Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruitment pending
Participants planned
503
Countries
9
Sites
103
Carcinoma, Transitional Cell
The purpose of this study is to test a new medicine, vepugratinib, in comparison with placebo, to see if it is safe and can help people with a bladder cancer that is advanced or has spread. Vepugratinib or placebo will be administered in combination with enfortumab vedotin and pembrolizumab. Study participation could l…
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2026-04-21
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-522855-25-00
- WHO UTN
- U1111-1328-1470
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Safety, Efficacy
The purpose of this study is to test a new medicine, vepugratinib, in comparison with placebo, to see if it is safe and can help people with a bladder cancer that is advanced or has spread.
Vepugratinib or placebo will be administered in combination with enfortumab vedotin and pembrolizumab.
Study participation could last up to approximately 6 years.
Conditions and MedDRA coding
Carcinoma, Transitional Cell
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- A type of cancer called urothelial cancer that has spread to other parts of your body and cannot be removed with surgery
- A specific genetic change in the FGFR3 gene that can be found in a tumor or blood sample
- Tumors that can be measured by a doctor using a special system called RECIST v1.1
- Moderate to good level of physical ability
- Adequate laboratory test results
Exclusion criteria 5
- Have already had treatment for cancer that has spread to other parts of your body
- Still have side effects from previous cancer treatment that are worse than mild
- Have nerve damage that affects your senses or movement
- Have cancer that has spread to the brain that is untreated or uncontrolled
- Have eye problems like corneal keratopathy or retinal disorder that are symptomatic or haven't been treated yet
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- Safety Lead-in:Safety and Tolerability of vepugratinib in combination with EV and pembrolizumab
- Safety Lead-in:Overall Response Rate (ORR)
- Progression-free Survival (PFS) by Blinded Independent Central Review (BICR)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
PRD12339913 · Product
- Active substance
- (S-4-4-3-CHLORO-4-1-5-FLUOROPYRIDIN-2-YL-2-HYDROXYETHOXYPYRAZOLO15-APYRIDIN-6-YL-5-METHYL-1H-123-TRIAZOL-1-YLPIPERIDINE-1-CARBONITRILE
- Other product name
- Loxo-435
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 294000 mg milligram(s)
- Max treatment duration
- 735 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD10158656 · Product
- Active substance
- LOXO-435
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 294000 mg milligram(s)
- Max treatment duration
- 735 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD10158639 · Product
- Active substance
- LOXO-435
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 294000 mg milligram(s)
- Max treatment duration
- 735 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 2
—
SCP6094344 · ATC
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 7000 mg milligram(s)
- Max treatment duration
- 735 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01FF02 — PEMBROLIZUMAB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
SCP56433228 · ATC
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 1.25 mg/kg milligram(s)/kilogram
- Max total dose
- 6125 mg/kg milligram(s)/kilogram
- Max treatment duration
- 735 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01FX13 — ENFORTUMAB VEDOTIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Eli Lilly & Co.
- Sponsor organisation
- Eli Lilly & Co.
