09-26 | |
| Germany | 2023-12-19 | 2023-12-27 | |||
| Hungary | 2023-05-19 | 2023-06-07 | |||
| Italy | 2022-10-07 | 2022-11-02 | |||
| Netherlands | 2022-12-21 | 2022-12-23 | |||
| Portugal | 2023-11-24 | 2023-12-07 | |||
| Spain | 2022-09-20 | 2022-09-21 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 144 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_1_Master Protocol_2023-509408-13-00_C4221026_EN_clean_public | AM1 |
| Protocol (for publication) | D1_1_Master Protocol_2023-509408-13-00_C4221026_GR_public | AM1 |
| Protocol (for publication) | D1_10_Protocol_2023-509408-13-00_Sub-Study C4221016C and C4221023C_GR_public | AM1 |
| Protocol (for publication) | D1_10_Protocol_Sub-Study C4221016C and C4221023C_2023-509408-13-00_C4221026_EN_clean_public | AM1 |
| Protocol (for publication) | D1_2_List of sub-studies_Master Protocol_2023-509408-13-00_C4221026_EN | AM1 |
| Protocol (for publication) | D1_2_List of sub-studies_Master Protocol_2023509408-13-00_C4221026_GR_public | AM1 |
| Protocol (for publication) | D1_3_Protocol Sub-Study C4211001C_C4211003C_2023-509408-13-00_C4221026_EN_clean_public | AM1 |
| Protocol (for publication) | D1_4_Protocol_Sub-Study C4221003C_6C_13C_2023-509408-13-00_C4221026_EN_clean_public | AM1 |
| Protocol (for publication) | D1_5_Protocol_Sub-Study C4221005C_2023-509408-13-00_C4221026_EN_clean_public | AM1 |
| Protocol (for publication) | D1_6_Protocol_Sub-Study C4221008C_2023-509408-13-00_C4221026_EN_clean_public | AM1 |
| Protocol (for publication) | D1_7_Protocol_Sub-Study C4221009C_GE 2 01C_2023-509408-13-00_C4221026_EN_clean_public | AM1 |
| Protocol (for publication) | D1_8_Protocol_Sub-Study _C4221010C_2023-509408-13-00_C4221026_Sanitized | 1 |
| Protocol (for publication) | D1_9_Protocol_Sub-Study C4221004C_2023-509408-13-00_C4221026_EN_clean_public | AM1 |
| Protocol (for publication) | D1_PACL 1_C4211001C-C4211003C Sub-Study_2023-509408-13-00_C4221026_EN_public | 1 |
| Protocol (for publication) | D1_PACL 1_C4221009C Sub-Study_2023-509408-13-00_C4221026_EN_public | NA |
| Protocol (for publication) | D1_PACL 1_C4221010C Sub-Study_2023-509408-13-00_C4221026_EN_public | NA |
| Protocol (for publication) | D1_PACL 1_Master Protocol_2023-509408-13-00_C4221026_EN_public | NA |
| Protocol (for publication) | D1_PACL 2_C4211001C-C4211003C Sub-Study_2023-509408-13-00_C4221026_EN_public | NA |
| Protocol (for publication) | D1_PACL 2_C4221009C Sub-Study_2023-509408-13-00_C4221026_EN_public | NA |
| Protocol (for publication) | D1_PACL 2_C4221010C Sub-Study_2023-509408-13-00_C4221026_EN_public | NA |
| Protocol (for publication) | D1_PACL 2_Master Protocol_2023-509408-13-00_C4221026_EN_public | NA |
| Protocol (for publication) | D1_PACL_C4221003C-C4221006C-C4221013C Sub-Study_2023-509408-13-00_C4221026_EN_public | NA |
| Protocol (for publication) | D1_PACL_C4221005C Sub-Study_2023-509408-13-00_C4221026_EN_public | NA |
| Protocol (for publication) | D1_PACL_CZ_2023-509408-13-00_C4221026_EN_public | NA |
| Recruitment arrangements (for publication) | C4221026_blank file Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent Procedure_C4221026_CZ_CS-EN_Public | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_C4221026_DE_EN_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_C4221026_ES_EN_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_C4221026_GR_EN_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_C4221026_HU_EN_Public | NA |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_C4221026_PT_EN_Public | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Informed Consent Form_C4221026_IT_EN_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Informed Consent_C4221026_NL_EN_Public | N/A |
