Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
518
Countries
9
Sites
51
KRAS G12C-mutant, Locally Advanced Unresectable or Metastatic Colorectal Cancer
1. To evaluate the safety and tolerability of treatment with MK-1084, cetuximab, and mFOLFOX6 2. To compare MK-1084, cetuximab, and mFOLFOX6 versus mFOLFOX6 with or without bevacizumab with respect to PFS per RECIST 1.1 as assessed by blinded independent central review (BICR)
Key facts
- Sponsor
- Merck Sharp & Dohme LLC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 26 Sep 2025 → ongoing
- Decision date (initial)
- 2025-09-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Merck Sharp & Dohme LLC
External identifiers
- EU CT number
- 2024-517232-22-00
- WHO UTN
- U1111-1311-8311
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacogenomic, Others, Pharmacogenetic, Safety, Pharmacokinetic, Pharmacodynamic, Efficacy, Therapy
1. To evaluate the safety and tolerability of treatment with MK-1084, cetuximab, and mFOLFOX6
2. To compare MK-1084, cetuximab, and mFOLFOX6 versus mFOLFOX6 with or without bevacizumab with respect to PFS per RECIST 1.1 as assessed by blinded independent central review (BICR)
Secondary objectives 6
- To compare MK-1084, cetuximab, and mFOLFOX6 versus mFOLFOX6 with or without bevacizumab with respect to ORR per RECIST 1.1 by BICR
- To compare MK-1084, cetuximab, and mFOLFOX6 versus mFOLFOX6 with or without bevacizumab with respect to OS
- To evaluate MK-1084, cetuximab, and mFOLFOX6 versus mFOLFOX6 with or without bevacizumab with respect to DOR per RECIST 1.1 by BICR
- To evaluate the safety and tolerability of MK-1084 in combination with cetuximab and mFOLFOX6
- To evaluate MK-1084 with mFOLFOX6 plus cetuximab versus mFOLFOX6 with or without bevacizumab with respect to the mean change from baseline in global health status/QoL, physical functioning, role functioning, appetite loss, and bloating
- To evaluate MK-1084, cetuximab, and mFOLFOX6 versus mFOLFOX6 with or without bevacizumab with respect to time to deterioration in global health status/QoL, physical functioning, role functioning, appetite loss, and bloating
Conditions and MedDRA coding
KRAS G12C-mutant, Locally Advanced Unresectable or Metastatic Colorectal Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 25.1 | LLT | 10069759 | KRAS mutation | 10018065 |
| 27.0 | LLT | 10052362 | Metastatic colorectal cancer | 10029104 |
Regulatory references
- Scientific advice from competent authorities
- Food And Drug Administration
- Plan to share IPD
- Yes
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Has a histologically confirmed diagnosis of locally advanced unresectable or metastatic (unresectable Stage III or Stage IV as defined by American Joint Committee on Cancer [AJCC] eighth edition) colorectal adenocarcinoma
- Part 2 only: Has not received systemic anticancer therapy for locally advanced unresectable or metastatic colorectal cancer
- Tumor tissue demonstrates presence of a Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
- Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
Exclusion criteria 12
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn’s disease, ulcerative colitis, chronic diarrhea)
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
- Has known dihydropyrimidine dehydrogenase (DPD) deficiency
- HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease
- Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization
- Has 1 or more conditions that, in the opinion of the investigator, make the participant ineligible for treatment with bevacizumab
- Has known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis or leptomeningeal disease
- Has active infection requiring systemic therapy
- Has history of stem cell/solid organ transplant
- Has not adequately recovered from major surgery or have ongoing surgical complications.