- Address
- 1 Lilly Corporate Center
- City
- Indianapolis
- Postcode
- 46285-0001
- Country
- United States
Scientific contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Public contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Third parties 13
| Organisation | City, country | Duties |
|---|---|---|
| Caerus US 1 Inc. ORG-100048366
|
New York, United States | Other |
| The Hibbert Co. ORG-100047639
|
Trenton, United States | Other |
| Clinical AI Inc ORL-000016741
|
United States | Other |
| Q2 Solutions LLC ORG-100017000
|
Ithaca, United States | Laboratory analysis |
| Tempus AI Inc. ORG-100044006
|
Chicago, United States | Laboratory analysis |
| Arup Laboratories Inc. ORG-100041750
|
Salt Lake City, United States | Laboratory analysis |
| Florence Healthcare Inc. ORL-000016740
|
Atlanta, United States | Other |
| Mural Health Technologies Inc. ORG-100051510
|
Berwyn, United States | Other |
| Iqvia Biotech LLC ORG-100008704
|
Durham, United States | On site monitoring |
| Bioclinica Inc. ORG-100033079
|
Philadelphia, United States | Laboratory analysis |
| Thermo Fisher Clinical Services ORL-000016742
|
United States | Other |
| PPD (Thermo Fisher Clinical Scientific) ORL-000016743
|
Belgium | Laboratory analysis |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Other |
Locations
9 EU/EEA countries · 103 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Authorised, recruitment pending | 16 | 6 |
| Denmark | Authorised, recruitment pending | 5 | 5 |
| France | Authorised, recruitment pending | 24 | 12 |
| Germany | Authorised, recruitment pending | 28 | 25 |
| Hungary | Authorised, recruitment pending | 18 | 5 |
| Italy | Authorised, recruitment pending | 27 | 8 |
| Netherlands | Authorised, recruitment pending | 8 | 4 |
| Poland | Authorised, recruitment pending | 15 | 12 |
| Spain | Authorised, recruitment pending | 56 | 26 |
| Rest of world
Canada, China, United Kingdom, Brazil, Taiwan, Australia, Japan, Korea, Republic of, Turkey
|
— | 306 | — |
Investigational sites
Fakultni Thomayerova nemocnice
Onkologická klinika 1. LF UK a FTN, Videnska 800, Krc, Prague
Fakultni Nemocnice Hradec Kralove
Klinika onkologie a radioterapie (budova č. 23), Sokolska 581, Novy Hradec Kralove, Hradec Kralove
University Hospital Olomouc
Onkologická klinika, Zdravotniku 248/7, 779 00, Olomouc
Masarykuv Onkologicky Ustav
Klinika komplexní onkologické péče, Zluty Kopec 543/7, Stare Brno, Brno-Stred
Fakultni Nemocnice Kralovske Vinohrady
Onkologická klinika, Srobarova 1150/50, Vinohrady, Prague
Fakultni Nemocnice V Motole
Onkologická klinika, V Uvalu 84/1, Motol, Prague
Rigshospitalet
Urooncology, Blegdamsvej 9, 2100, Copenhagen Oe
Herlev and Gentofte Hospital
Oncology, Borgmester Ib Juuls Vej 1, 2730, Copenhagen
Aarhus University Hospital
Oncology, Palle Juul-Jensens Boulevard 99,, 8200, Aarhus
Næstved Hospital
N/A, Ringstedgade 61, 4700, Næstved
Aalborg University Hospital
Oncology, Hobrovej 18-22, 9000, Aalborg
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Oncology, 229 Cours de l'Argonne, Bordeaux, Bordeaux
CHRU de Brest
Institut de cancérologie et d'Hématologie, Bd Tanguy Prigent, Hôpital de la Cavale Blanche, Brest
Centre Oscar Lambret
Oncology, 3 Rue Frédéric Combemale, Lille, Lille
Hospices Civils De Lyon
Oncology, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Centre Hospitalier Universitaire De Bordeaux
Service d'oncologie medicale, 1 Rue Jean Burguet, Cs 11261, Bordeaux Cedex
Institut Gustave Roussy
Oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Leon Berard
Oncology, 28, Rue Laennec, Rhône-Alpes
Centre Hospitalier Universitaire de Nîmes - Institut de Cancérologie du Gard - Hôpital Universitaire
Medical Oncology, Rue du Professeur Henri Pujol, Nîmes Gard, Nîmes
Oncopole Claudius Regaud
Oncology, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Institut de Cancérologie de l'Ouest
