Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
1,777
Countries
11
Sites
41
Untreated Unresectable or Metastatic Urothelial Cancer
Main Study: -To compare Overall Survival (OS) of nivolumab combined with ipilimumab versus standard of care (SOC) chemotherapy in cisplatin-ineligible participants with previously untreated, unresectable or metastatic urothelial carcinoma (UC). -To compare OS of nivolumab combined with ipilimumab versus standard of ca…
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
- 26 May 2017 → 9 Jul 2025
- Decision date (initial)
- 2024-03-11
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2022-501784-40-00
- EudraCT number
- 2016-003881-14
- WHO UTN
- U1111-1187-9637
- ClinicalTrials.gov
- NCT03036098
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Pharmacodynamic, Therapy, Efficacy, Safety, Pharmacogenomic
Main Study:
-To compare Overall Survival (OS) of nivolumab combined with ipilimumab versus standard of care (SOC) chemotherapy in cisplatin-ineligible participants with previously untreated, unresectable or metastatic urothelial carcinoma (UC).
-To compare OS of nivolumab combined with ipilimumab versus standard of care (SOC) chemotherapy in PD-L1 positive (>= 1%) participants with previously untreated, unresectable or metastatic UC.
Secondary objectives 3
- To compare OS of nivolumab combined with ipilimumab versus SOC chemotherapy in all randomized participants with previously untreated, unresectable or metastatic UC.
- To evaluate Progression-Free Survival (PFS) of nivolumab combined with ipilimumab versus SOC chemotherapy in cisplatin-ineligible randomized participants, in PD-L1 positive (>= 1%) randomized participants and in all randomized participants with previously untreated, unresectable or metastatic UC.
- To evaluate changes from baseline in Health-Related QOL (HRQoL) of nivolumab combined with ipilimumab versus SOC chemotherapy in all randomized participants with previously untreated, unresectable or metastatic UC.
Conditions and MedDRA coding
Untreated Unresectable or Metastatic Urothelial Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10064467 | Urothelial carcinoma | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Metastatic or inoperable urothelial cancer
- Must have at least 1 lesion with measurable disease
- Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
- No prior systemic chemotherapy treatment in the metastatic setting
Exclusion criteria 6
- Patients with ECOG PS >= 2
- Patients with disease that is suitable for local therapy administered with curative intent
- Patients with active brain metastases or leptomeningeal metastases
- Patients with active, known or suspected autoimmune disease
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
- Participants may not have received live/attenuated vaccines within 30 days prior to first study treatment.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Primary endpoint of OS in cisplatin-ineligible randomized participants
- Primary endpoint of OS in PD-L1 positive (>= 1%) randomized participants by immunohistochemistry (IHC)
Secondary endpoints 3
- OS in all randomized participants
- PFS by blinded independent central review (BICR) (using RECIST 1.1) in cisplatin-ineligible randomized participants, in PD-L1 positive (>=1%) randomized participants and in all randomized participants
- European Organisation for Research and Treatment of Care (EORTC) QLQ-C30 Global Health Status score in all randomized participants
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
OPDIVO 10 mg/mL concentrate for solution for infusion.
PRD2941375 · Product
- Active substance
- Nivolumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 480 mg milligram(s)
- Max total dose
- 4080 mg milligram(s)
- Max treatment duration
- 9999 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF01 — -
- Marketing authorisation
- EU/1/15/1014/002
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
YERVOY 5 mg/ml concentrate for solution for infusion
PRD363872 · Product
- Active substance
- Ipilimumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 3 mg/Kg milligram(s)/kilogram
- Max total dose
- 12 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 84 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01FX04 — -
- Marketing authorisation
- EU/1/11/698/002
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Clinical Supplies will be labelled and packaged for the use of the study, commercial supplies will not be used
Comparator 9
GEMCI-cell® 38 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD1952673 · Product
- Active substance
- Gemcitabine
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 1000 mg/m2 milligram(s)/sq. meter
