Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
700
Countries
10
Sites
70
KRAS/NRAS and BRAF Wildtype Recurrent, Unresectable or Metastatic Colorectal Cancer
1. To compare PFS 2. To compare OS
Key facts
- Sponsor
- Janssen Cilag International
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 4 Feb 2025 → ongoing
- Decision date (initial)
- 2025-01-16
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Safety, Efficacy, Others
1. To compare PFS
2. To compare OS
Conditions and MedDRA coding
KRAS/NRAS and BRAF Wildtype Recurrent, Unresectable or Metastatic Colorectal Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10061451 | Colorectal cancer | 100000004864 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
- IPD plan description
- The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- 1.Have histologically or cytologically confirmed adenocarcinoma of the colon or rectum. Participants must have recurrent, unresectable or metastatic disease
- 2. Determined to have KRAS/NRAS G12, G13, and BRAF V600X (X represents any single amino acid change from the original amino acid) wild type status by local and/or central NGS testing (if available).
- 3. Must have received 1 line of systemic therapy for mCRC, with documented radiographic disease progression on or after one line of either fluoropyrimidine-based and oxaliplatin-based therapy
- 4. 18 years and older with ECOG 0-1 and at least one measurable lesion per RECIST v1.1
- 5. Adequate organ and bone marrow function
- 6. Must be eligible for treatment with FOLFIRI according to respective local regulatory approvals and SoC guidelines
Exclusion criteria 5
- 1. Uncontrolled illness
- 2. history of clinically significant cardiovascular disease
- 3. Participant with known dMMR/MSI-H status who has not received immunotherapy treatments.or HER2 amplified tumor
- 4. Participant with known complete absence of DPD activity.
- 5. Has prior exposure to irinotecan, any agents that target epidermal growth factor receptor (EGFR) or mesenchymal epithelial transition (MET)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- PFS (using RECIST v1.1), as assessed by BICR
- OS
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11078981 · Product
- Active substance
- Amivantamab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 5
SCP29096188 · ATC
- Active substance
- Bevacizumab
- Substance synonyms
- BI 695502, BS-503A, PF-06439535, BP01, HLX04, RHUMAB-VEGF, BEVACIZUMABUM, RHUMAB VEGF
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg/ml milligram(s)/millilitre
- Max total dose
- 0 mg/ml milligram(s)/millilitre
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FG01 — BEVACIZUMAB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Avastin 25 mg/ml concentrate for solution for infusion.
PRD389577 · Product
- Active substance
- Bevacizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg/ml milligram(s)/millilitre
- Max total dose
- 0 mg/ml milligram(s)/millilitre
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FG01 — -
- Marketing authorisation
- EU/1/04/300/002
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
VEGZELMA 25 mg/mL concentrate for solution for infusion
PRD9890813 · Product
- Active substance
- Bevacizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg/ml milligram(s)/millilitre
- Max total dose
- 0 mg/ml milligram(s)/millilitre
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FG01 — -
- Marketing authorisation
- EU/1/22/1667/002
- MA holder
- CELLTRION HEALTHCARE HUNGARY KFT
- MA country
- EU
- 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
- INTRAVENOUS USE
- Max daily dose
- 0 mg/ml milligram(s)/millilitre
- Max total dose
- 0 mg/ml milligram(s)/millilitre
- Max treatment duration
- 1 Week(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
- No
Erbitux 5 mg/mL solution for infusion
PRD327543 · Product
- Active substance
- Cetuximab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg/ml milligram(s)/millilitre
- Max total dose
- 0 mg/ml milligram(s)/millilitre
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FE01 — -
- Marketing authorisation
- EU/1/04/281/005
- MA holder
- MERCK EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Janssen Cilag International