Oncology, 15, Rue André Bocquel, Angers
Centre Francois Baclesse
Oncology, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Institut Paoli-Calmettes
Oncology, 232 Boulevard Sainte Marguerite, Marseille, Marseille
Universitaetsklinikum Schleswig-Holstein AöR
Urology, Ratzeburger Allee 160, 23538, Luebeck
National Center For Tumor Diseases (NCT) Heidelberg
Oncology and/or Hematology, Im Neuenheimer Feld 460, Neuenheim, Heidelberg
Medical Center - University Of Freiburg
Urology, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
Klinikum Nuernberg
Oncology and/or Hematology, Prof.-Ernst-Nathan-Strasse 1, St. Johannis, Nuremberg
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR
N/A, Steinengrabenstrasse 17, 72622, Nuertingen
Studienzentrum Bayenthal Urologische Partnerschaft Köln
N/A, Bernhardstrasse 110, 50968, Cologne
University Medical Center Hamburg-Eppendorf
Onkologisches Zentrum, Martinistrasse 52, Eppendorf, Hamburg
Evangelisches Klinikum Bethel gGmbH
N/A, Schildescher Strasse 99, Schildesche, Bielefeld
Universitaetsklinikum Ulm AöR
Urology, Albert-Einstein-Allee 23, Eselsberg, Ulm
Universitaet Muenster
Urology, Albert-Schweitzer-Campus 1, Sentrup, Muenster
Universitaetsmedizin Greifswald KöR
N/A, Fleischmannstrasse 8, Noerdliche Muehlenvorstadt, Greifswald
Institut Fuer Versorgungsforschung In Der Onkologie GbR
N/A, Neversstrasse 5, Sued, Koblenz
Krankenhaus Nordwest GmbH
N/A, Steinbacher Hohl 2-26, Praunheim, Frankfurt Am Main
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Urology, Ismaninger Strasse 22, Au-Haidhausen, Munich
Universitaetsklinikum Duesseldorf AöR
Urology, Moorenstrasse 5, Bilk, Duesseldorf
HELIOS Klinikum Bad Saarow GmbH
N/A, Pieskower Strasse 33, 15526, Bad Saarow
Urologicum Duisburg Fachärztesozietät - Walsum
Urology, Fahrner Str.123, 47169, Duisburg
Universitaetsklinikum Tuebingen AöR
N/A, Hoppe-Seyler-Strasse 3, Nordstadt, Tuebingen
Universitaetsklinikum Essen AöR
N/A, Hufelandstrasse 55, Holsterhausen, Essen
Universitaetsklinikum Erlangen AöR
Urology, Rathsberger Strasse 57, Burgberg, Erlangen
Johanniter GmbH
Urology, Johanniterstrasse 3-5, Zentrum, Bonn
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Klinik und Poliklinik fuer Urologie, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Charite Universitaetsmedizin Berlin KöR
N/A, Chariteplatz 1, Mitte, Berlin
Universitaetsklinikum Wuerzburg AöR
Urology, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
Rostock University Medical Center
N/A, Schillingallee 35, Hansaviertel, Rostock
University Of Debrecen
Onkologiai Klinika, Nagyerdei Korut 98, 4032, Debrecen
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Onkoradiologia, Szent Istvan Utca 68, 4400, Nyiregyhaza
Orszagos Onkologiai Intezet
Urogenitalis Tumorok és Klinikai Farmakologiai Osztaly, Rath Gyorgy Utca 7-9, Kerulet, Budapest XII
Semmelweis University
Urologiai Klinika, Ulloi Ut 78/b, 1082, Budapest
University Of Szeged
Onkoterapias Klinika, Koranyi Fasor 12, 6720, Szeged
Istituto Oncologico Veneto
UOC Oncologia 3 - Dipartimento di Oncologia, Via Gattamelata 64, 35128, Padova
Azienda Ospedaliero Universitaria Pisana
U.O. Oncologia Medica 2 Universitaria, Via Roma 67, 56126, Pisa
Universita Cattolica Del Sacro Cuore
Medical Oncology, Largo Agostino Gemelli 8, 00168, Rome
Azienda Ospedaliera Universitaria Federico II Di Napoli
Oncologia Medica, Via Sergio Pansini 5, 80131, Naples
Fondazione IRCCS Istituto Nazionale Dei Tumori
Struttura Complessa Oncologia Medica 1, Via Giacomo Venezian 1, 20133, Milan
Istituto Nazionale Tumori Regina Elena
Oncologia Medica 1, Via Elio Chianesi 53, 00144, Rome
Ospedale San Raffaele S.r.l.
Oncologia Medica, Via Olgettina 60, 20132, Milan
Istituto Tumori Bari Giovanni Paolo II
Oncologia Medica, Viale Orazio Flacco 65, 70124, Bari
Radboud Translational Medicine B.V.
