Overview
Sponsor-declared trial summary
Phase
Phase II and Phase III (Integrated)
Status
Ongoing, recruiting
Participants planned
990
Countries
11
Sites
68
Untreated, Unresectable or Metastatic Colorectal Cancer
Phase 2: The main objective will be to compare the tumor response to the drug of participants on study drug vs standard of care. Phase 3: The main objective is to compare the tumor growth of participants on study drug vs standard of care.
Key facts
- Sponsor
- Bristol-Myers Squibb Services Unlimited Company
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 30 Mar 2026 → ongoing
- Decision date (initial)
- 2026-03-13
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Bristol-Myers Squibb Services Unlimited Company
External identifiers
- EU CT number
- 2025-523224-45-00
- WHO UTN
- U1111-1325-6505
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic, Safety, Efficacy, Dose response, Pharmacokinetic
Phase 2: The main objective will be to compare the tumor response to the drug of participants on study drug vs standard of care.
Phase 3: The main objective is to compare the tumor growth of participants on study drug vs standard of care.
Secondary objectives 2
- Phase 2: To determine a dose for the Phase 3 part of the trial.
- Phase 3: To evaluate if the response to study drug is long-lasting, and if patients live longer on the study drug compared to standard of care.
Conditions and MedDRA coding
Untreated, Unresectable or Metastatic Colorectal Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | LLT | 10052362 | Metastatic colorectal cancer | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Participants must be at least 18 years of age.
- Have colorectal cancer that has come back or spread and cannot be cured with surgery.
- Have not had cancer treatment before.
- Do not have a type of colorectal cancer known as dMMR/MSI-H.
- Do not have a BRAF V600E gene mutation.
- Have cancer that can be measured on a scan.
Exclusion criteria 4
- Have cancer that has spread to the brain, spinal cord, or surrounding areas and has not been treated.
- Had other active cancer in the past 2 years (except low-risk cases that have been cured locally).
- Have serious heart problems, such as a recent heart attack, stroke, blocked arteries, uncontrolled high blood pressure, or certain genetic heart rhythm issues.
- Have already had checkpoint inhibitors, CD137 agonists, or chemotherapy.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Phase 2: To compare what proportion of participants in the study drug and standard of care arm respond to treatment (OR).
- Phase 3: Primary endpoints will be defined as the time from when the participant is randomized to when the disease worsens or death from any cause (PFS).
Secondary endpoints 2
- Phase 2: To assess all available data including how effective, safe and tolerable the study drug is to arrive at a dose.
- Phase 3: To evaluate how long patients live (OS) and how long the study drug effects on the tumor growth last after it is given (DOR).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 8
SUB12474MIG · Substance
- Active substance
- Capecitabine
- Pharmaceutical form
- FILM COATED TABLETS
- Route of administration
- ORAL USE
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The product will be removed from the carton, over-labeled, and repackaged.
SUB12474MIG · Substance
- Active substance
- Capecitabine
- Pharmaceutical form
- FILM COATED TABLETS
- Route of administration
- ORAL USE
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The product will be removed from the carton, over-labeled, and repackaged.
PRD13426964 · Product
- Active substance
- Pumitamig
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 9999 mg/ml milligram(s)/millilitre
- Max total dose
- 9999 mg/ml milligram(s)/millilitre
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BIONTECH SE
- Paediatric formulation
- No
- Orphan designation
- No
PRD13426963 · Product
- Active substance
- Pumitamig
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 9999 mg/ml milligram(s)/millilitre
- Max total dose
- 9999 mg/ml milligram(s)/millilitre
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BIONTECH SE
- Paediatric formulation
- No
- Orphan designation
- No
SUB09490MIG · Substance
- Active substance
- Oxaliplatin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 9999 mg/ml milligram(s)/millilitre
- Max total dose
- 9999 mg/ml milligram(s)/millilitre
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The product will be removed from the carton, over-labeled, and repackaged.