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 4
- Number of Participants Experiencing Dose-Limiting Toxicity (DLT)
- Part 1: Number of Participants Who Experience an Adverse Event (AE)
- Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE
- Progression-free Survival (PFS)
Secondary endpoints 15
- Objective Response Rate (ORR)
- Overall Survival (OS)
- Duration of Response (DOR)
- Part 2: Number of Participants Who Experience an AE
- Part 2: Number of Participants Who Discontinue Study Treatment Due to an AE
- Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score
- Change from Baseline in the EORTC-QLQ-C30 Physical Functioning (Items 1-5) Score
- Change from Baseline in the EORTC-QLQ-C30 Role Functioning (Items 6 and 7) Score
- Change from Baseline in the EORTC-QLQ-C30 Appetite Loss (Item 13) Score
- Change from Baseline in the EORTC-Quality of Life Questionnaire-Colorectal Cancer-Specific 29 Items (QLQ-CR29) Bloating (Item 37) Score
- Time to First Deterioration (TTD) in EORTC QLQ-C30 Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score
- TTD in EORTC QLQ-C30 Physical Functioning (Items 1-5) Score
- TTD in EORTC QLQ-C30 Role Functioning (Items 6 and 7) Score
- TTD in EORTC QLQ-C30 Appetite Loss (Item 13) Score
- TTD in EORTC QLQ-CR29 Bloating (Item 37) Score
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 9
SCP128961 · ATC
- Active substance
- Oxaliplatin
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 85 mg/m2 milligram(s)/square meter
- Max total dose
- 13260 mg/m2 milligram(s)/square meter
- Max treatment duration
- 72 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XA03 — OXALIPLATIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1165178 · ATC
- Active substance
- Fluorouracil
- Substance synonyms
- 5-FLOUROURACIL, 5-FLUORO-1H-PYRIMIDINE-2,4-DIONE, 5-FLUOROURACIL, 5-FU
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 1200 mg/m2 milligram(s)/square meter
- Max total dose
- 436800 mg/m2 milligram(s)/square meter
- Max treatment duration
- 72 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BC02 — FLUOROURACIL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD12769269 · Product
- Active substance
- MK-1084
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 0 % (V/V) percent volume/volume
- Max total dose
- 0 % (V/V) percent volume/volume
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD9352351 · Product
- Active substance
- MK-1084
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 0 % (V/V) percent volume/volume
- Max total dose
- 0 % (V/V) percent volume/volume
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD9352352 · Product
- Active substance
- MK-1084
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 0 % (V/V) percent volume/volume
- Max total dose
- 0 % (V/V) percent volume/volume
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD12765020 · Product
- Active substance
- MK-1084
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 0 % (V/V) percent volume/volume
- Max total dose
- 0 % (V/V) percent volume/volume
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
SCP107133400 · ATC
- Active substance
- Calcium Folinate
- Substance synonyms
- LEUCOVORIN CALCIUM
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 400 mg/m2 milligram(s)/square meter
- Max total dose
- 62400 mg/m2 milligram(s)/square meter
- Max treatment duration
- 72 Month(s)
- Authorisation status
- Authorised
- ATC code
- V03AF03 — CALCIUM FOLINATE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP124186993 · ATC
- Active substance
- Calcium Folinate
- Substance synonyms
- LEUCOVORIN CALCIUM
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 200 mg/m2 milligram(s)/square meter
- Max total dose
- 31200 mg/m2 milligram(s)/square meter
- Max treatment duration
- 72 Month(s)
- Authorisation status
- Authorised
- ATC code
- V03AF04 — CALCIUM LEVOFOLINATE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP185672 · ATC
- Active substance
- Cetuximab
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 500 mg/m2 milligram(s)/square meter
- Max total dose
- 78000 mg/m2 milligram(s)/square meter
- Max treatment duration
- 72 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FE01 — CETUXIMAB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 4
Avastin 25 mg/ml concentrate for solution for infusion.
PRD389577 · Product
- Active substance
- Bevacizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 5 mg/kg milligram(s)/kilogram
- Max total dose
- 780 mg/kg milligram(s)/kilogram
- Max treatment duration
- 72 Month(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
Avastin 25 mg/ml concentrate for solution for infusion.
