Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
566
Countries
6
Sites
40
Pancreatic ductal adenocarcinoma
To evaluate the efficacy of autogene cevumeran + atezolizumab + mFOLFIRINOX compared with mFOLFIRINOX based on disease-free survival (DFS) after randomization
Key facts
- Sponsor
- Genentech Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 3 Jun 2024 → ongoing
- Decision date (initial)
- 2023-12-19
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Genentech Inc.
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
To evaluate the efficacy of autogene cevumeran + atezolizumab + mFOLFIRINOX compared with mFOLFIRINOX based on disease-free survival (DFS) after randomization
Secondary objectives 2
- To evaluate the efficacy of autogene cevumeran + atezolizumab + mFOLFIRINOX compared with mFOLFIRINOX based on DFS rates at 12, 24, and 36 months, overall survival (OS) after randomization, and OS rates at 3 and 5 years
- To evaluate the safety of autogene cevumeran + atezolizumab + mFOLFIRINOX compared with mFOLFIRINOX
Conditions and MedDRA coding
Pancreatic ductal adenocarcinoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10051971 | Pancreatic adenocarcinoma | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Preoperative diagnosis of resectable PDAC tumor
- Histologically confirmed diagnosis of PDAC
- Pancreatic cancer tumor, lymph node, metastasis (TNM) pathological staging values of T1-T3, N0-N2, and M0 per the American Joint Committee on Cancer (AJCC) Staging Manual, 8th edition
- Macroscopically complete (R0 or R1) resection of PDAC
- Unequivocal absence of disease after surgery as assessed by the investigator and based on review of all available data including mandatory imaging [computed tomography (CT) or magnetic resonance imaging (MRI) scans], biochemical data, and clinical findings within 28 days prior to randomization
- Carbohydrate antigen 19-9 (CA19-9) level measured within 14 days prior to initiation of study treatment
Exclusion criteria 6
- Prior adjuvant, neoadjuvant, or induction treatment for pancreatic cancer, including cytotoxic chemotherapy, immunotherapy, investigational therapy, or radiation therapy
- Absence of spleen (due to splenectomy, splenic injury/infarction, or functional asplenia)
- Active or history of autoimmune disease or immune deficiency
- Unresolved >=Grade 3 postoperative complication(s) per the Clavien-Dindo Classification of Surgical Complications
- Pregnancy or breastfeeding , or intention of becoming pregnant during study treatment or within 28 days after the final dose of autogene cevumeran, 9 months after the last dose of chemotherapy, or 5 months after the final dose of atezolizumab, (15 months after the final dose of oxaliplatin in Korea) whichever period ends later
- Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 1. DFS after randomization
Secondary endpoints 6
- 1. OS after randomization
- 2. DFS rates at 12, 24, and 36 months
- 3. OS rates at 3 and 5 years
- 4. Incidence and severity of adverse events, with severity determined according to National Cancer Institute's Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) grading scale
- 5. Change from baseline in targeted vital signs
- 6. Change from baseline in targeted clinical laboratory test results
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
—
PRD11037991 · Product
- Other product name
- AUTOGENE CEVUMERAN
- Authorisation status
- Not Authorised
- MA holder
- GENENTECH, INC.