- Sponsor organisation
- Janssen Cilag International
- Address
- Turnhoutseweg 30
- City
- Beerse
- Postcode
- 2340
- Country
- Belgium
Scientific contact point
- Organisation
- Janssen Cilag International
- Contact name
- CTIS Point of Contact
Public contact point
- Organisation
- Janssen Cilag International
- Contact name
- CTIS Point of Contact
Third parties 17
| Organisation | City, country | Duties |
|---|---|---|
| Ventana Medical Systems Inc. ORG-100043193
|
Oro Valley, United States | Other, Laboratory analysis |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Other, Laboratory analysis |
| 4g Clinical LLC ORG-100042775
|
Wellesley, United States | Interactive response technologies (IRT) |
| Myriad RBM Inc. ORG-100045698
|
Austin, United States | Other, Laboratory analysis |
| Fisher Clinical Services GmbH ORG-100012942
|
Allschwil, Switzerland | Other |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | Other |
| Cytel Inc. ORG-100042560
|
Cambridge, United States | Other |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Other, Laboratory analysis |
| Foundation Medicine Inc. ORG-100040457
|
Cambridge, United States | Laboratory analysis |
| Smithers PDS LLC ORG-100040403
|
Gaithersburg, United States | Other, Laboratory analysis |
| Labcorp Development (Asia) Pte Ltd ORG-100050418
|
Singapore, Singapore | Other, Laboratory analysis |
| Bioclinica Inc. ORG-100033079
|
Princeton, United States | Other |
| Icon (Lr) Limited ORG-100042612
|
Dublin 18, Ireland | Other |
| Guardant Health Inc. ORG-100042461
|
Redwood City, United States | Laboratory analysis |
| Clinical Ink Inc. ORG-100042433
|
Winston Salem, United States | Other |
| Continuum Clinical LLC ORG-100045925
|
Washington, United States | Other |
| SGS Belgium ORG-100007917
|
Mechelen, Belgium | Other |
Locations
10 EU/EEA countries · 70 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 18 | 7 |
| France | Ongoing, recruiting | 15 | 3 |
| Germany | Ongoing, recruiting | 10 | 5 |
| Hungary | Ended | 12 | 3 |
| Italy | Ongoing, recruiting | 10 | 8 |
| Netherlands | Ongoing, recruiting | 16 | 5 |
| Poland | Ongoing, recruiting | 21 | 9 |
| Romania | Ongoing, recruiting | 27 | 10 |
| Spain | Ongoing, recruiting | 20 | 15 |
| Sweden | Ongoing, recruiting | 13 | 5 |
| Rest of world
Malaysia, Korea, Republic of, Mexico, Israel, India, Australia, Taiwan, Hong Kong, United States, China, Turkey, Thailand, Brazil, United Kingdom, Canada
|
— | 538 | — |
Investigational sites
CHU Helora
Medical oncology, Rue Ferrer 159 Boite 1, 7100, La Louviere
Institut Jules Bordet
Medical oncology, Mijlenmeersstraat 90, 1070, Anderlecht
Centre Hospitalier Universitaire De Liege
Medical oncology, Avenue De L'hopital 1, 4000, Liege
Algemeen Ziekenhuis Groeninge
Gastro-enterology, President Kennedylaan 4, 8500, Kortrijk
UZ Leuven
Gastro-enterology, Herestraat 49, 3000, Leuven
Antwerp University Hospital
Medical oncology, Drie Eikenstraat 655, 2650, Edegem
Az Maria Middelares Gent
Gastro-enterology, Buitenring-Sint-Denijs 30, 9000, Gent
Sainte Catherine Institut Du Cancer Avignon-Provence
Medical Oncology, 250 Chemin De Baigne Pieds, 84918, Avignon Cedex 9
Centre Hospitalier Universitaire De Bordeaux
Medical Oncology, Avenue De Magellan, 33600, Pessac
Centre Hospitalier Universitaire De Poitiers
Medical Oncology, 2 Rue De La Miletrie, 86000, Poitiers
Charite Universitaetsmedizin Berlin KöR
Med. Klinik m. Schwerpunkt Hämatologie, Onkologie u. Tumorimmunologie, Augustenburger Platz 1, Wedding, Berlin
National Center For Tumor Diseases (NCT) Heidelberg
n/a, Im Neuenheimer Feld 460, Neuenheim, Heidelberg
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
NA, Langenbeckstrasse 1, Oberstadt, Mainz
Krankenhaus Nordwest GmbH
Innere Medizin/Hämatologie/Onkologie, Steinbacher Hohl 2-26, Praunheim, Frankfurt Am Main
Klinikum der Universitaet Muenchen AöR
NA, Marchioninistrasse 15, Hadern, Munich
University Of Szeged
Department of Oncotherapy, Koranyi Fasor 12, 6720, Szeged
University Of Pecs
Department of Oncotherapy, Edesanyak Utja 17, 7624, Pecs
Heves Varmegyei Markhot Ferenc Oktatokorhaz Es Rendelointezet
Department of Oncology, Knezich Karoly Utca 1, 3300, Eger
Humanitas Mirasole S.p.A.