Medical Oncology, Geert Grooteplein Noord 21, Route 142, Nijmegen
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Medical Oncology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Amphia Hospital
Oncologie, Molengracht 21, 4818 CK, Breda
Amsterdam UMC Stichting
Medische Oncologie, De Boelelaan 1117, 1081 HV, Amsterdam
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
N/A, Ul. Szaserow 124, 04-141, Warsaw
Medical Concierge, Centrum Medyczne
N/A, ul. Polnej Róży 6/U2, 02-798, Warszawa
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Nowotworów Układu Moczowego, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Wsd Medi Clinical Sp. z o.o.
N/A, Aleja Jana Rodowicza Anody 22 Lok U 4, 02-786, Warsaw
Centrum Medyczne Luxmed Sp. z o.o.
Oddzial Onkologii Klinicznej/Chemioterapii, ul. Szamocka 6, 01-748, Warszawa
Pratia S.A.
N/A, Ul. Pana Tadeusza 2, 30-727, Cracow
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Oddzial Dzienny Chemioterapii, Ul. Tytusa Chalubinskiego 7, 75-581, Koszalin
Gyncentrum Sp. z o.o.
N/A, Ul. Wojska Polskiego 8a, 41-208, Sosnowiec
Szpital Grochowski Im.Dr Med. Rafała Masztaka Sp. z o.o.
Oddział Chemioterapii, Ul. Grenadierow 51/59, 04-073, Warsaw
Aidport Sp. z o.o.
N/A, Ul Ksiedza Stanisława Kozierowskiego 24, 60-185, Skorzewo
In Vivo Sp. z o.o.
N/A, Ul. Kaszubska 17h, 85-048, Bydgoszcz
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Oddział Kliniczny Urologii, Ul. Borowska 213, 50-556, Wroclaw
Hospital Universitari Sant Joan de Reus
Oncology, Avinguda Dr Josep Laporte 2, Reus
MD Anderson Cancer Center
Oncology, Calle De Arturo Soria Nº 270, 28033, Madrid
Hospital Arnau De Vilanova De Valencia
Unidad de Ensayos Clínicos, Calle De San Clemente 12, 46015, Valencia
Hospital Universitario Marques De Valdecilla
Medical Oncology, Avenida Valdecilla Sn, 39008, Santander
Hospital Clínico San Carlos
Oncology, C/ Martin Lagos s/n, Pabellon B, Madrid
Hospital De La Santa Creu I Sant Pau
Medical Oncology, Carrer De San Quinti 89, 08041, Barcelona
University Hospital Virgen Del Rocio S.L.
Medical Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario De Cruces
Medical Oncology, Cruces Plaza S/n, 48903, Barakaldo
Hospital General Universitario Gregorio Maranon
Oncology, Calle Del Doctor Esquerdo 46, 28007, Madrid
Complejo Hospitalario Universitario Insular Materno Infantil
Oncology, Autovia Del Sur S/n, 35017, Las Palmas De Gran Canaria
Institut Catala D'oncologia
Medical Oncology, Avinguda De Franca S/n, 17007, Girona
Hospital Universitario Ramon Y Cajal
Medical Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario Quironsalud Madrid
Medical Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitario Regional De Malaga
Oncology, Avenida De Carlos De Haya S/N, 29010, Malaga
Hospital Universitario De Navarra
Oncology, Irunlarrea Kalea 3, 31008, Pamplona
Hospital Universitari Vall D Hebron
Oncology - VHIO, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario 12 De Octubre
Medical Oncology, Avenida De Cordoba Sn, 28041, Madrid
Complexo Hospitalario Universitario De Santiago
Oncology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario De La Princesa
Medical Oncology, Calle De Diego De Leon 62, 28006, Madrid
Hospital General Universitario De Elche
Medical Oncology, Edificio 2, Camino De La Almazara 11, Elche
Hospital Universitario Reina Sofia
Medical Oncology, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Universitario De Badajoz
Medical Oncology, Avenida Elvas S/n, 06006, Badajoz
Hospital Clinic De Barcelona
ICHMO- Clinic Institut of Haematological and Oncological diseases, Calle Villarroel 170, 08036, Barcelona
Institut Catala D'oncologia
Medical Oncology, Carretera Canyet S/n, 08916, Badalona
Hospital Universitario La Paz
Medical Oncology, Paseo De La Castellana 261, 28046, Madrid
Institut Catala D'oncologia
Medical Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 96 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_redacted_2025-522855-25-00 | 1.0 |
| Protocol (for publication) | D4_Patient Documents Copyright Template | 1 |
| Recruitment arrangements (for publication) | K1_Additionnal Document_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Allocation | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1.1 |
| Recruitment arrangements (for publication) | K1_recruitment arrangements statement | 1.0 |
| Recruitment arrangements (for publication) | K1_recruitment arrangements statement | 1.0 |
| Recruitment arrangements (for publication) | K1_recruitment arrangements statement | 1 |
| Recruitment arrangements (for publication) | K1_recruitment arrangements statement | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Procedure | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment procedure | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Procedure_ | 1.0 |
| Recruitment arrangements (for publication) | K1_recruitment_arrangements_statement_PL | 1 |
| Recruitment arrangements (for publication) | K2_Brochure_Master_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Flyer_Master | 1 |
