Overview
Sponsor-declared trial summary
Phase
Phase II and Phase III (Integrated)
Status
Ongoing, recruitment ended
Participants planned
470
Countries
15
Sites
90
Untreated Metastatic Pancreatic Ductal Adenocarcinoma
To test the ability of BMS-986504 + nab-p/gem to prolong the time to disease worsening on scans, and to prolong survival (Phase 3)
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
- 17 Dec 2025 → ongoing
- Decision date (initial)
- 2025-12-03
- 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
- 2025-522598-12-00
- WHO UTN
- U1111-1320-4708
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
To test the ability of BMS-986504 + nab-p/gem to prolong the time to disease worsening on scans, and to prolong survival (Phase 3)
Secondary objectives 1
- To test the efficacy of BMS-986504 + nab-p/gem
Conditions and MedDRA coding
Untreated Metastatic Pancreatic Ductal Adenocarcinoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10051971 | Pancreatic adenocarcinoma | 10029104 |
| 27.0 | LLT | 10033599 | Pancreatic adenocarcinoma metastatic | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Histologically or cytologically confirmed diagnosis of metastatic PDAC
- Evidence of homozygous MTAP deletion or MTAP loss detected in tumor tissue
- Metastatic disease with at least 1 measurable lesion as per RECIST v1.1
- Participants must not have received any systemic anticancer treatments in the metastatic setting (participants may receive up to one cycle of standard of care nab-p/gem prior to randomization)
- Participants must be >18 years of age at the time of signing consent
Exclusion criteria 4
- Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to screening
- Participants must not have an impairment in gastrointestinal function that may limit the ability to absorb or swallow an oral medication without chewing or crushing
- Participants must not have significant cardiovascular abnormalities or conditions withing 6 months prior to enrollment
- Confirmed and active viral infections including hepatitis and/or HIV
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Time to disease worsening on scans and time to death (Phase 3)
Secondary endpoints 1
- Rate of tumor shrinkage, duration of tumor shrinkage, time to tumor shrinkage, and rate of participants with control of tumor growth and/or shrinkage
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
SUB127678 · Substance
- Active substance
- Paclitaxel Albumin-Bound
- Pharmaceutical form
- POWDER FOR DISPERSION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 9999 mg/m2 milligram(s)/sq. meter
- Max total dose
- 9999 mg/m2 milligram(s)/sq. meter
- 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 over-labeled and repackaged.
PRD12193680 · Product
- Active substance
- 2-4-4-AMINOMETHYL-1-OXO-2H-PHTHALAZIN-6-YL-2-METHYLPYRAZOL-3-YL-4-CHLORO-6-CYCLOPROPYLOXY-3-FLUOROBENZONITRILE
- Pharmaceutical form
- FILM-COATED TABLET
- 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
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
SUB07892MIG · Substance
- Active substance
- Gemcitabine
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS 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 over-labeled and repackaged.