U.O. di Oncologia Medica ed Ematologia, Via Alessandro Manzoni 56, 20089, Rozzano
Istituto Oncologico Veneto
UOC Oncologia 1, Via Gattamelata 64, 35128, Padova
Fondazione IRCCS Istituto Nazionale Dei Tumori
S.C. Oncologia Medica 1, Via Giacomo Venezian 1, 20133, Milan
Azienda Ospedaliero Universitaria Pisana
UOC Oncologia 2, Via Roma 67, 56126, Pisa
Azienda Sanitaria Universitaria Friuli Centrale
Dipartimento di Oncologia, Piazzale Santa Maria Della Misericordia 15, 33100, Udine
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
Oncologia Medica, Strada Provinciale 142 Orba Km 3,95, 10060, Candiolo
Azienda Ospedaliero Universitaria Careggi
SOD Oncologia, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
ARNAS Garibaldi Di Catania
Oncologia Medica, Piazza Santa Maria Di Gesu, 95123, Catania
Stichting Elisabeth-Tweesteden Ziekenhuis
Medical Oncology, Hilvarenbeekseweg 60, 5022 GC, Tilburg
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Medical Oncology, Plesmanlaan 121, 1066 CX, Amsterdam
Radboud universitair medisch centrum Stichting
Medical Oncology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Meander Medisch Centrum
Medical Oncology, Maatweg 3, 3813 TZ, Amersfoort
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Medical Oncology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej
Oddzial Chemioterapii Dziennej, Ul. Terebelska 57/65, 21-500, Biala Podlaska
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Onkologii i Radioterapii, Ul. Wawelska 15, 02-034, Warsaw
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku
Oddzial Onkologii Klinicznej, Ul. Ogrodowa 12, 15-027, Bialystok
Uniwersyteckie Centrum Kliniczne
Klinika Onkologii i Radioterapii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie
Klinika Onkologii I Immunoonkologii, Al. Wojska Polskiego 37, 10-228, Olsztyn
Instytut Centrum Zdrowia Matki Polki
Klinika Onkologii, Ul. Rzgowska 281/289, 93-338, Lodz
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Oddzial Chemioterapii Dziennej, Ul. Wybrzeze Armii Krajowej 15, 44-102, Gliwice
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
Oddzial Chemioterapii i Hematologii Onkologicznej, Ul. Ks. Jozefa Bielawskiego 18, 36-200, Brzozow
Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Klinika Onkologii, Ul. Katowicka 66a, 45-061, Opole
Pelican Impex S.R.L.
Oncologie Medicala, Calea Coposu Corneliu 14a-14b, 410469, Oradea
Delta Health Care S.R.L.
Oncologie, Strada Caramfil G. Nicolae Nr 85a, 014142, Bucharest
Institutul Regional De Oncologie Iasi
Oncologie Medicala, Strada G-Ral Berthelot 2-4, 700483, Iasi
Institutul Regional De Oncologie Iasi
Oncologie Medicala, Strada Sararie 177b, 700451, Iasi
Mnt Healthcare Europe S.R.L.
Hematologie si Oncologie Medicala, Bulevardul Ficusului 40, 013975, Bucharest
Oncomed S.R.L.
Oncologie, Strada Porumbescu Ciprian 57-59, 300239, Timisoara
Centrul De Oncologie SF Nectarie S.R.L.
Oncologie, Strada Caracal Nr 109, 200542, Craiova
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Oncologie Medicala, Strada Republicii 34-36, 400015, Cluj-Napoca
Memorial Healthcare International S.R.L.
Oncologie Medicala, Soseaua Ionescu-Sisesti Gheorghe Nr 8a, 013823, Bucharest
Centrul Medical Unirea S.R.L.
Oncologie, Strada Maniu Iuliu Nr 49, 500091, Brasov
Hospital Universitario Ramon Y Cajal
Oncología Médica, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital General Universitario Gregorio Maranon
Oncologia Medica, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Clinico Universitario De Valencia
Oncologia Medica, Avenida Blasco Ibanez 17, 46010, Valencia
University Hospital Virgen Del Rocio S.L.
Oncologia Medica, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario 12 De Octubre
Oncologia Medica, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitari Vall D Hebron
Institute of Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Clinica Universidad De Navarra
Oncologia Medica, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital De La Santa Creu I Sant Pau
Oncologia Medica, Carrer De San Quinti 89, 08041, Barcelona
Clinica Universidad De Navarra
Oncologia Medica, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Universitario Regional De Malaga
Oncología Médica, Avenida De Carlos De Haya S/N, 29010, Malaga
Hospital Del Mar
Oncología Médica, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Oncología Médica, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario De Badajoz
Oncología Médica, Avenida Elvas S/n, 06006, Badajoz
Hospital Universitari Dexeus Grupo Quironsalud
Oncología Médica, Calle De Sabino Arana 5-19, 08028, Barcelona
Instituto Multidisciplinar De Oncologia S.A.