PRD389578 · Product
- Active substance
- Bevacizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 5 mg/kg milligram(s)/kilogram
- Max total dose
- 780 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 72 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FG01 — -
- Marketing authorisation
- EU/1/04/300/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
MVASI 25 mg/mL concentrate for solution for infusion
PRD6036173 · Product
- Active substance
- Bevacizumab
- Substance synonyms
- BI 695502, BS-503A, PF-06439535, BP01, HLX04, RHUMAB-VEGF, BEVACIZUMABUM, RHUMAB VEGF
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 5 mg/kg milligram(s)/kilogram
- Max total dose
- 780 mg/kg milligram(s)/kilogram
- Max treatment duration
- 72 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XC07 — -
- Marketing authorisation
- EU/1/17/1246/001
- MA holder
- AMGEN TECHNOLOGY (IRELAND) UC
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
MVASI 25 mg/mL concentrate for solution for infusion
PRD6036172 · Product
- Active substance
- Bevacizumab
- Substance synonyms
- BI 695502, BS-503A, PF-06439535, BP01, HLX04, RHUMAB-VEGF, BEVACIZUMABUM, RHUMAB VEGF
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 5 mg/kg milligram(s)/kilogram
- Max total dose
- 780 mg/kg milligram(s)/kilogram
- Max treatment duration
- 72 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XC07 — -
- Marketing authorisation
- EU/1/17/1246/002
- MA holder
- AMGEN TECHNOLOGY (IRELAND) UC
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Merck Sharp & Dohme LLC
- Sponsor organisation
- Merck Sharp & Dohme LLC
- Address
- 126 East Lincoln Avenue, P. O. Box 2000 P. O. Box 2000
- City
- Rahway
- Postcode
- 07065-4607
- Country
- United States
Scientific contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- David Fogelman
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- David Fogelman
Third parties 7
| Organisation | City, country | Duties |
|---|---|---|
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Interactive response technologies (IRT) |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Laboratory analysis |
| Hematogenix Laboratory Services LLC ORG-100040020
|
Tinley Park, United States | Laboratory analysis |
| Perceptive Informatics Inc. ORG-100013171
|
Burlington, United States | Other |
| Parexel International Corp. ORG-100007310
|
Auburndale, United States | Other |
| Syneos Health Clinique Inc. ORG-100028348
|
Quebec, Canada | Laboratory analysis |
| Signant Health Management Limited ORG-100040504
|
Reading, United Kingdom | E-data capture |
Locations
9 EU/EEA countries · 51 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Authorised, recruiting | 6 | 2 |
| France | Ongoing, recruiting | 30 | 11 |
| Germany | Ongoing, recruiting | 10 | 5 |
| Hungary | Authorised, recruiting | 6 | 2 |
| Italy | Ongoing, recruiting | 20 | 7 |
| Netherlands | Authorised, recruiting | 8 | 4 |
| Poland | Ongoing, recruiting | 25 | 5 |
| Romania | Ongoing, recruiting | 15 | 6 |
| Spain | Ongoing, recruiting | 21 | 9 |
| Rest of world
Mexico, Turkey, Australia, United States, Singapore, United Kingdom, Argentina, Malaysia, Hong Kong, Ukraine, Colombia, Korea, Republic of, Chile, Israel, China, Brazil, Philippines, Japan, Taiwan, Canada
|
— | 377 | — |
Investigational sites
HUS-Yhtymae
HUS, Comprehensive Cancer Center, Haartmaninkatu 4, 00290, Helsinki
Tampere University Hospital
FONK, Elamanaukio 2, 33520, Tampere
Institut Godinot
Oncologie, 1 Rue Du General Koenig, 51100, Reims
Assistance Publique Hopitaux De Paris
Oncologie Digestive, 20 Rue Leblanc, 75015, Paris
Centre Hospitalier Universitaire De Nice
Hépato Gastro-Entérologe et Oncologie Digestive, 151 Route De Saint Antoine, 06200, Nice
Institut Sainte Catherine
Oncologie- Radiothérapie, 250 Chemin De Baigne Pieds, 84000, Avignon