- Max total dose
- 12000 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 126 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BC05 — GEMCITABINE
- Marketing authorisation
- 73750.00.00
- MA holder
- STADAPHARM GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- clinical label for the purpose of this trial
Gemcitabine 1 g Powder for Solution for Infusion
PRD391098 · Product
- Active substance
- Gemcitabine
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 1000 mg/m2 milligram(s)/sq. meter
- Max total dose
- 12000 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 126 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BC05 — GEMCITABINE
- Marketing authorisation
- PL 20075/0026
- MA holder
- ACCORD HEALTHCARE LIMITED
- MA country
- United Kingdom
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- clinical label for the purpose of this trial
Gemcitabine 38 mg/ml Concentrate for Solution for Infusion
PRD6624336 · Product
- Active substance
- Gemcitabine
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 1000 mg/m2 milligram(s)/square meter
- Max total dose
- 12000 mg/m2 milligram(s)/square meter
- Max treatment duration
- 126 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BC05 — GEMCITABINE
- Marketing authorisation
- PL 04515/0224
- MA holder
- HOSPIRA UK LTD
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- clinical label for the purpose of this trial
Carbomedac® 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD536350 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 5 Other
- Max total dose
- 5 Other
- Max treatment duration
- 126 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 39079.02.00
- 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
- clinical label for the purpose of this trial
Carboplatin Bendalis 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD2832939 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 5 Other
- Max total dose
- 5 Other
- Max treatment duration
- 126 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 86830.00.00
- MA holder
- BENDALIS GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- clinical label for the purpose of this trial
CARBO-cell® 10 mg/ml Infusionslösung, Konzentrat zur Herstellung einer Infusionslösung
PRD1969079 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 5 Other
- Max total dose
- 5 Other
- Max treatment duration
- 126 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 46297.00.00
- MA holder
- STADAPHARM GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- clinical label for the purpose of this trial
Cisplatin NeoCorp 1 mg/ml - Konzentrat zur Herstellung einer Infusionslösung
PRD759858 · Product
- Active substance
- Cisplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 70 mg/m2 milligram(s)/square meter
- Max total dose
- 420 mg/m2 milligram(s)/square meter
- Max treatment duration
- 126 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- 39021.01.00
- MA holder
- HEXAL AG
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- clinical label for the purpose of this trial
Cisplatin-Ebewe, 1 Mg/Ml, Koncentrat Do Sporządzania Roztworu Do Infuzji
PRD771236 · Product
- Active substance
- Cisplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 70 mg/m2 milligram(s)/square meter
- Max total dose
- 420 mg/m2 milligram(s)/square meter
- Max treatment duration
- 126 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- 19903
- MA holder
- EBEWE PHARMA
- MA country
- Poland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- clinical label for the purpose of this trial
Cisplatin Teva® 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD662245 · Product
- Active substance
- Cisplatin
- Pharmaceutical form
- INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 70 mg/m2 milligram(s)/sq. meter
- Max total dose
- 420 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 126 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- 71983.00.00
- MA holder
- TEVA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- clinical label for the purpose of this trial
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 International Corporation
- Contact name
- GSM-CT
Public contact point
- Organisation
- Bristol Myers Squibb International Corporation
- Contact name
- GSM-CT
Third parties 11
| Organisation | City, country | Duties |
|---|---|---|
| PPD Development LP ORG-100011560
|
Richmond, United States | Other |
| Myriad RBM Inc. ORG-100045698
|
Austin, United States | Other |
| Bioclinica Inc. ORG-100033079
|
Princeton, United States | Other |
| Mosaic Laboratories LLC ORG-100042385
|
Lake Forest, United States | Other |
| Accenture Solutions Private Limited ORG-100032592
|