Oncología médica, Calle De Joaquin Costa 28, 28002, Madrid
Uppsala University Hospital
Department of Hematology, Oncology and Endocrine tumors, Akademiska Sjukhuset, 751 85, Uppsala
Soedersjukhuset AB
Oncology Department, Sjukhusbacken 10, Hogalid, Stockholm
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Oncology Department, Bla Straket 5, Goteborgs Annedal, Goteborg
Karolinska University Hospital
Tema Cancer, Department of Oncology, Eugeniavagen 3, 171 64, Solna
Region Skane Skanes Universitetssjukhus
Department of Oncology, Entregatan 7, 222 42, Lund
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 |
|---|---|---|---|---|---|
| Belgium | 2025-04-02 | 2025-04-02 | |||
| France | 2025-02-10 | 2026-04-02 | |||
| Germany | 2025-04-08 | 2025-04-08 | |||
| Italy | 2025-02-26 | 2025-02-26 | |||
| Netherlands | 2025-04-22 | 2025-04-22 | |||
| Poland | 2025-03-20 | 2025-03-20 | |||
| Romania | 2025-03-06 | 2025-03-06 | |||
| Spain | 2025-02-04 | 2025-02-04 | |||
| Sweden | 2025-04-16 | 2025-04-16 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 102 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | PLACEHOLDER_D4_PF AE Text_multilingual_2024-513853-66 | 1 |
| Protocol (for publication) | PLACEHOLDER_D4_PF EORTC Q168 Interview_multilingual_2024-513853-66 | 1 |
| Protocol (for publication) | PLACEHOLDER_D4_PF EORTC Q168_multilingual_2024-513853-66 | 1 |
| Protocol (for publication) | PLACEHOLDER_D4_PF EORTC QLQ-C30_multilingual_2024-513853-66 | 3 |
| Protocol (for publication) | PLACEHOLDER_D4_PF EORTC QLQ-CR29_multilingual_2024-513853-66 | 1 |
| Protocol (for publication) | PLACEHOLDER_D4_PF EQ-5D-5L Interview_multilingual_2024-513853-66 | 1 |
| Protocol (for publication) | PLACEHOLDER_D4_PF EQ-5D-5L_multilingual_2024-513853-66 | 1 |
| Protocol (for publication) | PLACEHOLDER_D4_PF QLQ-C30 Interview_multilingual_2024-513853-66 | 1 |
| Protocol (for publication) | PLACEHOLDER_D4_PF QLQ-CR29 Interview_multilingual_2024-513853-66 | 1 |
| Protocol (for publication) | REDACTED_D1_Protocol Appendix_2024-513853-66 | Initial |
| Protocol (for publication) | REDACTED_D1_Protocol_2024-513853-66 | Am1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements _RO_ENG_2024-513853-66 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements _SE_swe_2024-513853-66 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_BE_Eng_2024-513853-66 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_DE_ENG_2024-513853-66 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_ES_ENG_2024-513853-66 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_FR_FRE_2024-513853-66 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_IT_ENG_2024-513853-66 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_NL_Eng_2024-513853-66 | 3 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_PL_pol_2024-513853-66 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material Common Study Question_BE_Dut_2024-513853-66 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material Common Study Question_BE_Fre_2024-513853-66 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material Common study questions_DE_GER_2024-513853-66 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Common Study Questions_ES_SPA_2024-513853-66 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Common study questions_HU_HUN_2024-513853-66 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Common Study Questions_RO_RUM_2024-513853-66 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Common Study Questions_SE_swe_2024-513853-66 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material CSQ_IT_ITA_2024-513853-66 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material QandA_PL_pol_2024-513853-66 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_Common Study Question_NL_Dut_2024-513853-66 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_Common Study Questions_FR_FRE_2024-513853-66 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_Referral Letter_FR_FRE_2024-513853-66 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum Study Treatment Beyond PD_IT_ITA_2024-513853-66 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum Treatment Beyond PD_PL_pol_2024-513853-66 | 5 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum_BE_Dut_2024-513853-66 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum_BE_Fre_2024-513853-66 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum_NL_Dut_2024-513853-66 | 6 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF addendum_SE_swe_2024-513853-66 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_RO_RUM_2024-513853-66 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Country Clinical_IT_ITA_2024-513853-66 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Genetic_HU_HUN_2024-513853-66 | 5 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main Clinical_HU_HUN_2024-513853-66 | 5 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_BE_Dut_2024-513853-66 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_BE_Fre_2024-513853-66 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_BE_Pol_2024-513853-66 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_NL_Dut_2024-513853-66 | 6 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Master _SE_swe_2024-513853-66 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Master_ES_SPA_2024-513853-66 | 6 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Master_PL_pol_2024-513853-66 | 6 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Patient Travel Reimbursement_IT_ITA_2024-513853-66 