Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
1,055
Countries
8
Sites
57
Patients with histologically or cytologically documented muscle-invasive transitional cell carcinoma (TCC) of the bladder
To assess efficacy of investigational product in patients with MIBC using pCR and EFS
Key facts
- Sponsor
- AstraZeneca AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 11 Feb 2019 → ongoing
- Decision date (initial)
- 2024-02-26
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- AstraZeneca AB, Sweden
External identifiers
- EU CT number
- 2023-510015-19-00
- EudraCT number
- 2018-001811-59
- ClinicalTrials.gov
- NCT03732677
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Pharmacokinetic, Safety
To assess efficacy of investigational product in patients with MIBC using pCR and EFS
Secondary objectives 1
- To assess efficacy and safety of investigational product in patients with MIBC using the following: EFS, pCR, EFS24 Proportion of patients who achieve
Conditions and MedDRA coding
Patients with histologically or cytologically documented muscle-invasive transitional cell carcinoma (TCC) of the bladder
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | n/a n/a
|
Randomised Controlled | None | Neoadjuvant And Adjuvant :Arm 1: ARM 1:Durvalumab + G+ C Q3W x 4 cycles(neoadjuvant) and Durvalumab Q4wx 8 (Adjuvant) -ARM 2: G+C Q3W(neoadjuvant) and No adjuvant treatment ((Adjuvant) Neoadjuvant And Adjuvant :Arm 2: ARM 2: G+C Q3W(neoadjuvant) and No adjuvant treatment ((Adjuvant) |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency, Food And Drug Administration
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Patient resectable muscle-invasive bladder cancer with clinical stage T2-T4aN0/1M0 with transitional and mixed transitional cell histology; Patients must be planning to undergo a radical cystectomy;Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of MIBC;ECOG performance status of 0 or 1 at enrollment.Availability of tumor sample prior to study entry; Must have a life expectancy of at least 12 weeks at randomization.
Exclusion criteria 1
- Evidence of lymph node (N2-N3) involvement or metastatic (M1) disease at the time of screening.Contra-indication to any of the study drugs;Requires immunosuppression medication for a concomitant condition;Active or prior documented autoimmune or inflammatory disorders
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- pCR;EFS
Secondary endpoints 1
- EFS, pCR, EFS24 Proportion of patients who achieve
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB176342 · Substance
- Active substance
- Durvalumab
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 1500 mg milligram(s)
- Max treatment duration
- 8 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 3
SUB07892MIG · Substance
- Active substance
- Gemcitabine
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07892MIG · Substance
- Active substance
- Gemcitabine
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07483MIG · Substance
- Active substance
- Cisplatin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 2
SUB02681MIG · Substance
- Active substance
- Infliximab
- Pharmaceutical form
- POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB03360MIG · Substance
- Active substance
- Mycophenolate Mofetil
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AstraZeneca AB
- Sponsor organisation
- AstraZeneca AB
- Address
- -
- City
- Sodertalje
- Postcode
- 151 85
- Country
- Sweden
Scientific contact point
- Organisation
- AstraZeneca AB
- Contact name
- AstraZeneca Clinical Study Information Center
Public contact point
- Organisation
- AstraZeneca AB
- Contact name
- AstraZeneca Clinical Study Information Center
Locations
8 EU/EEA countries · 57 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 20 | 6 |
| Czechia | Ongoing, recruitment ended | 33 | 5 |
| France | Ongoing, recruitment ended | 37 | 7 |
| Germany | Ongoing, recruitment ended | 62 | 11 |
| Italy | Ongoing, recruitment ended | 51 | 8 |
| Netherlands | Ongoing, recruitment ended | 35 | 3 |
| Poland | Ongoing, recruitment ended | 88 | 9 |
| Spain | Ongoing, recruitment ended | 77 | 8 |
| Rest of world
United Kingdom, Taiwan, Australia, Philippines, Russian Federation, Japan, Israel, United States, Brazil, Chile, Turkey, Canada, Vietnam, Korea, Republic of
|
— | 652 | — |
Investigational sites
UZ Leuven
General Medical Oncology, Herestraat 49, 3000, Leuven
Az St-Jan Brugge-Oostende A.V.