- Paediatric formulation
- No
- Orphan designation
- No
—
PRD7537922 · Product
- Authorisation status
- Authorised
- Marketing authorisation
- EU/1/17/1220/002
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary packaging and labelling for clinical trial use
Comparator 14
—
PRD675162 · Product
- Authorisation status
- Authorised
- Marketing authorisation
- OGYI-T-4272/10
- MA holder
- TEVA GYÓGYSZERGYÁR ZRT
- MA country
- Hungary
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary packaging and labelling for clinical trial use
—
PRD595959 · Product
- Authorisation status
- Authorised
- Marketing authorisation
- 6117.01.00
- MA holder
- TEVA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary packaging and labelling for clinical trial use
—
PRD1186036 · Product
- Authorisation status
- Authorised
- Marketing authorisation
- 89351.00.00
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary packaging and labelling for clinical trial use
—
PRD536079 · Product
- Authorisation status
- Authorised
- Marketing authorisation
- 41196.00.00
- MA holder
- MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary packaging and labelling for clinical trial use
—
PRD415412 · Product
- Substance synonyms
- 5-FLUORO-1H-PYRIMIDINE-2,4-DIONE, 5-FLUOROURACIL, 5-FU, 5-FLOUROURACIL
- Authorisation status
- Authorised
- Marketing authorisation
- 34009 575 181 1 0
- MA holder
- ACCORD HEALTHCARE FRANCE SAS
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary packaging and labelling for clinical trial use
—
PRD2947832 · Product
- Authorisation status
- Authorised
- Marketing authorisation
- 55983.00.00
- MA holder
- BENDALIS GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary packaging and labelling for clinical trial use
—
PRD2832960 · Product
- Authorisation status
- Authorised
- Marketing authorisation
- 44048.05.00
- MA holder
- BENDALIS GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary packaging and labelling for clinical trial use
—
PRD7219385 · Product
- Authorisation status
- Authorised
- Marketing authorisation
- HR-H-636486129
- MA holder
- PLIVA HRVATSKA D.O.O.
- MA country
- Croatia
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary packaging and labelling for clinical trial use
—
PRD595980 · Product
- Authorisation status
- Authorised
- Marketing authorisation
- 12806.00.00
- MA holder
- TEVA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary packaging and labelling for clinical trial use
—
PRD3022873 · Product
- Authorisation status
- Authorised
- Marketing authorisation
- 79926.00.00
- MA holder
- AQVIDA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary packaging and labelling for clinical trial use
—
PRD5524458 · Product
- Authorisation status
- Authorised
- Marketing authorisation
- 34009 550 423 5 8
- MA holder
- ACCORD HEALTHCARE FRANCE SAS
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary packaging and labelling for clinical trial use
—
PRD4609429 · Product
- Authorisation status
- Authorised
- Marketing authorisation
- 34009 576 842 1 1
- MA holder
- ACCORD HEALTHCARE FRANCE SAS
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary packaging and labelling for clinical trial use
—
PRD731441 · Product
- Authorisation status
- Authorised
- Marketing authorisation
- 66264.00.00
- MA holder
- TEVA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary packaging and labelling for clinical trial use
—
PRD1874310 · Product
- Authorisation status
- Authorised
- Marketing authorisation
- 88845.00.00
- MA holder
- AQVIDA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary packaging and labelling for clinical trial use
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Genentech Inc.
- Sponsor organisation
- Genentech Inc.
- Address
- 1 Dna Way
- City
- South San Francisco
- Postcode
- 94080-4990
- Country
- United States
Scientific contact point
- Organisation
- Genentech Inc.
- Contact name
- US Program Manager Product Development Regulatory
Public contact point
- Organisation
- Genentech Inc.