| Recruitment arrangements (for publication) | K2_Study_Information_Card_C4221026_GR_EL_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_Main ICD_C4221016 Sub Study_C4221010C_FR_FR_Public | 1 |
| Subject information and informed consent form (for publication) | L1_Main ICD_C4221026 Sub Study C4211001C-C4211003C _IT_IT_Public | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_Main ICD_C4221026 Sub Study C4211001C-C4211003C_NL_NL_Public | 4.4.0 |
| Subject information and informed consent form (for publication) | L1_Main ICD_C4221026 substudy C4221003C C4221006C C4221013C_ES_ES_Public | 2.3.0 |
| Subject information and informed consent form (for publication) | L1_Main ICD_C4221026 substudy C4221004C_CZ_CS_Public | 1.2.0 |
| Subject information and informed consent form (for publication) | L1_Main ICD_C4221026 substudy C4221004C_HU_HU_Public | 1.2.0 |
| Subject information and informed consent form (for publication) | L1_Main ICD_C4221026 substudy C4221004C_PT_PT_Public | 1.1.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF_C4221026_GR_EL_Public | 1.0 |
| Subject information and informed consent form (for publication) | L10_ ICD Scout_C4221026_ES_ES_Public | 2.0 |
| Subject information and informed consent form (for publication) | L10_PPRIF_C4221026_Sub Study C4221016C-C4221023C_IT_IT_Public | N/A |
| Subject information and informed consent form (for publication) | L11_ICD Addendum_C4221026_Substudy C4221004C_ES_ES_Public | 1 |
| Subject information and informed consent form (for publication) | L11_Main ICD Addendum_C4221026_Sub study C4221004_IT_IT_Public | N/A |
| Subject information and informed consent form (for publication) | L12_Main ICD Addendum_C4221026_Sub study C4221005C_IT_IT_Public | N/A |
| Subject information and informed consent form (for publication) | L12_Main ICD_C4221026 substudy C4221016C C4221023C_ES_ES_Public | NA |
| Subject information and informed consent form (for publication) | L13_ICD Addendum_C4221026_Substudy C4221004C_ES_ES_Public | NA |
| Subject information and informed consent form (for publication) | L13_Main ICD Addendum_C4221026_Sub study C4221008C_IT_IT_Public | N/A |
| Subject information and informed consent form (for publication) | L13_PPRIF_C4221026 substudy C4221016C C4221023C_ES_ES_Public | 1.0 |
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| Subject information and informed consent form (for publication) | L16_ICD Addendum_C4221026_Substudy C4221009C W00090GE201C_ES_ES_Public | NA |
| Subject information and informed consent form (for publication) | L1a_Main ICD _C4221026_DE_DE_Public | 1.1.0 |
| Subject information and informed consent form (for publication) | L1b_Main ICD_C4221016_DE_SB_Public | 1.1.0 |
| Subject information and informed consent form (for publication) | L2_Main ICD_C4221026 Sub Study C4221004C_IT_IT_Public | 1.1.0 |
| Subject information and informed consent form (for publication) | L2_Main ICD_C4221026 Sub Study C4221004C_NL_NL_Public | 1.3.0 |
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| Subject information and informed consent form (for publication) | L2_PPRIF_C4221026 Sub Study C4221004_DE_DE_Public | 1.1.0 |
| Subject information and informed consent form (for publication) | L2_PPRIF_C4221026 substudy C4221003C C4221006C C4221013C_ES_ES_Public | 1.0 |