CHRU De Nancy
Gastro-entérologie, 11 Rue Du Morvan, Bp 80001, Vandoeuvre Les Nancy Cedex
Centre Francois Baclesse
Pathologie Digestive, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Centre Hospitalier Universitaire De Toulouse
Oncologie Médicale Digestive, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Centre Hospitalier Universitaire Rouen
Hepato-gastroenterologie, 1 Rue De Germont, 76000, Rouen
Centre Hospitalier Et Universitaire De Limoges
Oncologie, 2 Avenue Martin Luther King, 87000, Limoges
Assistance Publique Hopitaux De Paris
Oncologie, 184 Rue Du Faubourg Saint Antoine, 75012, Paris
Institut De Cancerologie De L Ouest
Oncologie, 15 Rue Andre Boquel, 49100, Angers
Katholisches Marienkrankenhaus gGmbH
Onkologisches Zentrum, Alfredstrasse 9, Hohenfelde, Hamburg
Asklepios Kliniken Hamburg GmbH
Hämatologie, internistische Onkologie und Palliativmedizin, Paul-Ehrlich-Strasse 1, Othmarschen, Hamburg
KEM I Evang. Kliniken Essen-Mitte gGmbH
Klinik für Internistische Onkologie & Hämatologie mit integrierter Palliativmedizin, Henricistrasse 92, Huttrop, Essen
Charite Universitaetsmedizin Berlin KöR
Med. Klinik m. S. Hämatologie, Onkologie und Tumorimmunologie, Chariteplatz 1, Mitte, Berlin
Goethe University Frankfurt
Medizinische Klinik I, Gastrointestinale Onkologie, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Semmelweis University
Belgyógyászati és Hematológiai Klinika, Szentkiralyi Utca 46, VIII Kerulet, Budapest VIII
University Of Pecs
Onkoterápiás Klinika, Edesanyak Utja 17, 7624, Pecs
Ospedale San Raffaele S.r.l.
Dipartimento di Oncologia Medica, Via Olgettina 60, 20132, Milan
Azienda Ospedaliero-Universitaria Di Cagliari
Oncologia Medica, Strada Statale 554 N. 1, 09042, Monserrato
Azienda Ospedaliera Universitaria Integrata Verona
Oncologia, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Azienda Unita Sanitaria Locale Della Romagna
UOC Oncologia, Viale Vincenzo Randi 5, 48121, Ravenna
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
UOC Oncoematologia, Via Sergio Pansini 5, 80131, Naples
ASST Grande Ospedale Metropolitano Niguarda
Oncologia Falck, Dipartimento di Ematologia e Oncologia, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Istituto Oncologico Veneto
UOC Oncologia 1, Via Gattamelata 64, 35128, Padova
Amsterdam UMC Stichting
Medical Oncology, De Boelelaan 1117, 1081 HV, Amsterdam
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Medical Oncology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Radboud universitair medisch centrum Stichting
Medical Oncology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Amphia Hospital
Medical Oncology, Molengracht 21, 4818 CK, Breda
Mruk-Med I Sp. z o.o.
n/a, Ul. Gen. Mariana Langiewicza 61, 35-021, Rzeszow
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Onkologii i Radioterapii, Ul. Wawelska 15, 02-034, Warsaw
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Oddział w Gliwicach Oddział Chemioterapii Dziennej, Ul. Wybrzeze Armii Krajowej 15, 44-102, Gliwice
Wielkopolskie Centrum Onkologii Im. Marii Sklodowskiej-Curie
Oddział Onkologii Klinicznej i Immunoonkologii z Pododdziałem Dziennym i Izbą Przyjęć, Ul. Garbary 15, 61-866, Poznan
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Oddział Onkologii Klinicznej z Pododdziałem Chemioterapii Jednodniowej, Ul. Tytusa Chalubinskiego 7, 75-581, Koszalin
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Oncologie Medicala, Strada Republicii 34-36, 400015, Cluj-Napoca
Institutul Clinic Fundeni
Oncologie Medicala, Soseaua Fundeni 258, 022328, Bucharest
Institutul Regional De Oncologie Iasi
Oncologie Medicala, Strada G-Ral Berthelot 2-4, 700483, Iasi
Radiotherapy Center Cluj S.R.L.
Oncologie Medicala, Str. Razoare Nr. 486g Jud. Cluj, 407280, Floresti
Centrul De Oncologie SF Nectarie S.R.L.