- Contact name
- US Program Manager Product Development Regulatory
Third parties 12
| Organisation | City, country | Duties |
|---|---|---|
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Other |
| Bioclinica Inc. ORG-100033079
|
Princeton, United States | Other |
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Other |
| WCG IRB ORL-000001107
|
Puyallup, United States | Other |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Transperfect Translations International Inc. ORG-100043494
|
New York, United States | Other |
| Worldcare Clinical LLC ORG-100047766
|
Waltham, United States | Other |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | Other |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| Pharmaspecific ORG-100043438
|
Champs-Sur-Marne, France | Other |
| Precision For Medicine Inc. ORG-100041895
|
Frederick, United States | Other |
| BioNTech SE ORG-100014714
|
Mainz, Germany | Other |
Locations
6 EU/EEA countries · 40 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 19 | 5 |
| France | Ongoing, recruiting | 38 | 7 |
| Germany | Ongoing, recruiting | 85 | 13 |
| Netherlands | Ongoing, recruiting | 22 | 3 |
| Spain | Ongoing, recruiting | 31 | 10 |
| Sweden | Ongoing, recruiting | 9 | 2 |
| Rest of world
Canada, Korea, Republic of, United Kingdom, United States
|
— | 362 | — |
Investigational sites
UZ Leuven
Digestive Oncology, Herestraat 49, 3000, Leuven
Az Maria Middelares Gent
Digestive Oncology, Buitenring-Sint-Denijs 30, 9000, Gent
Hopital Erasme
Gastroenterology, Lennikse Baan 808, 1070, Anderlecht
Antwerp University Hospital
Klinische Digestieve Oncologie, Drie Eikenstraat 655, 2650, Edegem
Universitair Ziekenhuis Gent
Oncology, Corneel Heymanslaan 10, 9000, Gent
Centre Hospitalier Universitaire De Poitiers
Pole Régional de Cancérologie, 2 Rue De La Miletrie, 86000, Poitiers
Centre Hospitalier Universitaire De Bordeaux
Oncologie digestive, Avenue De Magellan, 33600, Pessac
Institut Gustave Roussy
Départment d'Innovation Thérapeutique, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Leon Berard
Oncologie chirurgicale, 28 Rue Laennec, 69008, Lyon
Institut Paoli-Calmettes
Oncologie digestive, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Centre Hospitalier Universitaire De Lille
Oncologie médicale, Rue Michel Polonovski, 59037, Lille Cedex
Institut De Cancerologie De Lorraine
Oncologie médicale, 6 Avenue De Bourgogne, 54500, Vandouvre-Les-Nancy
Krankenhaus Nordwest GmbH
Institut für Klinisch-Onkologische Forschung (IKF), Steinbacher Hohl 2-26, Praunheim, Frankfurt Am Main
Technische Universitat Dresden
Medizinische Klinik und Poliklinik I, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Muenchen Klinik gGmbH
Klinik für Gastroenterologie, Hepatologie und Gastroenterologische Onkologie, Englschalkinger Strasse 77, Bogenhausen, Munich
University Hospital Cologne AöR
Klinik fuer Gastroenterologie und Hepatologie, Kerpener Strasse 62, Lindenthal, Cologne
Klinikum der Universitaet Muenchen AöR
Krebszentrum - CCC MünchenLMU - Comprehensive Cancer Center, Marchioninistrasse 15, Hadern, Munich
University Medical Center Hamburg-Eppendorf
Zentrum für Onkologie - II. Medizinische Klinik und Poliklinik, Martinistrasse 52, Eppendorf, Hamburg
Universitaetsklinikum Tuebingen AöR
Medizinische Klinik Innere Medizin I, Otfried-Mueller-Strasse 10, Nordstadt, Tuebingen
Charite Universitaetsmedizin Berlin KöR
Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie u. Tumorimmunologie, Augustenburger Platz 1, Wedding, Berlin
Universitaetsklinikum Heidelberg AöR
Nationales Centrum für Tumorerkrankunngen (NCT), Im Neuenheimer Feld 460, Neuenheim, Heidelberg
Katholisches Klinikum Bochum gGmbH
St. Josef-Hospital Hämatologie und Onkologie mit Palliativmedizin, Gudrunstrasse 56, Grumme, Bochum
Universitaetsklinikum Essen AöR
Westdeutsches Tumorzentrum (WTZ), Hufelandstrasse 55, Holsterhausen, Essen
Universitaetsklinikum Wuerzburg AöR