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- 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)
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
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 |
|---|---|---|
| Massive Bio Inc. ORG-100044618
|
New York, United States | Other |
| Accenture Services Pvt. Ltd. ORL-000000127
|
Bengaluru, India | Other |
| Azenta Germany GmbH ORG-100022621
|
Griesheim, Germany | Other |
| Clario ORL-000006274
|
Princeton, New Jersey, United States | Other |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Other |
| Discovery Life Sciences LLC ORG-100046461
|
Huntsville, United States | Other |
| Accenture Solutions Private Limited ORG-100032592
|
Bangaluru, India | Other, Data management |
| Labcorp Central Laboratory Services ORL-000001529
|
United States | Other |
| Endpoint Clinical Inc. ORL-000012879
|
Wakefield, United States | Other |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
Locations
15 EU/EEA countries · 90 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 6 | 3 |
| Belgium | Ongoing, recruitment ended | 10 | 7 |
| Czechia | Ongoing, recruitment ended | 9 | 6 |
| Denmark | Ongoing, recruitment ended | 6 | 3 |
| France | Ongoing, recruitment ended | 16 | 14 |
| Germany | Ongoing, recruitment ended | 26 | 10 |
| Greece | Authorised, recruiting | 11 | 7 |
| Ireland | Authorised, recruiting | 5 | 1 |
| Italy | Ongoing, recruitment ended | 18 | 9 |
| Netherlands | Authorised, recruiting | 6 | 4 |
| Poland | Ongoing, recruiting | 9 | 3 |
| Romania | Ongoing, recruitment ended | 17 | 9 |
| Slovakia | Authorised, recruitment pending | 8 | 3 |
| Spain | Ongoing, recruitment ended | 10 | 7 |
| Sweden | Ongoing, recruitment ended | 5 | 4 |
| Rest of world
Hong Kong, Taiwan, Colombia, Switzerland, Israel, Argentina, Canada, Chile, India, Singapore, China, United Kingdom, Korea, Republic of, Brazil, South Africa, Japan, United States, Australia, Mexico, Turkey, Malaysia
|
— | 308 | — |
Investigational sites
Ordensklinikum Linz GmbH
Internal I: Medical oncology and hematology, Seilerstaette 4, 4010, Linz
Medical University Of Vienna
Department of Medicine I, Clinical Division of Oncology, Waehringer Guertel 18-20, Alsergrund, Vienna
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
University Clinic for Internal Medicine III, Muellner Hauptstrasse 48, 5020, Salzburg
Universitair Ziekenhuis Gent
Gastro Enterology, Corneel Heymanslaan 10, 9000, Gent
Universitair Ziekenhuis Antwerpen
Oncology, Drie Eikenstraat 655, 2650, Edegem
Institut Jules Bordet
Gastroenterology, Mijlenmeersstraat 90, 1070, Anderlecht
UZ Leuven
Digestive Oncology, Herestraat 49, 3000, Leuven
Centre hospitalier universitaire de Liege
Medical oncology, Avenue De L'Hopital 1, 4000, Liege
Imelda
Medical oncology and hematology, Imeldalaan 9, 2820, Bonheiden
Cliniques Universitaires Saint-Luc
Gastroenterology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Masarykuv Onkologicky Ustav
Klinika komplexni onkologicke pece, Zluty Kopec 543/7, Stare Brno, Brno-Stred
Fakultni Nemocnice Hradec Kralove
Klinika onkologie a radioterapie, Sokolska 581, Novy Hradec Kralove, Hradec Kralove
Fakultni Thomayerova nemocnice
Onkologicka klinika, Videnska 800, Krc, Prague
University Hospital Olomouc
Onkologicka klinika, Zdravotniku 248/7, 779 00, Olomouc
Fakultni Nemocnice V Motole
Onkologicka klinika, V Uvalu 84/1, Motol, Prague
Vseobecna Fakultni Nemocnice V Praze
Onkologicka klinika, U Nemocnice 499/2, Nove Mesto, Prague
Sygehus Lillebaelt Vejle Sygehus
Onkologisk Afdeling, Beriderbakken 4, 7100, Vejle
Odense University Hospital
Department of Oncology, J. B. Winsloews Vej 4, 5000, Odense C
Region Hovedstaden
Department of Oncology, Herlev Ringvej 75, 2730, Herlev