SUB06052MIG · Substance
- Active substance
- Calcium Folinate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 9999 mg/ml milligram(s)/millilitre
- Max total dose
- 9999 mg/ml milligram(s)/millilitre
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The product will be removed from the carton, over-labeled, and repackaged.
Irinotecan Hydrochloride Trihydrate
SUB45873 · Substance
- Active substance
- Irinotecan Hydrochloride Trihydrate
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 9999 mg/ml milligram(s)/millilitre
- Max total dose
- 9999 mg/ml milligram(s)/millilitre
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The product will be removed from the carton, over-labeled, and repackaged.
SUB07721MIG · Substance
- Active substance
- Fluorouracil
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 9999 mg/ml milligram(s)/millilitre
- Max total dose
- 9999 mg/ml milligram(s)/millilitre
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The product will be removed from the carton, over-labeled, and repackaged.
Comparator 1
SUB16402MIG · Substance
- Active substance
- Bevacizumab
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 9999 mg/ml milligram(s)/millilitre
- Max total dose
- 9999 mg/ml milligram(s)/millilitre
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The product will be removed from the carton, over-labeled, and repackaged.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bristol-Myers Squibb Services Unlimited Company
- Sponsor organisation
- Bristol-Myers Squibb Services Unlimited Company
- Address
- Plaza 254, Blanchardstown Corporate Park 2 Blanchardstown Corporate Park 2
- City
- Dublin 15
- Postcode
- D15 T867
- Country
- Ireland
Scientific contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GSM-CT
Public contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GSM-CT
Third parties 10
| Organisation | City, country | Duties |
|---|---|---|
| Endpoint Clinical Inc. ORL-000012879
|
Wakefield, United States | Other |
| Iqvia Holdings Inc. ORG-100043905
|
Durham, United States | Other |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Other |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Other |
| Massive Bio Inc. ORG-100044618
|
New York, United States | Other, Code 2 |
| Clario ORL-000013638
|
Philadelphia, United States | Other |
| Azenta Germany GmbH ORL-000011894
|
Griesheim, Germany | Other |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Other |
| BioAgilytix Europe GmbH ORG-100016335
|
Hamburg, Germany | Other |
| Mural Health Technologies Inc. ORG-100051510
|
Berwyn, United States | Other |
Locations
11 EU/EEA countries · 68 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Authorised, recruiting | 12 | 3 |
| Belgium | Authorised, recruitment pending | 24 | 4 |
| Czechia | Authorised, recruitment pending | 18 | 4 |
| France | Ongoing, recruiting | 48 | 10 |
| Germany | Ongoing, recruiting | 55 | 12 |
| Italy | Ongoing, recruiting | 44 | 8 |
| Netherlands | Not authorised | 24 | 4 |
| Poland | Authorised, recruitment pending | 36 | 7 |
| Romania | Ongoing, recruiting | 34 | 6 |
| Spain | Ongoing, recruiting | 36 | 7 |
| Sweden | Not authorised | 15 | 3 |
| Rest of world
Brazil, Turkey, Singapore, China, Korea, Republic of, United States, Taiwan, Canada, Japan, United Kingdom, Argentina, Chile, India, Australia
|
— | 644 | — |
Investigational sites
Medical University Of Vienna
Department of Medicine I, Division of Oncology, Waehringer Guertel 18-20, Alsergrund, Vienna
Ordensklinikum Linz GmbH
Internal I, Medical Oncology and Hematology, Seilerstaette 4, 4010, Linz
SCRI CCCIT Ges.m.b.H.