Chennai, India | Other, Data management |
| Cellcarta Fremont LLC ORG-100042774
|
Fremont, United States | Other |
| Accenture Solutions Private Limited ORG-100032592
|
Bangaluru, India | Other, Data management |
| Icon (Lr) Limited ORG-100042612
|
Dublin 18, Ireland | Other |
| Icon Laboratories Inc. ORG-100037135
|
Farmingdale, United States | Other |
| Accenture Solutions Private Limited ORG-100032592
|
Chennai, India | Data management |
| PAREXEL INTERNATIONAL (IRL) Limited ORG-100022780
|
Dublin 2, Ireland | Other, Interactive response technologies (IRT) |
Locations
11 EU/EEA countries · 41 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ended | 20 | 2 |
| Denmark | Ended | 13 | 2 |
| France | Ended | 144 | 7 |
| Germany | Ended | 92 | 8 |
| Greece | Ended | 70 | 2 |
| Italy | Ended | 89 | 6 |
| Netherlands | Ended | 70 | 3 |
| Norway | Ended | 8 | 1 |
| Poland | Ended | 35 | 1 |
| Romania | Ended | 75 | 2 |
| Spain | Ended | 85 | 7 |
| Rest of world
Canada, United States, Taiwan, Japan, Korea, Republic of, Australia, Brazil, Peru, Switzerland, China, Argentina, Chile, South Africa
|
— | 1,076 | — |
Investigational sites
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, 500 03, Novy Hradec Kralove
Aalborg University Hospital
Oncology, Hobrovej 18/22, 9000, Aalborg
Herlev Hospital
Oncology, Borgmester Ib Juuls Vej 1, 2730, Herlev
Centre Hospitalier Universitaire De Saint Etienne
Oncology, Avenue Albert Raimond, 42270, Saint Priest En Jarez
Institut Gustave Roussy
Medical Oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut Paoli-Calmettes
Medical Oncology, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Centre Hospitalier Universitaire De Nimes
Medical Oncology, 4 Place Du Professeur Robert Debre, Bp 40026, Nimes Cedex 9
Hospital Foch
Medical Oncology, 40 Rue Worth, 92150, Suresnes
Centre Hospitalier Regional Universitaire De Tours
Oncology, 2 Boulevard Tonnelle, 37044, Tours Cedex 9
Centre Oscar Lambret
Urological and Digestive Oncology, 3 Rue Frederic Combemale, 59000, Lille
Universitaetsklinikum Jena KöR
Studienbuero Urologie, Am Klinikum 1, Lobeda, Jena
Universitaetsklinikum Tuebingen AöR
Universitaetsklinik fuer Urologie, Hoppe-Seyler-Strasse 3, Nordstadt, Tuebingen
Universitaetsklinikum Wuerzburg AöR
Interdisziplinäres Studienzentrum (ISZ) mit ECTU (Haus C16), Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
Universitat Heidelberg
Urologische Klinik, Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
Medical Center - University Of Freiburg
Klinik f. Innere Medizin I, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
Medizinische Hochschule Hannover
Klinik f Urologie und Urologische Onkologie, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Klinikum Nuernberg
Medizinische Klinik 5, Prof.-Ernst-Nathan-Strasse 1, St. Johannis, Nuremberg
Asklepios Kliniken Hamburg GmbH
Klinik f. Urologie, Paul-Ehrlich-Strasse 1, Othmarschen, Hamburg
Alexandra Hospital
Department of Clinical Therapeutics, Vassilissas Sofias Avenue 80, 115 28, Athens
University General Hospital Of Ioannina
Oncology Clinic, Niarchou Stavrou Avenue, 455 00, Ioannina
Fondazione IRCCS Istituto Nazionale Dei Tumori
Oncologia medica genitourinaria, Via Giacomo Venezian 1, 20133, Milan
Azienda Unita Sanitaria Locale Della Romagna
U.O di Oncologia, Viale Vincenzo Randi 5, 48121, Ravenna
Azienda Unita Sanitaria Locale Della Romagna
U.O di Oncologia, Viale Dante 10, 48022, Lugo
Azienda USL Toscana Sud Est
U.O.C Oncologia Medica 1, Ospedale Area Aretina Nord, Via Pietro Nenni 20/22, Arezzo
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Oncologia Medica, Via Piero Maroncelli 40, 47014, Meldola
Azienda Unita Sanitaria Locale Della Romagna
U.O di Oncologia, Viale Stradone 9, 48018, Faenza
Medisch Centrum Leeuwarden B.V.
Medische Oncologie, Henri Dunantweg 2, 8934 AD, Leeuwarden
Universitair Medisch Centrum Groningen
Medische Oncologie, P. O. Box 30001, 9700 RB, Groningen
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Medische Oncologie, Plesmanlaan 121, 1066 CX, Amsterdam
Akershus University Hospital
Department of Oncology, Sykehusveien 25, 1474, Loerenskog
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Oddział Dzienny Chemioterapii, Ul. Tytusa Chalubinskiego 7, 75-581, Koszalin
Centrul De Oncologie SF Nectarie S.R.L.
Oncology, Strada Caracal Nr 109, 200542, Craiova
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Oncology, Strada Republicii 34-36, 400015, Cluj-Napoca
Hospital De La Santa Creu I Sant Pau
Genitourinari Oncologia Medica, Carrer De San Quinti 89, 08041, Barcelona
Hospital Universitario Marques De Valdecilla
Oncologia Medica, Avenida Valdecilla Sn, 39008, Santander
University Hospital Virgen Del Rocio S.L.