University Hospital Of Clermont-Ferrand
Digestive Surgery and Oncology, 1 Place Lucie Et Raymond Aubrac, 63100, Clermont-Ferrand
CHU Besancon
Medical Oncology, 3 Boulevard Alexandre Fleming, 25000, Besancon
Institut Gustave Roussy
Medical Oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Hospitalier Universitaire De Poitiers
Gastro-enterology and medical oncology, 2 Rue De La Miletrie, 86000, Poitiers
Assistance Publique Hopitaux De Paris
Digestive Oncology, 20 Rue Leblanc, 75015, Paris
Assistance Publique Hopitaux De Paris
Oncology, 12 Avenue Paul Vaillant Couturier, 94800, Villejuif
Institut Regional Du Cancer De Montpellier
Medical Oncology, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5
Institut Curie
Medical Oncology, 26 Rue D Ulm, 75005, Paris
Hospices Civils De Lyon
Medical Oncology, 5 Place D Arsonval, 69437, Lyon Cedex 03
Centr Georges Francois Leclerc
Medical Oncology, 1 Rue Professeur Marion, 21000, Dijon
Institut Paoli Calmettes
Medical Oncology, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Centre Hospitalier Universitaire De Toulouse
Medical Oncology, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Centre Hospitalier De La Cote Basque
Hepatogastroenterology, 13 Avenue Interne Jacques Loeb, 64100, Bayonne
CHRU De Nancy
Gastroenterology, 11 Rue Du Morvan, Bp 80001, Vandoeuvre Les Nancy Cedex
Krankenhaus Nordwest GmbH
Institut für Klinisch-Onkologische Forschung (IKF), Steinbacher Hohl 2-26, Praunheim, Frankfurt Am Main
Universitaetsmedizin Goettingen
Klinik für Gastroenterologie, gastrointestinale Onkologie und Endokrinologie, Robert-Koch-Strasse 40, Weende, Goettingen
University Hospital Cologne AöR
Centrum für Integrierte Onkologie (CIO), Kerpener Strasse 62, Lindenthal, Cologne
DRK Kliniken Berlin
Klinik für Innere Medizin mit SP Gastro-, Hämato-und Onkologie, Salvador-Allende-Strasse 1-8, Koepenick, Berlin
Norddeutsches Studienzentrum für Innovative Onkologie (NIO)
Norddeutsches Studienzentrum für Innovative Onkologie (NIO), Eppendorfer Landstraße 42, 20249, Hamburg
Klinikum Chemnitz gGmbH
Klinik für Innere Medizin III, Flemmingstrasse 2, Altendorf, Chemnitz
Technische Universitaet Dresden
Medizinische Klinik I, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Katholisches Klinikum Bochum gGmbH
Klinik für Hämatologie, Onkologie und Palliativmedizin, Gudrunstrasse 56, Grumme, Bochum
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Klinik und Poliklinik für Innere Medizin II, Ismaninger Strasse 22, Au-Haidhausen, Munich
Universitaetsklinikum Ulm AöR
Klinik für Innere Medizin I, Albert-Einstein-Allee 23, Eselsberg, Ulm
General Hospital Of Thessaloniki Papageorgiou
Clinic of Medical Oncology, Ring Road Of Thessaloniki, Ministry Of Pavlos Melas, Efkarpia
University General Hospital Of Heraklion
Department of Internal Medicine-Oncology, Stavrakia And Voutes, 715 00, Heraklion
Areteio Hospital
2nd Surgical Clinic, Oncology Unit, Vassilissas Sofias Avenue 76, 115 28, Athens
Athens Medical Center S.A.
Oncology Department, Adersen 1, 115 25, Athens
Alexandra Hospital
Oncology Department, Vassilissas Sofias Avenue 80, 115 28, Athens
Theageneio Cancer Hospital
2nd Medical Oncology Department, Simeonidi Alex 2, 546 39, Thessaloniki
General University Hospital Of Larissa
Oncology Clinic, Chemotherapy Department, P. O. Box 1425, 411 10, Larissa
St Vincent's University Hospital
Medical Oncology, Elm Park Merrion Road, D04 T6F4, Dublin 4
Azienda Ospedaliero Universitaria Pisana
U.O. Oncologia Medica 2, Via Roma 67, 56126, Pisa
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
SSD Gruppo di Patologia Gastroenterico, Via Piero Maroncelli 40, 47014, Meldola
Istituto Oncologico Veneto
UOC Oncologia 1, Via Gattamelata 64, 35128, Padova
Humanitas Mirasole S.p.A.