III Medical Departm. with Hematology, Medic. Oncology, Hemostaseology, Infect. Disease, Rheumatology, Muellner Hauptstrasse 48, 5020, Salzburg
Algemeen Ziekenhuis Delta
Gastroenterology, Deltalaan 1, 8800, Roeselare
Cliniques Universitaires Saint-Luc
Medical Oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
University Of Antwerp
Oncology, Drie Eikenstraat 663, 2650, Edegem
UZ Leuven
Gastroenterology, Herestraat 49, 3000, Leuven
Masarykuv Onkologicky Ustav
Klinika komplexni onkologicke pece, Zluty Kopec 543/7, Stare Brno, Brno-Stred
Fakultni Nemocnice V Motole
Onkologická klinika 2. LF UK a FN Motol, V Uvalu 84/1, Motol, Prague
Fakultni Nemocnice Hradec Kralove
Klinika onkologie a radioterapie, Sokolska 581, Novy Hradec Kralove, Hradec Kralove
Vseobecna Fakultni Nemocnice V Praze
Onkologicka klinika, U Nemocnice 499/2, Nove Mesto, Prague
Institut Gustave Roussy
Medicine, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut De Cancerologie De L Ouest
Medical Oncology, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Centre Hospitalier Universitaire Rouen
HepatoGastroenterology, 1 Rue De Germont, 76000, Rouen
Assistance Publique Hopitaux De Paris
Medical Oncology, 184 Rue Du Faubourg Saint Antoine, 75012, Paris
Centre Hospitalier Regional De Marseille
HepatoGastroenterology, 264 Rue Saint Pierre, 13005, Marseille
Centre Hospitalier Universitaire De Toulouse
Digestive Medical Oncology, 1 Place Du Docteur Joseph Baylac, 31300, Toulouse
Institut Paoli Calmettes
Medical Oncology, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Centre Hospitalier Universitaire De Nantes
HepatoGastroenterology, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire De Dijon
HepatoGastroenterology, 14 Rue Paul Gaffarel, 21000, Dijon
Centre Hospitalier Universitaire De Bordeaux
Digestive oncology, Avenue De Magellan, 33600, Pessac
Krankenhaus Nordwest GmbH
Institut für Klinische Krebsforschung IKF, Steinbacher Hohl 2-26, Praunheim, Frankfurt Am Main
Technische Universitaet Dresden
Med Klinik und Poliklinik I, Bereich Klinische Studien, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Marien Hospital Duesseldorf GmbH
Klinik für Onkologie, Hämatologie und Palliativmedizin, Rochusstrasse 2, Pempelfort, Duesseldorf
Muenchen Klinik gGmbH
Klinik für Onkologie und Hämatologie, Oskar-Maria-Graf-Ring 51, Ramersdorf-Perlach, Munich
Heidelberg University
Mannheim Cancer Center, Universität Heidelberg, Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
I. Medizinische Klinik und Poliklinik, Langenbeckstrasse 1, Oberstadt, Mainz
Haematologisch Onkologische Praxis Eppendorf
Norddeutsches Studienzentrum für Innovative Onkologie (NIO), Eppendorfer Landstrasse 42, Orchideenstieg 12, Hamburg
Katholisches Klinikum Bochum gGmbH
Hämatologie, Onkologie und Palliativmedizin, Gudrunstrasse 56, Grumme, Bochum
Universitaetsklinikum Ulm AöR
Klinik für Innere Medizin I, Albert-Einstein-Allee 23, Eselsberg, Ulm
Charite Universitaetsmedizin Berlin KöR
Hämatologie, Onkologie und Krebs Immunologie (CCM), Chariteplatz 1, Mitte, Berlin
Universitaetsmedizin Goettingen
Klinik für Gastroenterologie und gastrointestinale Onkologie, Robert-Koch-Strasse 40, Weende, Goettingen
Universitaet Leipzig
Universitäres Krebszentrum Leipzig (UCCL), Liebigstrasse 22, Zentrum-Suedost, Leipzig
Azienda Ospedaliero Universitaria Pisana
UO Oncologia Medica 2 Universitaria,, Via Roma 67, 56126, Pisa
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Abdominal Oncology, Via Mariano Semmola 52, 80131, Naples
Presidio Ospedaliero Garibaldi-Nesima
U.O.C. Oncologia Medica, Via Palermo, 636, Catania
IRCCS - Ospedale San Raffaele
Medical Oncology, Via Olgettina 60, 20132, Milano
ASST Grande Ospedale Metropolitano Niguarda
Medical Oncology, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Istituto Oncologico Veneto
UOC Oncology 1,, Via Gattamelata 64, 35128, Padova
Azienda USL IRCCS Di Reggio Emilia
Onclologia Medica, Viale Risorgimento 80, 42123, Reggio Emilia
Casa Sollievo Della Sofferenza
U.O.C. di Oncologia, Viale Convento Cappuccini 1, 71013, San Giovanni Rotondo
Stichting Elisabeth-TweeSteden Ziekenhuis
Medical oncology, Hilvarenbeekseweg 60, 5022 GC, Tilburg
Amsterdam UMC Stichting
Medical oncology, De Boelelaan 1117, 1081 HV, Amsterdam
Universitair Medisch Centrum Groningen
Medical oncology, Hanzeplein 1, 9713 GZ, Groningen
St. Antonius Ziekenhuis
Medical oncology, Soestwetering 1, 3543 AZ, Utrecht
Lux Med Onkologia Sp. z o.o.