Oncology, Ruddershove 10, 8000, Brugge
Algemeen Ziekenhuis Delta
Medical Oncology, Deltalaan 1, 8800, Roeselare
Algemeen Ziekenhuis Groeninge
Oncology, President Kennedylaan 4, 8500, Kortrijk
Grand Hopital De Charleroi
Oncology & Hematology, Grand'rue 3, 6000, Charleroi
CHU De Liege
Medical Oncology, Avenue De L'hopital 1, 4000, Liege
Masarykuv Onkologicky Ustav
Klinika komplexní onkologické péče, Zluty Kopec 543/7, Stare Brno, Brno-Stred
Fakultni Nemocnice U Sv Anny V Brne
Onkologicko-chirurgické oddělení, Pekarska 53, Stare Brno, Brno-Stred
University Hospital Olomouc
Onkologická klinika, Zdravotniku 248/7, 779 00, Olomouc
Fakultni Nemocnice Hradec Kralove
Klinika onkologie a radioterapie, Sokolska 581, 500 03, Novy Hradec Kralove
Fakultni Thomayerova nemocnice
Onkologická klinika, Videnska 800, Krc, Prague 4
Centre Hospitalier Lyon Sud
Oncologie Medicale, Chemin Du Grand Revoyet, 69310, Pierre Benite
Centr Georges Francois Leclerc
Oncologie Medicale, 1 Rue Professeur Marion, 21000, Dijon
Centre De Cancerologue Du Grand Montpellier
Oncologie Medicale, 25 Rue De Clementville, 34070, Montpellier
Centre Hospitalier Universitaire De Nimes
Oncologie Medicale, 4 Place Du Professeur Robert Debre, Bp 40026, Nimes Cedex 9
Centre Hospitalier Universitaire D'Angers
Urologie, 4 Rue Larrey, 49100, Angers
Centre Hospitalier Universitaire Grenoble Alpes
Pole Cancer et Maladie du sang, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Centre Hospitalier Universitaire De Poitiers
Oncologie Medicale, 2 Rue De La Miletrie, 86000, Poitiers
Universitaetsklinikum Regensburg AöR
"Klinik für Urologie der Universität Regensburg am Caritas-Krankenhaus St. Josef", Landshuter Strasse 65, Kasernenviertel, Regensburg
University Hospital Cologne AöR
Klinik für Urologie, Uro-Onkologie, spezielle urologische und roboter-assistierte Chirurgie, Kerpener Strasse 62, Lindenthal, Cologne
Universitaetsklinikum Ulm AöR
Urologie und Kinderurologie, Albert-Einstein-Allee 23, Eselsberg, Ulm
Universitaetsklinikum Magdeburg AöR
Klinik für Urologie und Kinderurologie, Leipziger Strasse 44, 39120, Magdeburg
Marien Hospital Herne Universitatsklinikum Der Ruhr-Universitat Bochum
n/a, Hoelkeskampring 40, 44625, Herne
Universitaetsklinikum Wuerzburg AöR
"Klinik und Poliklinik für Urologie und Kinderurologie", Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
Universitaetsmedizin Goettingen
Urologische Klinik und Poliklinik, Robert-Koch-Strasse 40, Weende, Goettingen
Universitaetsklinikum Jena KöR
"Klinik und Poliklinik für Urologie und Kinderurologie", Am Klinikum 1, Lobeda, Jena
Universitaetsklinikum Erlangen AöR
Urologische und Kinderurologische Universitätsklinik, Rathsberger Strasse 57, Burgberg, Erlangen
Universitat Heidelberg
"Medizinische Fakultät Mannheim der Universität Heidelberg Klinik für Urologie und Urochirugie", Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
Universitaetsklinikum Muenster AöR
Klinik für Urologie und Kinderurologie, Albert-Schweitzer-Campus 1, Sentrup, Muenster
Careggi University Hospital
Dipartimento di Medicina sperimentale e clinica, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Dipartimento Corp-S di ricerca e assistenziale dei percorsi oncologici del distretto urogenitale, Via Mariano Semmola 52, 80131, Naples
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Dipartimento Malattie oncologiche ed ematologiche, Via Pietro Albertoni 15, 40138, Bologna
Fondazione IRCCS Istituto Nazionale Dei Tumori
Dipartimento di Oncologia Medica ed Ematologia, Via Giacomo Venezian 1, 20133, Milan
Istituto Tumori Bari Giovanni Paolo II
SC Oncologia Medica, Viale Orazio Flacco 65, 70124, Bari
Azienda Ospedaliera Universitaria Integrata Verona
DAI di Chirurgia e Oncologia, Piazzale Aristide Stefani 1, 37126, Verona
Ospedale San Raffaele S.r.l.