Oncologie Medicala, Strada Caracal Nr 109, 200542, Craiova
Institutul Regional De Oncologie Iasi
Oncologie Medicala, Strada Sararie 177b, 700451, Iasi
Hospital Clinico San Carlos
Medical Oncology, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Complejo Hospitalario Universitario Insular Materno Infantil
Medical Oncology, Autovia Del Sur S/n, 35017, Las Palmas De Gran Canaria
Fundacion Instituto Valenciano De Oncologia
Oncology, Calle Professor Beltran Baguena 8, 46009, Valencia
Hospital Universitario Central De Asturias
Medical Oncology, Avenida De Roma S/n, 33011, Oviedo
Institut Catala D'oncologia
Medical Oncology, Carretera Canyet S/n, 08916, Badalona
University Hospital Virgen Del Rocio S.L.
Medical Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital General Universitario Gregorio Maranon
Medical Oncology, Calle Del Doctor Esquerdo 46, 28007, Madrid
Hospital Universitario Marques De Valdecilla
Medical Oncology, Avenida Valdecilla Sn, 39008, Santander
Hospital Universitari Vall D Hebron
Oncología Médica, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Finland | 2025-10-02 | ||||
| France | 2025-10-23 | 2026-04-16 | |||
| Germany | 2025-10-07 | 2026-04-17 | |||
| Hungary | 2026-04-01 | ||||
| Italy | 2026-02-12 | 2026-02-24 | |||
| Netherlands | 2025-10-17 | ||||
| Poland | 2025-11-12 | 2026-05-29 | |||
| Romania | 2025-10-06 | 2026-05-04 | |||
| Spain | 2025-09-26 | 2025-09-29 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 90 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-517232-22_SM02_for pub | 02R |
| Protocol (for publication) | D4_Copyright statement eCOA Tablet_IN_for pub | 04DEC2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_DEU_EN_IN_for pub | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_ESP_ES_IN_for pub | 18MAR2025R |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_FIN_EN_IN_for pub | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_FRA_FR_SM02_for pub | 13JAN2026 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_HUN_EN_IN_for pub | 23May2025 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_ITA_EN_SM02_for pub | 05JAN2026 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_NLD_EN_IN-RFI014_for pub | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_POL_PL_SM02_for pub | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_ROU_RO_SM02_for pub | 18JAN2026 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Advocacy Card_HUN_HU_IN-RFI008_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Brochure_DEU_DE_SM02_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Master Tissue Brochure_HUN_HU_IN-RFI008_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Master Tissue Brochure_ROU_EN_SM02-RFI001_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Master Tissue Brochure_ROU_RO_SM02_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_FRA_FR_SM02_for pub | 29OCT2025 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_HUN_HU_IN-RFI008_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_ITA_IT_IN_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_NLD_NL_IN-RFI014_for pub | 1.00 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_ROU_EN_SM02-RFI001_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_ROU_RO_SM02_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Flyer_HUN_HU_IN-RFI008_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Poster_FRA_FR_SM02_for pub | 29OCT2025 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Poster_ITA_IT_IN_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Poster_ROU_EN_SM02-RFI001_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Poster_ROU_RO_SM02_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Website_POL_PL_SM02_for pub | 16DEC2025 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR assent_ESP_ES_IN_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_FIN_FI_IN_for pub | 0.1 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_FRA_FR_IN-RFI007_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_HUN_HU_IN_for pub | 00R |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_NLD_NL_SM02_for pub | 0.01R |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_POL_PL_IN_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR information_FRA_FR_IN-RFI007_for pub | 0.01R |
| Subject information and informed consent form (for publication) | L1_ICF_Genetic consent_FRA_FR_SM02_for pub | AM01v1.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Genetic consent_HUN_HU_IN_for pub | 00R |
| Subject information and informed consent form (for publication) | L1_ICF_Genetic consent_Prescreen_HUN_HU_IN_for pub | 00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_DEU_DE_SM02_for pub | AM01v1.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_ESP_ES_SM02_for pub | AM01v1.01R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_FIN_FI_SM02-RFI006_for pub | 1.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_FRA_FR_SM02_for pub | AM01v1.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_HUN_HU_SM02_for pub | AM01v1.01R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_ITA_IT_SM02_for pub | AM01v1.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_NLD_NL_SM02_for pub | AM01v1.01R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_POL_PL_SM02-RFI003_for pub | AM01v1.01R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_ROU_EN_SM02_for pub | AM01v1.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_ROU_RO_SM02_for pub | AM01v1.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main data privacy_ITA_IT_IN_for pub | 14MAR2025 |