Oddział Onkologii Klinicznej/Chemioterapii, Ul. Szamocka 6, 01-748, Warsaw
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
N/A, Ul. Wybrzeze Armii Krajowej 15, 44-102, Gliwice
Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Klinika Onkologii z Odcinkiem Dziennym, Ul. Katowicka 66a, 45-061, Opole
Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej
Oddział Onkologii Klinicznej i Chemioterapii, Ul. Michala Kleofasa Oginskiego 6, 58-506, Jelenia Gora
Mazowiecki Szpital Onkologiczny Sp. z o.o.
Poradnia Onkologiczna, Ul. Koscielna 61, 05-135, Wieliszew
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Oddział Onkologii, Ul. Woloska 137, 02-507, Warsaw
Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.
Oddział Onkologii Klinicznej z Pododziałem Dziennym, Os. Zlotej Jesieni 1, 31-826, Cracow
Centrul De Oncologie SF Nectarie S.R.L.
Oncology, Strada Caracal Nr 109, 200542, Craiova
Institutul Clinic Fundeni
Oncology, Soseaua Fundeni 258, 022328, Bucharest
Institutul Regional De Oncologie Iasi
Oncology, Strada G-Ral Berthelot 2-4, 700483, Iasi
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Oncology, Strada Republicii 34-36, 400015, Cluj-Napoca
Institutul Regional De Gastroenterologie Hepatologie Prof. Dr. Octavian Fodor Cluj
Oncology, Strada Croitorilor 19-21, 400162, Cluj-Napoca
Centrul De Oncologie-Euroclinic S.R.L.
Oncology, Strada Conta Vasile 2, 700106, Iasi
Hospital Universitario 12 De Octubre
Oncology, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital General Universitario Gregorio Maranon
Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitario De Navarra
Oncology, Irunlarrea Kalea 3, 31008, Pamplona
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario Regional De Malaga
Oncology, Avenida De Carlos De Haya S/N, 29010, Malaga
Hospital Germans Trias I Pujol
Oncology, Carretera Canyet 1a Planta, 08916, Badalona
Karolinska University Hospital
Medicinsk enhet Övre Buk, GI onkologi, Eugeniavagen 3, 171 64, Solna
Region Skane Skanes Universitetssjukhus
VO Hematologi, Onkologi och Strålningsfysik, Lasarettsgatan 23A, 221 85 Lund, Entregatan 7, 222 42, Lund
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Ongologiska kliniken, Bla Straket 5, Goteborgs Annedal, Goteborg
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 | 2026-04-15 | ||||
| France | 2026-03-30 | 2026-04-16 | |||
| Germany | 2026-03-30 | 2026-04-08 | |||
| Italy | 2026-04-07 | 2026-04-08 | |||
| Romania | 2026-03-31 | 2026-04-02 | |||
| Spain | 2026-03-30 | 2026-03-31 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 113 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2025-523224-45 redacted | 01 EU |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_BE_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_NL_Recruitment arrangements | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment and IC Procedure_AT | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and IC procedure_FR | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_CZ | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_DE | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_ES | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_IT | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_PL | 1.1 |
| Recruitment arrangements (for publication) | K2_Dr to Patient Letter_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Brochure_AT | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Brochure_DE | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Brochure_PL | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Dose Modification | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Optional Future Research_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Optional Sample Collection_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnant Partner | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Mural Health DPN | 1 |
| Subject information and informed consent form (for publication) | L1_NL_SIS and ICF Dose Switch | 1.1 |
| Subject information and informed consent form (for publication) | L1_NL_SIS and ICF Future Research Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_NL_SIS and ICF Main Redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_NL_SIS and ICF Optional Sample Collection Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_NL_SIS and ICF Participant who Becomes Pregnant | 1.2 |
| Subject information and informed consent form (for publication) | L1_NL_SIS and ICF Pregnant Partner | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Dosage Switch_PL | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Dose switch_IT | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_IT_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Phase 2_FR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Phase 3_FR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_PL_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research_IT_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research_PL_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Sample Collection_IT_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Sample Collection_PL_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional_Future Research_FR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional_Samples Collection_FR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Participant Who Becomes Pregnant_PL_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant_IT_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_ IT_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant partner_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_PL_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Privacy