Medizinische Klinik und Poliklinik II - Internistische Onkologie, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
Universitaetsklinikum Ulm AöR
Zentrum für Innere Medizin, Klinik für Innere Medizin I, Albert-Einstein-Allee 23, Eselsberg, Ulm
Radboud universitair medisch centrum / RADBOUDUMC
Medical Oncology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
VUmc Stichting
Medical Oncology, De Boelelaan 1117, 1081 HV, Amsterdam
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Internal Oncology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Hospital Universitario Central De Asturias
Oncology, Avenida De Roma S/n, 33011, Oviedo
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario Regional De Malaga
Oncology, Avenida De Carlos De Haya S/n, 29010, Malaga
Institut Catala D'oncologia
Oncology, Carretera Canyet S/n, 08916, Badalona
Hospital Universitario Ramon Y Cajal
Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Clinica Universidad De Navarra
Oncology, Avenue Pio XII 36, 31008, Pamplona
Clinica Universidad De Navarra
Oncology, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital General Universitario Gregorio Maranon
Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitari Vall D Hebron
Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, 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 |
|---|---|---|---|---|---|
| Belgium | 2025-01-31 | 2025-02-18 | |||
| France | 2024-06-03 | 2024-06-04 | |||
| Germany | 2024-07-17 | 2024-07-22 | |||
| Netherlands | 2024-11-05 | 2025-02-20 | |||
| Spain | 2024-06-12 | 2024-06-13 | |||
| Sweden | 2024-06-07 | 2024-10-09 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Serious breaches 1 · Art. 52 CTR
Serious breach SB-108733
- Sponsor became aware
- 2025-11-21
- Date of breach
- 2025-11-18
- Submission date
- 2025-11-28
- Member states concerned
- Belgium, France, Germany, Spain, Sweden, Netherlands
- Categories
- Protocol
- Areas impacted
- Subject safety
- Benefit-risk balance changed
- No
- Description
- As the description of serious breach exceeds the allowed 4000 characters, please refer to the text attached under the "supporting information" section.
- Sponsor actions
- The site immediately informed patient 27658 of the error and implemented the below safety checks:
● Patient was admitted to the inpatient ward for overnight observation.
● Additional blood tests and vital signs checked - all observations were normal.
On 19Nov2025, the site provided an update that the patient was well overnight with no symptoms of immune related adverse events. All observations were normal. The patient was discharged and the clinical site study team will follow up with the patient with a phone call over the next two days to check their condition.
Additionally, the below investigation/CAPA plan is underway:
● The CRO, Fortrea has opened a CAPA at the site.
● A major Protocol Deviation was reported on 19Nov2025.
● The site reported the incident in the eCRF as a special situation.
● Site CAPA actions to date:
● The site research team informed the Sponsor / PI of the incident; Pharmacy informed the Chief Pharmacist.
● Initial CAPA meeting between the Oncology Research Operations Manager, Head of Pharmacy Clinical Trials and Deputy Chief Pharmacist.
● Review of dispensing SOPs and procedures template – if manual dispensing is required on a study, clinical trials pharmacist or pharmacy technician must select the kit themselves with the dispenser.
● Freezer access will be under the direct supervision of a clinical trials pharmacist or pharmacy technician only.
● IMP log/stock location tracker will be updated with the correct IMP location details
● Refresher training and additional oversight will be implemented for all site staff involved in manually dispensing Clinical Trial medications to reduce the risk of similar errors in the future.
Site screening of new patients has been placed on hold until Health Authority submissions are completed and additional investigation and follow up activities have been conducted.