HepatoPancreatoBiliary Oncology Medical Oncology and Hematology Unit, Via Francesco Nava 31, 20159, Milan
Fondazione IRCCS Istituto Nazionale Dei Tumori
S.C. ONCOLOGIA MEDICA 1, Via Giacomo Venezian 1, 20133, Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Oncologia Medica, Largo Francesco Vito 1, 00168, Rome
Ospedale San Raffaele S.r.l.
Oncologia Medica, Via Olgettina 60, 20132, Milan
Azienda Ospedaliera Universitaria Federico II Di Napoli
Oncologia Medica, Via Sergio Pansini 5, 80131, Naples
Centro Ricerche Cliniche Di Verona S.r.l.
Oncology unit, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Leids Universitair Medisch Centrum (LUMC)
Oncology, Albinusdreef 2, 2333 ZA, Leiden
Amphia Hospital
Oncology, Molengracht 21, 4818 CK, Breda
Academisch Ziekenhuis Maastricht
Medical Oncology, P Debyelaan 25, 6229 HX, Maastricht
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Medical Oncology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Copernicus Podmiot Leczniczy Sp. z o.o.
Wojewodzkie Centrum Onkologii Oddział Onkologii Klinicznej/Chemioterapii, Al. Zwyciestwa 31/32, 80-219, Gdansk
Mtz Clinical Research Powered By Pratia
N/A, Ul. Gładka 22, 02-172, Warsaw
Pratia S.A.
Pratia Poznań, Ul. Gryfinska 1, 60-192, Poznan
Institutul Clinic Fundeni
Oncology, Soseaua Fundeni 258, 022328, Bucharest
Spitalul Clinic Coltea
Oncology, Bulevardul Bratianu C. Ion 1-3, 030171, Bucharest
Centrul De Oncologie SF Nectarie S.R.L.
Oncology, Strada Caracal Nr 109, 200542, Craiova
Radiotherapy Center Cluj S.R.L.
Oncology, Str. Razoare Nr. 486g Jud. Cluj, 407280, Floresti
Institutul Regional De Gastroenterologie Hepatologie Prof. Dr. Octavian Fodor Cluj
Oncology, Strada Croitorilor 19-21, 400162, Cluj-Napoca
Spitalul Municipal Ploiesti
Oncology, Strada Ipatescu Ana Nr 59, 100337, Ploiesti
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Oncology, Strada Republicii 34-36, 400015, Cluj-Napoca
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
Vychodoslovensky Onkologicky Ustav a.s.
Clinical trials department, Rastislavova 43, Juh, Kosice
F D Roosevelt University General Hospital Of Banska Bystrica
Oncology Deparment, Namestie Ludvika Svobodu 1, 974 01, Banska Bystrica
National Oncology Institute
Dpt. of Clinical Oncology, Klenova 1, 833 10, Bratislava
Hospital Universitari Vall D Hebron
ONCOLOGIA, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario 12 De Octubre
ONCOLOGIA, Avenida De Cordoba Sn, 28041, Madrid
University Hospital Virgen Del Rocio S.L.