| Subject information and informed consent form (for publication) | L1_ICF_Main information_FRA_FR_SM02_for pub | AM01v1.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_add crossborder_DEU_DE_IN_for pub | 28May2025R |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_data privacy_limited screening_ITA_IT_IN_for pub | 14MAR2025 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_DILI sample_ITA_IT_IN_for pub | 27FEB2025 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_ROU_EN_IN_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_ROU_RO_IN_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_DEU_DE_SM02_for pub | AM02v2.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_ESP_ES_SM02_for pub | AM02v2.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_FRA_FR_SM02_for pub | AM02v2.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_ITA_IT_SM02_for pub | AM02v2.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_NLD_NL_SM02_for pub | AM02v2.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_POL_PL_SM02-RFI003_for pub | AM02v2.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_ROU_EN_SM02_for pub | AM02v2.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_ROU_RO_SM02_for pub | AM02v2.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening information_FRA_FR_SM02_for pub | AM02v2.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnancy follow-up_ESP_ES_IN-RFI013_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner data privacy_ITA_IT_IN-RFI006_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner_ESP_ES_IN-RFI013_for pub | 00R |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner_FIN_FI_SM02_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner_HUN_HU_IN_for pub | 0.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner_ITA_IT_IN-RFI006_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_prescreening_HUN_HU_SM02_for pub | AM02v1.00R |
| Subject information and informed consent form (for publication) | L2_Patient emergency card_FRA_FR_IN-RFI007_for pub | 2.0.00.00 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC RSI_5-FLUOROURACIL Hospira UK LTD_SM02_for pub | 20JAN2025 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC RSI_BEVACIZUMAB_IN_for pub | Roche P.L. |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC RSI_CETUXIMAB Merck Serono_SM02_for pub | 03SEP2025 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC RSI_LEUCOVORIN_IN_for pub | MEDAC GMBH |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC RSI_LEVOLEUCOVORIN_IN_for pub | MEDAC GMBH |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC RSI_MVASI_ Amgen Technology Ireland_SM02_for pub | 16OCT2025 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC RSI_OXALIPLATIN Sun Pharmaceuticals Uk Ltd_SM02_for pub | 27JUN2025 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-517232-22_DEU_DE_SM02_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-517232-22_ESP_ES_SM02_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-517232-22_FRA_FR_SM02_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-517232-22_HUN_HU_SM02_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-517232-22_ITA_IT_SM02_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-517232-22_NLD_NL_SM02_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-517232-22_POL_PL_SM02_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-517232-22_ROU_RO_SM02_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-517232-22_SM02_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_2024-517232-22_HUN_HU_SM02-RFI005_for pub | 02R |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_2024-517232-22_ROU_RO_IN_for pub | 01R |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-02 | Spain | Acceptable with conditions 2025-09-15
|
2025-09-17 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-09-29 | Acceptable with conditions 2025-09-15
|
2025-09-29 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-09-30 | Acceptable with conditions 2025-09-15
|
2025-09-30 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-09-30 | Acceptable with conditions 2025-09-15
|
2025-09-30 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-10-03 | Spain | Acceptable with conditions 2025-09-15
|
2025-10-03 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-11-04 | Spain | Acceptable with conditions 2025-09-15
|
2025-11-04 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-12-10 | Spain | Acceptable with conditions 2025-09-15
|
2025-12-10 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2026-01-06 | Acceptable with conditions 2025-09-15
|
2026-01-06 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-01-22 | Spain | Acceptable 2026-04-30
|
2026-05-01 |