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| Subject information and informed consent form (for publication) | L2_PPRIF_C4221026 substudy C4221004C_HU_HU_Public | 4.1 |
| Subject information and informed consent form (for publication) | L2_PPRIF_C4221026 substudy C4221004C_PT_PT_Public | 1.1.0 |
| Subject information and informed consent form (for publication) | L3_Main ICD addendum_C4221026 substudy C4221004C_PT_PT_Public | NA |
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| Subject information and informed consent form (for publication) | L3_Study Information Card_C4221026_HU_HU_Public | 1.0 |
| Subject information and informed consent form (for publication) | L3a_Main ICD Addendum_C4221026_Sub study C4221004_DE_DE_Public | N/A |
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| Subject information and informed consent form (for publication) | L4_Main ICD_C4221026 Sub Study C4221008C_IT_IT_Public | 1 |
| Subject information and informed consent form (for publication) | L4_Main ICD_C4221026 substudy C4221016-C4221023_HU_HU_Public | 3.0 |
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| Subject information and informed consent form (for publication) | L4_PRIF_C4221026 Sub Study C4211001-C4211003C_NL_NL_Public | 4.1.0 |
| Subject information and informed consent form (for publication) | L5_1_Main ICD_C4221026 substudy C4221016-C4221023_CZ_CS_Public | NA |
| Subject information and informed consent form (for publication) | L5_Main ICD_C4221026 substudy C4221004C_ES_ES_ Public | 1.1.0 |
| Subject information and informed consent form (for publication) | L5_PPRIF_C4221026 Sub Study C4221004C_IT_IT_Public | 4.1.0 |
| Subject information and informed consent form (for publication) | L5_PPRIF_C4221026 substudy C4221016_HU_HU_Public | 5.0 |
| Subject information and informed consent form (for publication) | L5_PRIF_C4221026 Sub Study C4221004C_NL_NL_Public | 4.1.0 |
| Subject information and informed consent form (for publication) | L6_1_Main ICD Appendix A_C4221026 substudy C4221016-C4221023_CZ_CS_Public | NA |
| Subject information and informed consent form (for publication) | L6_Main ICD Addendum_C4221026 substudy C4221004C_ES_ES_Public | 1 |
| Subject information and informed consent form (for publication) | L6_Main ICD Addendum_C4221026 substudy C4221004C_HU_HU_Public | 2.0 |
| Subject information and informed consent form (for publication) | L6_PPRIF_C4221026 Sub Study C4211001C-C4211003C_IT_IT_Public | 4.1.0 |
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| Subject information and informed consent form (for publication) | L7_1_Main ICD Appendix B_C4221026 substudy C4221016-C4221023_CZ_CS_Public | NA |
| Subject information and informed consent form (for publication) | L7_Addendum ICD_C4221026_Sub Study_C4211001C_NL_NL_Public | N/A |
| Subject information and informed consent form (for publication) | L7_List of ICDs and recruitment materials_C4221026_HU_HU_Public | NA |
| Subject information and informed consent form (for publication) | L7_PPRIF_C4221026 Sub Study C4221005C_IT_IT_Public | 4.1.0 |
| Subject information and informed consent form (for publication) | L7_PPRIF_C4221026 substudy C4221004C_ES_ES_Public | 1.0 |
| Subject information and informed consent form (for publication) | L8_1_PPRIF_C4221026 substudy C4221016-C4221023_CZ_CS_Public | NA |
| Subject information and informed consent form (for publication) | L8_Addendum ICD_C4221026_Sub Study C4221008C_NL_NL_Public | N/A |