ONCOLOGIA, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario Hm Sanchinarro
ONCOLOGIA, Calle Ona 10, 28050, Madrid
Hospital General Universitario Gregorio Maranon
ONCOLOGIA, Calle Del Doctor Esquerdo 46, 28007, Madrid
Hospital Clinic De Barcelona
ONCOLOGIA, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Miguel Servet
ONCOLOGIA, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
Region Skane Skanes Universitetssjukhus
Kliniska forskningsenheten, KFE VO Hematologi, onkologi och strålningsfysik, Entregatan 7, 222 42, Lund
Uppsala University Hospital
Kliniska forsknings och utvecklingsenheten, KFUE, Blod och tumörsjukdomar, Akademiska Sjukhuset, 751 85, Uppsala
Karolinska University Hospital
Karolinska universitetssjukhuset, Medicinsk Enhet Övre Buk, Halsovagen, Flemingsberg, Huddinge
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Verksamhet Onkologi, Sahlgrenska Universitetssjukhuset, 413 45 Göteborg, Sverige, 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 | 2025-12-17 | 2025-12-22 | 2026-05-05 | ||
| Belgium | 2026-04-09 | 2026-04-09 | 2026-05-05 | ||
| Czechia | 2026-02-09 | 2026-04-27 | 2026-05-05 | ||
| Denmark | 2026-01-15 | 2026-04-13 | 2026-05-05 | ||
| France | 2025-12-18 | 2025-12-24 | 2026-05-05 | ||
| Germany | 2025-12-17 | 2025-12-19 | 2026-05-05 | ||
| Greece | 2026-02-16 | ||||
| Ireland | 2026-03-18 | ||||
| Italy | 2025-12-19 | 2026-02-19 | 2026-05-05 | ||
| Netherlands | 2026-05-13 | ||||
| Poland | 2026-01-19 | 2026-05-25 | |||
| Romania | 2026-01-15 | 2026-01-16 | 2026-05-05 | ||
| Spain | 2025-12-19 | 2026-01-05 | 2026-05-05 | ||
| Sweden | 2026-01-06 | 2026-04-17 | 2026-05-05 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 174 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1 Protocol 2025-522598-12-00_GR_Redacted | 02 EU |
| Protocol (for publication) | D1_Protocol 2025-522598-12-00_redacted | EU 02 |
| Recruitment arrangements (for publication) | K_Recruitment arrangements_DK | 1 |
| Recruitment arrangements (for publication) | K1 Recruitment Arrangements_GR | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_NL_Recruitment arrangements | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_AT | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_BE | 1.0 |
| 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_FR | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_IE_ENG | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_IT | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_PL | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_SK | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_IE_ENG | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_brochure_AT | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_Doctor to Patient Email | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_Doctor to Patient Letter | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_Dr to Patient Email_AT | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_Dr to Patient Letter_AT | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_Patient One Sheeter | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_Patient One Sheeter_AT | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_poster_AT | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_Recruitment Brochure | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_Recruitment Poster | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Additional_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main_Redacted | 2 |
| 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 Participant_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnant Partner_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Treatment Beyond Progression | 1 |
| Subject information and informed consent form (for publication) | L1_AT_SIS and ICF_site contact details_CL | 1 |
| Subject information and informed consent form (for publication) | L1_DK Add IC Right not to know_no redactions | 1 |
| Subject information and informed consent form (for publication) | L1_NL_SIS and ICF Additional ICF_Redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_NL_SIS and ICF Main IC_Redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_NL_SIS and ICF Pregnant Participant_Redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_NL_SIS and ICF Pregnant Partner_Redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_NL_SIS and ICF Treatment Beyond Progression | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Additional ICF_FR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Additional ICF_TC_FR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Additional IE_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Additional_GR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Additional_PL_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Additional_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF MAIN ES | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main IE_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_FR_Redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_GR_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 Main_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_TC_FR_Redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research_GR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research_PL_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Sample Collection IE_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Sample Collection_GR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Sample_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Samples_FR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Samples_PL_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Samples_TC_FR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional_Research_FR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional_Research_TC_FR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Participant who Becomes Pregnant_PL_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-Screening_GR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant IE_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant participant_FR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant participant_GR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant participant_TC_FR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner IE_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant partner_FR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant partner_GR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_PL_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant partner_TC_FR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Reimbursement_GR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment Beyond Progression IE | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment Beyond Progression_FR | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment beyond progression_GR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment Beyond Progression_no redaction | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment Beyond Progression_PL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment Beyond Progression_TC_FR | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Additional ES_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Additional ICF_Redacted_AT | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Additional ICF_redacted_DE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Additional_CZ_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Additional_ITA_Redatto | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Additional IC_ENG | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Additional ICF_FRA | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Additional ICF_NLD | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Main ICF_ENG | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Main ICF_ENG_Sponsorstatement BMS | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Main ICF_FRA | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Main ICF_NLD | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Optional sample Collection ICF_ENG | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Optional sample collection ICF_FRA | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Optional Sample collection ICF_NLD | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Pregnant Partner ICF_ENG | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Pregnant Partner ICF_FRA | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Pregnant Partner ICF_NLD | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_TBP ICF_ENG | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_TBP ICF_FRA | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_TBP ICF_NLD | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future Research IE_Redacted | 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 ICF_Redacted_AT | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_redacted_DE | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_MAIN TC ES | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_CZ_redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_MAIN_ITA_Redatto | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional FR ICF_redacted_DE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Future Research ICF_Redacted_AT | 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 Future Research_ITA_Redatto | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Sample Collection 1_ES_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Sample Collection 2 ES_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Sample Collection ICF_Redacted_AT | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Sample Collection ITA_Redatto | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Sample ICF_redacted_DE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Sample Sample Collection_CZ_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant ICF_Redacted_AT | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant ICF_redacted_DE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant_CZ_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant_ES_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant_ITA_Redatto | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner ICF_Redacted_AT | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner ICF_redacted_DE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_CZ_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_ES_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_ITA_Redatto | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_privacy_ITA_Redatto | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Reimbursement_ITA | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_TBP ICF_AT | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_TBP ICF_DE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Trattamento dati personali Additional_ITA_Redatto | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment Beyond Progression_CZ_public | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment beyond progression_ES | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment beyond progression_ITA | 1 |
| Subject information and informed consent form (for publication) | L1_SIS ICF Additional_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS ICF Future Research_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS ICF Main_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS ICF Optional Sample Collection_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS ICF Pregnant Partner_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS ICF Treatment Beyond Progression_Clean | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Additional_SK_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Data protection_SK_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Main_SK_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Opt Future Research_SK_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Opt Sample Collection_SK_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Preg Participant_SK | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Preg Partner_SK_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Treatment Beyond Progression_SK | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PDP_CZ_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF Mural Health Reimbursement data privacy IE | 1.0 |
| Subject information and informed consent form (for publication) | L2_SIS_Dine rettigheder som forsgsperson i forsg med medicin_DK | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Gemcitabine powder Fresenius Kabi | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Nab-paclitaxel Abraxane BMS 1 | 1 |
| Synopsis of the protocol (for publication) | D1 Protocol Synopsis 2025-522598-12-00_GR | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2025-522598-12_CZ_CS_public | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2025-522598-12_NL | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis 2025-522598-12-00_AT | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis 2025-522598-12-00_EN | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2025-522598-12-00_ES | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis 2025-522598-12-00_IT | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis PL 2025-522598-12_PL | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-522598-12_de_BE | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-522598-12_FR | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-522598-12_fr_BE | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-522598-12_nl_BE | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-522598-12_RO | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-522598-12_SK_SK | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EU CT 2025-522598-12_SE | 2 |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-08-07 | Germany | Acceptable 2025-11-28
|
2025-11-28 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-12-04 | Germany | Acceptable 2025-11-28
|
2025-12-04 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-12-05 | Acceptable 2025-11-28
|
2025-12-05 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-12-08 | Acceptable 2025-11-28
|
2025-12-08 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-12-12 | Acceptable 2025-11-28
|
2025-12-12 | |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-12-12 | Acceptable 2025-11-28
|
2025-12-12 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-12-16 | Acceptable | 2026-01-12 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2026-01-12 | Germany | Acceptable | 2026-01-12 |
| 9 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-01-19 | Germany | Acceptable 2026-04-13
|
2026-04-13 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2026-04-28 | Acceptable 2026-04-13
|
2026-04-28 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-04-29 | Germany | Acceptable | 2026-05-04 |