| Recruitment arrangements (for publication) | K2_Poster_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Brochure_Redacted | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Brochure_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Flyer | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Poster | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_Redacted | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_Redacted | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_EN_Site facing_Doctor Referral Slides | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_HU_Brochure_Redacted | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_HU_Flyer | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_HU_Poster | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_HU_Site facing_Doctor Referral Letter | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster | 2 |
| Recruitment arrangements (for publication) | K2_recruitment_material_Brochure_PL_Redacted | 2 |
| Recruitment arrangements (for publication) | K2_recruitment_material_Flyer_PL_Redacted | 2 |
| Recruitment arrangements (for publication) | K2_recruitment_material_Poster_PL_Redacted | 2 |
| Recruitment arrangements (for publication) | K3_Appreciation-Items | 2 |
| Recruitment arrangements (for publication) | K3_Recruitment material Flyer | 2.1 |
| Recruitment arrangements (for publication) | K4_Recruitment material Poster | 2.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF TC_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Addendum Genetic_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Main_Redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum Prescreening | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum Samples_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Activity - Screening_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Activity_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-Screening | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Optional Activity_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Screening | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future Research Addendum_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future Research ICF_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_JZVD_DPA ICF_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_JZVD_Main ICF_CZ_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_JZVD_Optional Activity - Future Research_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_main ICF_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Activity_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Prescreening ICF | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Preselection Process | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PL_Main ICF_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PL_Optional ICF_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PL_Prescreening ICF | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pre-screening Addendum | 1 |
| 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_Screening Activity_Clean | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and Main ICF_NL_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Main_ICF_Redacted | 1.3 |
| Subject information and informed consent form (for publication) | L2_Informed consent and patient recruitment procedure_PL | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Leaflet on trial subject rights | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Brochure_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Confidentiality Notice_Netherlands | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CT_Card_TY-Enrollment | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CT_Card_TY-Screening | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Flyer | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Poster | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Participant Contact Card | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study-Connect-Participant Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study-Guide_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Visit-Card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient Card text_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Patient Information Card CZ | 2.0 |
| Subject information and informed consent form (for publication) | L3_Info Re insurance Conditions for Patient | 2 |
| Subject information and informed consent form (for publication) | L3_Retention_HU_eCOA Participant Quick-Start Guide | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Keytruda | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Padcev | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-522855-25-00_ENG_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-522855-25-00_IT_Redacted | initial |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-522855-25-00_NL_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-522855-25-00_PL_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_CZ_2025-522855-25-00_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_HU 2025-522855-25-00_Redacted | initial |
| Synopsis of the protocol (for publication) | D1_Protocol_Synopsis_2025-522855-25-00_FR_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol_Synopsis_ES_2025-522855-25-00_Redacted | 1.0 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-08 | Denmark | Acceptable 2026-04-20
|
2026-04-20 |