notice_IT_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Reimbursement_IT_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BEL_Main_DUT_TC_For Publication | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BEL_Main_ENG_TC_For Publication | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BEL_Main_FRE_TC_For Publication | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Dose Switch_AT | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Dose Switch_CZ | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Dose Switch_DE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Dose switch_DUT_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Dose switch_ENG_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Dose Switch_ES | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Dose Switch_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Dose switch_FRE_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future Research_AT_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future Research_DE_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_AT_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_CZ_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_DE_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_DUT_For Publication | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_DUT_TC_For Publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_ENG_For Publication | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_ENG_TC_For Publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_ES_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_FRE_For Publication | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_FRE_TC_For Publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Future Research_CZ_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional future research_ES_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Sample Collection_CZ_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Sample_AT_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Sample_DE_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Sample_DUT_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Sample_ENG_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Sample_FRE_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional samples collection_ES_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant_AT | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_AT | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_CZ | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_DE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_DUT_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_ENG_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant partner_ES | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_FRE_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Study Participant Alert Card_FR | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS ICF Dose Switch | 1 |
| Subject information and informed consent form (for publication) | L1_SIS ICF Future Research_Clean_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS ICF Main_Clean_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS ICF Optional Sample Collection_Clean_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS ICF Pregnant Partner_Clean | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Persona Data_CZ_Redacted | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Bevacizumab | 65 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Calcium folinate | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Capecitabine | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Fluorouracil | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Irinotecan Hydrochloride Trihydrate | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Oxaliplatin | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-523224-45_CZ | 02 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-523224-45_DE | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-523224-45_DUT-BE | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-523224-45_EN | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-523224-45_ES | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-523224-45_FR | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-523224-45_FRE-BE | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-523224-45_GER-BE | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-523224-45_IT | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-523224-45_NL | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-523224-45_PL | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EU CT 2025-523224-45_SE | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EU-CT 2025-523224-45_RO | 2 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-31 | Spain | Acceptable with conditions 2026-03-09
|
2026-03-10 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-17 | Acceptable with conditions 2026-03-09
|
2026-03-17 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-03-17 | Acceptable with conditions 2026-03-09
|
2026-03-17 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-03-17 | Acceptable with conditions 2026-03-09
|
2026-03-17 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-03-17 | Acceptable with conditions 2026-03-09
|
2026-03-17 | |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2026-03-17 | Spain | Acceptable with conditions 2026-03-09
|
2026-03-17 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2026-03-17 | Acceptable with conditions 2026-03-09
|
2026-03-17 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-03-17 | Acceptable with conditions | 2026-03-25 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-03-17 | Acceptable with conditions | 2026-04-02 |