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| Subject information and informed consent form (for publication) | L8_PPRIF_C4221026 Sub Study C4221008C_IT_IT_Public | 4.1.0 |
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| Subject information and informed consent form (for publication) | L9_1_Main ICD_C4221026_Sub Study C4221016C-C4221023C_IT_IT_Public | N/A |
| Subject information and informed consent form (for publication) | L9_PPRIF_C4221026 substudy C4221008C_ES_ES_Public | 1.0 |
| Subject information and informed consent form (for publication) | L9_Privacy Supplement_C4221026 substudy C4221016-C4221023_CZ_CS_Public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC _Vemurafenib _2023-509408-13-00_C4221026C4221026_EN | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Cetuximab_2023-509408-13-00_C4221026_EN | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Nivolumab_2023-509408-13-00_C4221026_EN_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Pembrolizumab_2023-509408-13-00_C4221026_EN_public | 1 |
| Synopsis of the protocol (for publication) | D2_Protocol Synopsis_Master Protocol_2023-509408-13-00_C4221026_EN_public | final |
| Synopsis of the protocol (for publication) | D2_Protocol Synopsis_Master Protocol_2023-509408-13-00_C4221026_GR_public | AM1 |
| Synopsis of the protocol (for publication) | D2_Protocol Synopsis_Sub Study_C4221009C_2013-509408-13-00_C4221026_EN_public | final |
| Synopsis of the protocol (for publication) | D2_Protocol Synopsis_Sub-Study C4221016C and C4221023C_2023-509408-13-00_C4221026_CZ_public | AM1 |
| Synopsis of the protocol (for publication) | D2_Protocol Synopsis_Sub-Study C4221016C and C4221023C_2023-509408-13-00_C4221026_ES_public | AM1 |
| Synopsis of the protocol (for publication) | D2_Protocol Synopsis_Sub-Study C4221016C and C4221023C_2023-509408-13-00_C4221026_FR_public | AM1 |
| Synopsis of the protocol (for publication) | D2_Protocol Synopsis_Sub-Study C4221016C and C4221023C_2023-509408-13-00_C4221026_HU_public | AM1 |
| Synopsis of the protocol (for publication) | D2_Protocol Synopsis_Sub-Study C4221016C and C4221023C_2023-509408-13-00_C4221026_IT_public | AM1 |
| Synopsis of the protocol (for publication) | D2_Protocol Synopsis_Sub-Study C4221016C and C4221023C_2023-509408-13-00_C4221026_NL_public | AM1 |
| Synopsis of the protocol (for publication) | D2_Protocol Synopsis_Sub-Study C4221016C and C4221023C_2023-509408-13-00_C4221026_PT_public | AM1 |
| Synopsis of the protocol (for publication) | D2_Protocol Synopsis_Sub-Study C4221016C and C4221023C_2023-509408-13-00_GR_public | AM1 |
| Synopsis of the protocol (for publication) | D2_Protocol Synopsis_Sub-Study_C4221003C_2023-509408-13-00_C4221026_EN_public | final |
| Synopsis of the protocol (for publication) | D2_Protocol Synopsis_Sub-Study_C4221004C_2023-509408-13-00_C4221026_EN_public | final |
| Synopsis of the protocol (for publication) | D2_Protocol Synopsis_Sub-Study_C4221005C_2023-509408-13-00_C4221026_EN_public | final |
| Synopsis of the protocol (for publication) | D2_Protocol Synopsis_Sub-Study_C4221008C_2023-509408-13-00_C4221026_EN_public | final |
| Synopsis of the protocol (for publication) | D2_Protocol-Synopsis_Sub-Study_C4211001C_2023-509408-13-00_C4221026_EN_public | final |
| Synopsis of the protocol (for publication) | D3_Protocol Synopsis_Master Protocol_2023-509408-13-00_C4221026_CZ_public | final |
| Synopsis of the protocol (for publication) | D3_Protocol Synopsis_Master Protocol_2023-509408-13-00_C4221026_ES_public | final |