| Organisation | City | Country | Type |
|---|---|---|---|
| Hammersmith Hospital | London | United Kingdom | Clinical investigator, Clinical investigator, Clinical investigator, Clinical investigator |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 81 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2022-502404-73-00 Redacted | 5 |
| Protocol (for publication) | d1_protocol substudy-2022-502404-73-00-redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents_EQ5D5L_eCOA Tablet_BE-FR.pdf | 1 |
| Protocol (for publication) | D4_Patient facing documents_EQ5D5L_eCOA Tablet_BE-NL.pdf | 1 |
| Protocol (for publication) | D4_Patient facing documents_EQ5D5L_eCOA Tablet_DE.pdf | 1 |
| Protocol (for publication) | D4_Patient facing documents_EQ5D5L_eCOA Tablet_ES.pdf | 1 |
| Protocol (for publication) | D4_Patient facing documents_EQ5D5L_eCOA Tablet_FR.pdf | 1 |
| Protocol (for publication) | D4_Patient facing documents_EQ5D5L_eCOA Tablet_NL.pdf | 1 |
| Protocol (for publication) | D4_Patient facing documents_EQ5D5L_eCOA Tablet_SE.pdf | 1 |
| Recruitment arrangements (for publication) | K1_GO44479_Recruitment arrangements | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment and ICF process | NA |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent Procedure Form | NA |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangement | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | NA |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Infant | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main_Redacted | 9.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF PP | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Screening Part A_Redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_GO44479_FR_Substudy ICF_French | 2.0 |
| Subject information and informed consent form (for publication) | L1_GO44479_FR_Substudy RBR optional ICF_French | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum I to Main | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Appendix I Data Privacy | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Infant Health | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF_English_Redacted | 10.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional RBR | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Screening Part A_redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Screening_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Substudy Addendum I to Main | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Substudy Appendix I Data Privacy | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Substudy FBR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Substudy Main_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Substudy Main_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Substudy Optional RBR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Infant | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Infant Authorization | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Infant Autorisation Form ICF_Dutch for NLD_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Infant Autorisation Form ICF_Dutch__Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Infant Autorisation Form ICF_English_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Infant Autorisation Form ICF_French__Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Dutch for NLD_Redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Dutch_Redacted | 10.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_French_Redacted | 10.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner ICF_English_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_ICF_Dutch for NLD_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_ICF_Dutch_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_ICF_French_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_RBR optional | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Screening Part A | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Screening Part A ICF_Dutch for NLD_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Screening Part A ICF_Dutch_Redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Screening Part A ICF_English_Redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Screening Part A ICF_French_Redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Substudy ICF_Dutch for NLD_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_SubStudy_Main ICF_BE_Dutch_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_SubStudy_Main ICF_BE_English_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_SubStudy_Main ICF_BE_French_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and Substudy Main ICF_Redacted | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | e2_smpc-calcium-folinate | n/a |
| Summary of Product Characteristics (SmPC) (for publication) | e2_smpc-calcium-folinate-redline | n/a |
| Summary of Product Characteristics (SmPC) (for publication) | e2_smpc-fluorouracil | n/a |
| Summary of Product Characteristics (SmPC) (for publication) | e2_smpc-fluorouracil-redline | n/a |
| Summary of Product Characteristics (SmPC) (for publication) | e2_smpc-irinotecan_redline | NA |
| Summary of Product Characteristics (SmPC) (for publication) | e2_smpc-oxaliplatin_redline | NA |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Irinotecan | NA |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC oxaliplatin | NA |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE-DE-2022-502404-73-00 | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE-FR-2022-502404-73-00 | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE-NL-2022-502404-73-00 | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG-2022-502404-73-00 | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES-2022-502404-73-00 | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR-FR-2022-502404-73-00 | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NL-NL-2022-502404-73-00 | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_SE-SE-2022-502404-73-00 | 2.0 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-29 | Germany | Acceptable 2023-12-18
|
2023-12-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-01-09 | Germany | Acceptable | 2024-01-18 |
| 3 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-02-15 | Germany | Acceptable 2024-05-28
|
2024-05-29 |
| 4 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-06-14 | Germany | Acceptable 2024-08-19
|
2024-08-19 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-09-11 | Germany | Acceptable 2024-08-19
|
2024-09-11 |
| 6 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-01-08 | Germany | Acceptable 2025-03-10
|
2025-03-10 |
| 7 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-06-25 | Germany | Acceptable 2025-09-04
|
2025-09-04 |
| 8 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-10-10 | Germany | Acceptable 2025-12-08
|
2025-12-08 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-12-18 | Germany | Acceptable 2025-12-08
|
2025-12-18 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-04-01 | Germany | Acceptable 2025-12-08
|
2026-04-01 |