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnancy_IT_ITA_2024-513853-66 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnancy_PL_pol_2024-513853-66 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnancy_RO_RUM_2024-513853-66 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_BE_Dut_2024-513853-66 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_BE_Fre_2024-513853-66 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_ES_SPA_2024-513853-66 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_HU_HUN_2024-513853-66 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_SE_swe_2024-513853-66 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy Appendix Child Exposed to IMP_IT_ITA_2024-513853-66 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy Appendix Country Clinical_IT_ITA_2024-513853-66 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy Appendix Pregnant Partner_IT_ITA_2024-513853-66 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy Parents Appendix_IT_ita_2024-513853-66 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Study Treatment Beyond PD ICF Addendum_HU_HUN_2024-513853-66 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Treatment Beyond PD Addendum_ES_SPA_2024-513853-66 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Treatment Beyond PD ICF Addendum_RO_RUM_2024-513853-66 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_ES_SPA_2024-513853-66 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_HU_HUN_2024-513853-66 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_IT_ITA_2024-513853-66 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_PL_pol_2024-513853-66 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_RO_RUM_2024-513853-66 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Addendum NSMv2_Study treatment beyond PD_FR_FRE_2024-513853-66 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Addendum_Study treatment beyond PD_FR_FRE_2024-513853-66 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Clinical Informed Consent_DE_GER_2024-513853-66 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Main_FR_FRE_2024-513853-66 | 5 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Partner of pregnant participant_FR_FRE_2024-513853-66 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Pregnant Partner ICF_DE_GER_2024-513853-66 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Pregnant partner_FR_FRE_2024-513853-66 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Pregnant Partner_NL_Dut_2024-513853-66 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Treatment beyond progression ICF_DE_GER_2024-513853-66 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Withdrawal_FR_FRE_2024-513853-66 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS_Country-Specific_ICF_withdrawal_DE_GER_2024-513853-66 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_DE_GER_2024-513853-66 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_ES_SPA_2024-513853-66 | 7 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_FR_FRE_2024-513853-66 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_HU_HUN_2024-513853-66 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_IT_ITA_2024-513853-66 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_PL_pol_2024-513853-66 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_RO_RUM_2024-513853-66 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_SE_Swe_2024-513853-66 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | PLACEHOLDER_E2_SmPC Bevacizumab | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | PLACEHOLDER_E2_SmPC Cetuximab | 1 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol synopsis_BE_Dut_2024-513853-66 | Am1 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol synopsis_BE_Fre_2024-513853-66 | Am1 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol synopsis_BE_Ger_2024-513853-66 | Am1 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_ES_SPA_2024-513853-66 | Am1 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_FR_FRE_2024-513853-66 | Am1 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_HU_HUN_2024-513853-66 | Am1 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_IT_ITA_2024-513853-66 | Am1 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol synopsis_NL_Dut_2024-513853-66 | Am1 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_PL_pol_2024-513853-66 | Am1 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_RO_RUM_2024-513853-66 | Am1 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_SE_swe_2024-513853-66 | Am1 |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-05 | Spain | Acceptable 2025-01-15
|
2025-01-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-01-23 | Acceptable | 2025-02-17 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-23 | Acceptable | 2025-02-05 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-01-23 | Acceptable | 2025-02-21 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-01-23 | Acceptable | 2025-03-10 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-03-24 | Acceptable | 2025-03-28 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-08-27 | Spain | Acceptable 2025-11-21
|
2025-11-21 |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-12-10 | Acceptable | 2025-12-17 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-12-12 | Acceptable | 2026-01-07 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-9 | 2026-02-18 | Spain | Acceptable | 2026-03-18 |
| 11 | SUBSTANTIAL MODIFICATION | SM-10 | 2026-02-26 | Acceptable | 2026-04-20 |