Unità di Oncologia Medica, Via Olgettina 60, 20132, Milan
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Dipartimento di Oncologia, Regione Gonzole 10, 10043, Orbassano
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Medical Oncology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Amphia Hospital
Medical Oncology, Molengracht 21, 4818 CK, Breda
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Medical Oncology, Plesmanlaan 121, 1066 CX, Amsterdam
Regionalny Szpital Specjalistyczny Im. Dr. Wladyslawa Bieganskiego
Oddzial Onkologii Klinicznej, Ul. Dr. Ludwika Rydygiera 15/17, 86-300, Grudziadz
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Nowotworow Ukladu Moczowego, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku
Oddzial Onkologii Klinicznej im. Dr Ewy Pileckiej, Ul. Ogrodowa 12, 15-027, Bialystok
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
Pododdzial Chirurgii II -Urologia, Pl. Ludwika Hirszfelda 12, 53-413, Wroclaw
Uniwersyteckie Centrum Kliniczne
Klinika Onkologii i Radioterapii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Oddzial Onkologii Klinicznej z Pododdziałem Chemioterapii Jednodniowej, Ul. Tytusa Chalubinskiego 7, 75-581, Koszalin
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie
Oddzial Kliniczny Onkologii i Immunoonkologii z Osrodkiem Dziennym Terapii Onkologicznej, Al. Wojska Polskiego 37, 10-228, Olsztyn
Mazowiecki Szpital Specjalistyczny Im.Dr.Jozefa Psarskiego W Ostrolece
Oddzial Onkologiczny, Aleja Jana Pawla II 120a, 07-410, Ostroleka
Med Polonia Sp. z o.o.
n/a, Obornicka 262, 60-693, Poznan
Complejo Hospitalario Universitario Insular Materno Infantil
Servicio de Oncologia, Autovia Del Sur S/n, 35017, Las Palmas De Gran Canaria
Hospital General Universitario Gregorio Maranon
Servicio de Oncologia, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital General Universitario Reina Sofia
Servicio de Oncologia, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Universitario 12 De Octubre
Servicio de Oncologia, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Germans Trias I Pujol
Servicio de Oncologia, Carretera Canyet 1a Planta, 08916, Badalona
Hospital Universitario Marques De Valdecilla
Servicio de Oncologia, Avenida Valdecilla Sn, 39008, Santander
Hospital Universitari Vall D Hebron
Servicio de Oncologia, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
University Hospital Virgen Del Rocio S.L.
Servicio de Oncologia, Avenida De Manuel Siurot S/n, 41013, Sevilla
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 | 2019-06-27 | 2019-07-25 | 2021-07-30 | ||
| Czechia | 2019-04-02 | 2019-04-08 | 2021-05-05 | ||
| France | 2019-04-30 | 2019-05-02 | 2021-06-30 | ||
| Germany | 2019-09-10 | 2019-11-07 | 2021-07-27 | ||
| Italy | 2019-11-15 | 2019-12-12 | 2021-07-30 | ||
| Netherlands | 2019-04-23 | 2019-05-01 | 2021-07-02 | ||
| Poland | 2019-02-11 | 2019-02-12 | 2021-07-30 | ||
| Spain | 2019-06-20 | 2019-06-20 | 2021-07-30 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 70 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Clinical study report (for publication) | d933rc00001-16-1-01-protocol-and-protocol-amendments-red | 1 |
| Clinical study report (for publication) | d933rc00001-16-1-02-sample-case-report-form-part-a-red | 1 |
| Clinical study report (for publication) | d933rc00001-16-1-02-sample-case-report-form-part-b-red | 1 |
| Clinical study report (for publication) | d933rc00001-16-1-02-sample-case-report-form-part-c-red | 1 |
| Clinical study report (for publication) | d933rc00001-16-1-09-statistical-methods-and-analysis-red | 1 |
| Clinical study report (for publication) | d933rc00001-clinical-study-report-interim-red | 1 |
| Clinical study report (for publication) | d933rc00001-csr-errata-list-red | 1 |
| Clinical study report (for publication) | d933rc00001-csr-section-narratives-part-a-red | 1 |
| Clinical study report (for publication) | d933rc00001-csr-section-narratives-part-b-red | 1 |
| Clinical study report (for publication) | d933rc00001-csr-section-narratives-part-c-red | 1 |
| Clinical study report (for publication) | d933rc00001-csr-section-narratives-part-d-red | 1 |
| Clinical study report (for publication) | d933rc00001-csr-section-narratives-part-e-red | 1 |
| Clinical study report (for publication) | d933rc00001-csr-section-tables-figures-ia1-pcr-rep-red | 1 |
| Clinical study report (for publication) | d933rc00001-csr-section-tables-figures-iemt-0215-red | 1 |
| Clinical study report (for publication) | d933rc00001-csr-section-tables-figures-iemt-red | 1 |
| Clinical study report (for publication) | d933rc00001-csr-section-tables-figures-red | 1 |
| Protocol (for publication) | D1_Protocol 2023-510015-19-00_redacted | 7 |
| Protocol (for publication) | D1_Toxicity Management Guidelines EN 2023-510015-19-00 | 2 |
| Protocol (for publication) | D1_Toxicity Management Guidelines EN 2023-510015-19-00 SOC | n/a |
| Protocol (for publication) | D1_Toxicity Management Guidelines EN 2023-510015-19-00 Tracked Changes | 21 |
| Protocol (for publication) | D1_Toxicity Management Guidelines Summary of Changes | NA |
| Protocol (for publication) | D1_Toxicity Management Guidelines Tracked Changes | NA |
| Recruitment arrangements (for publication) | CTIS Blank Document for Transition Trials | n/a |
| Recruitment arrangements (for publication) | CTIS Blank Document for Transition Trials | n/a |
| Recruitment arrangements (for publication) | CTIS Blank Document for Transition Trials | n/a |