| Synopsis of the protocol (for publication) | D3_Protocol Synopsis_Master Protocol_2023-509408-13-00_C4221026_FR_public | final |
| Synopsis of the protocol (for publication) | D3_Protocol Synopsis_Master Protocol_2023-509408-13-00_C4221026_HU_public | final |
| Synopsis of the protocol (for publication) | D3_Protocol Synopsis_Master Protocol_2023-509408-13-00_C4221026_IT_public | final |
| Synopsis of the protocol (for publication) | D3_Protocol Synopsis_Master Protocol_2023-509408-13-00_C4221026_NL_public | final |
| Synopsis of the protocol (for publication) | D3_Protocol Synopsis_Master Protocol_2023-509408-13-00_C4221026_PT_public | final |
| Synopsis of the protocol (for publication) | D3_Protocol Synopsis_Sub-Study_C4221003C_2023-509408-13-00_C4221026_ES_public | final |
| Synopsis of the protocol (for publication) | D3_Protocol Synopsis_Sub-Study_C4221004C_2023-509408-13-00_C4221026_CZ_public | final |
| Synopsis of the protocol (for publication) | D3_Protocol Synopsis_Sub-Study_C4221004C_2023-509408-13-00_C4221026_ES_public | final |
| Synopsis of the protocol (for publication) | D3_Protocol Synopsis_Sub-Study_C4221004C_2023-509408-13-00_C4221026_FR_public | final |
| Synopsis of the protocol (for publication) | D3_Protocol Synopsis_Sub-Study_C4221004C_2023-509408-13-00_C4221026_HU_public | final |
| Synopsis of the protocol (for publication) | D3_Protocol Synopsis_Sub-Study_C4221004C_2023-509408-13-00_C4221026_IT_public | final |
| Synopsis of the protocol (for publication) | D3_Protocol Synopsis_Sub-Study_C4221004C_2023-509408-13-00_C4221026_NL_public | final |
| Synopsis of the protocol (for publication) | D3_Protocol Synopsis_Sub-Study_C4221004C_2023-509408-13-00_C4221026_PT_public | final |
| Synopsis of the protocol (for publication) | D3_Protocol Synopsis_Sub-Study_C4221005C_2023-509408-13-00_C4221026_IT_public | final |
| Synopsis of the protocol (for publication) | D3_Protocol Synopsis_Sub-Study_C4221008C_2023-509408-13-00_C4221026_ES_public | final |
| Synopsis of the protocol (for publication) | D3_Protocol Synopsis_Sub-Study_C4221008C_2023-509408-13-00_C4221026_IT_public | final |
| Synopsis of the protocol (for publication) | D3_Protocol Synopsis_Sub-Study_C4221008C_2023-509408-13-00_C4221026_NL_public | final |
| Synopsis of the protocol (for publication) | D3_Protocol Synopsis_Sub-Study_C4221009C_2023-509408-13-00_C4221026_ES_public | final |
| Synopsis of the protocol (for publication) | D3_Protocol Synopsis_Sub-Study_C4221010C_2023-509408-13-00_C4221026_FR_public | final |
| Synopsis of the protocol (for publication) | D3_Protocol-Synopsis_Sub-Study_C4211001C_2023-509408-13-00_C4221026_IT_public | final |
| Synopsis of the protocol (for publication) | D3_Protocol-Synopsis_Sub-Study_C4211001C_2023-509408-13-00_C4221026_NL_public | final |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-15 | Italy | Acceptable 2024-08-27
|
2024-08-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-22 | Italy | Acceptable 2025-03-17
|
2025-03-17 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-03-21 | Acceptable 2025-03-17
|
2025-03-21 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-05-09 | Italy | Acceptable 2025-08-07
|
2025-08-07 |
| 5 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-10-24 | Italy | Acceptable 2026-02-09
|
2026-02-11 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-02-23 | Acceptable 2026-02-09
|
2026-02-23 | |
| 7 | SUBSEQUENT ADDITION OF MSC | APP-7 | 2026-03-16 | Acceptable 2026-02-09
|
2026-04-24 |