| Recruitment arrangements (for publication) | CTIS Blank Document for Transition Trials | n/a |
| Recruitment arrangements (for publication) | CTIS Blank Document for Transition Trials | n/a |
| Recruitment arrangements (for publication) | CTIS Blank Document for Transition Trials | n/a |
| Recruitment arrangements (for publication) | CTIS Blank Document for Transition Trials | n/a |
| Recruitment arrangements (for publication) | CTIS Blank Document for Transition Trials | n/a |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Adult PL_Redacted | 7 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF pregnant partners PL | 4 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Adult Subject_Redacted_ES | 9 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Adult-Sub-study_GER_redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Pregnant Partner_ES | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF-Adult_GER_redacted | 5 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF-optional-genetic-GER_clean | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum to Informed consent form EUCTR | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adults_DP | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adults_redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main adult subject redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main NL Addendum_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main NL site 5001_redacted | 9 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main NL_redacted | 9 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_BE Dutch_redacted | 8 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_BE English_redacted | 8 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_BE French_redacted | 8 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum to ICF Handling of Personal Data | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum to ICF_Patients in FU without Progression_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Biological Samples Research Addendum to Informed Consent Form | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Genetic Research Addendum to Informed Consent Form | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Study Information and Consent Form for Adults_redacted | 7 |
| Subject information and informed consent form (for publication) | Subject Information and Informed Consent Form Placeholder | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Cisplatin | n/a |
| Summary of Product Characteristics (SmPC) (for publication) | Gemcitabine_SmPC Summary of changes | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Gemcitabine | n/a |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis Lay Language_NL Dutch | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BE Dutch_redacted | 7.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BE French_redacted | 7.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BE German_redacted | 7.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_CZ_D933RC00001_2022-502430-13-00_redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ES_Lay language | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_IT_Lay language_2023-510015-19-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_Lay Language_FR_FRA 2023-510015-19-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_lay language_PL | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_Lay Language-EN 2023-510015-19-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_redacted | 7 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_redacted | 7 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_redacted | 1 |
Application history
19 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-19 | Czechia | Acceptable 2024-02-23
|
2024-02-26 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-08 | Czechia | Acceptable 2024-06-12
|
2024-06-12 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-07-12 | Acceptable | 2024-08-26 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-07-12 | Acceptable | 2024-08-23 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-07-12 | Acceptable | 2024-07-17 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-07-12 | Acceptable | 2024-08-26 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-07-12 | Czechia | Acceptable | 2024-09-05 |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-07-12 | Acceptable | 2024-09-19 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-8 | 2024-07-12 | Acceptable | 2024-09-27 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-9 | 2024-07-12 | Acceptable | 2024-09-09 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-10 | 2024-10-26 | Czechia | Acceptable 2025-02-12
|
2025-02-13 |
| 12 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-02-28 | Acceptable | 2025-04-03 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-12 | 2025-02-28 | Acceptable | 2025-03-28 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-13 | 2025-06-03 | Czechia | Acceptable 2025-09-04
|
2025-09-05 |
| 15 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-09-09 | Czechia | Acceptable 2025-09-04
|
2025-09-09 |
| 16 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-09-11 | Acceptable 2025-09-04
|
2025-09-11 | |
| 17 | SUBSTANTIAL MODIFICATION | SM-14 | 2025-09-19 | Acceptable | 2025-10-29 | |
| 18 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-11-03 | Acceptable | 2025-11-03 | |
| 19 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-01-15 | Czechia | Acceptable | 2026-01-15 |