Oncologia Medica, Avenida De Manuel Siurot S/n, 41013, Sevilla
Complejo Hospitalario Universitario Juan Canalejo
Oncologia, Barrio As Xubias 84, 15006, A Coruna
Fundacion Instituto Valenciano De Oncologia
Unidad Investigacion Clinica, Calle Professor Beltran Baguena 8, 46009, Valencia
Hospital Universitario Ramon Y Cajal
Oncologia, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario 12 De Octubre
Oncologia, Bloque D, Avenida De Cordoba Sn, Madrid
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 |
|---|---|---|---|---|---|
| Czechia | 2018-03-05 | 2025-05-19 | 2018-06-20 | 2022-08-30 | |
| Denmark | 2018-06-01 | 2025-05-12 | 2018-09-14 | 2022-08-30 | |
| France | 2017-10-12 | 2025-10-02 | 2017-10-24 | 2021-11-17 | |
| Germany | 2017-06-23 | 2025-06-20 | 2017-06-30 | 2022-08-15 | |
| Greece | 2024-04-23 | 2025-10-23 | 2024-04-24 | 2024-04-25 | |
| Italy | 2017-10-19 | 2025-06-19 | 2017-10-26 | 2022-08-29 | |
| Netherlands | 2017-05-26 | 2025-06-13 | 2017-05-29 | 2022-08-30 | |
| Norway | 2018-05-29 | 2025-06-04 | 2018-07-06 | 2022-08-30 | |
| Poland | 2018-06-11 | 2025-02-06 | 2018-06-28 | 2019-09-17 | |
| Romania | 2019-02-25 | 2025-07-09 | 2019-02-28 | 2022-05-31 | |
| Spain | 2017-07-04 | 2025-06-20 | 2017-07-10 | 2022-08-30 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 76 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Clinical study report (for publication) | CSR_app-8-1-thru-11-1-4-CSR_EU CT 2022-501784-40-00_Part1 | 1 |
| Clinical study report (for publication) | CSR_app-8-1-thru-11-1-4-CSR_EU CT 2022-501784-40-00_Part2 | 1 |
| Clinical study report (for publication) | CSR_app-8-1-thru-11-1-4-CSR_EU CT 2022-501784-40-00_Part3 | 1 |
| Clinical study report (for publication) | CSR_app-8-1-thru-11-1-4-CSR_EU CT 2022-501784-40-00_Part4 | 1 |
| Clinical study report (for publication) | CSR_app-8-1-thru-11-1-4-CSR_EU CT 2022-501784-40-00_Part5 | 1 |
| Clinical study report (for publication) | CSR_app-8-1-thru-11-1-4-CSR_EU CT 2022-501784-40-00_Part6 | 1 |
| Clinical study report (for publication) | CSR_app-8-1-thru-11-1-4-CSR_EU CT 2022-501784-40-00_Part7 | 1 |
| Clinical study report (for publication) | CSR_Substudy-fa-csr-study-information EU CT 2022-501784-40-00 | 1 |
| Clinical study report (for publication) | CSR_Substudy-fa-csr-supplemental-figures_EU CT 2022-501784-40-00 | 1 |
| Clinical study report (for publication) | CSR_Substudy-fa-csr-tp-synopsis-body_EU CT 2022-501784-40-00 | 1 |
| Clinical study report (for publication) | CSR-Substudy-fa-csr-data-app-2-2-4-thru-7-7-_EU CT 2022-501784-40-00 | 1 |
| Clinical study report (for publication) | CSR-substudy-fa-csr-safety-narratives_EU CT 2022-501784-40-00 | 1 |
| Clinical study report (for publication) | CSR-substudy-fa-csr-supplemental-tables_EU CT 2022-501784-40-00 | 1 |
| Protocol (for publication) | D1_Protocol 2022-501784-40 GR Redacted | PA01-EU |
| Protocol (for publication) | D1_Protocol Admin Letter 19_2022-501784-40-00_redacted | n/a |
| Protocol (for publication) | D1_Protocol Admin Letter_2022-501784-40-00_redacted | 21 |
| Protocol (for publication) | D1_Protocol_2022-501784-40-00_Redacted | PA01EU |
| Recruitment arrangements (for publication) | K Statement for Recruitment Arrangements_PL | 1 |
| Recruitment arrangements (for publication) | K1_NL_Blank document_Recruitment arrangements | NA |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent Procedures Form_blank statement_fr | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent Procedures Form_blank statement_IT | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_blank document_CZ | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_blank document_ES | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_blank document_GR | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Connect Leaflet_CZ | NA |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Addendum | 04 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF for Optional Genetic | 6.0 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF for Pregnant partners | 4.0 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF for Treatment Beyond Progression Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF main Redacted | 11.0 |
| Subject information and informed consent form (for publication) | L1_NL_Future Research ICF_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_NL_Main ICF_Redacted | 17.1 |
| Subject information and informed consent form (for publication) | L1_NL_Optional Tumor Biopsy ICF_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_NL_Treatment beyond progression ICF_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Add costs reimbursement_PL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum 1.0_CZ_public | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum 10_FR_ForPub | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum 10.0_CZ_public | 10.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum 2.0_CZ_public | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum 3.0_CZ_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum 4.0_CZ_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum 5.0_CZ_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum 6.0_CZ_redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum 7.0_CZ_public | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum 8.1_CZ_redacted | 8.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum 9_FR_ForPub | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum 9.0_CZ_public | 9.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum Optional Research_IT_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum TBP_IT_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum_IT_Redacted | 8 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Data Privacy_PL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main Addendum1_PL_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main Addendum2_PL_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main Addendum3_PL_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main Addendum4_PL_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_FR_ForPub | 9 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_IT_Redacted | 10 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main_PL_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional 3_FR_ForPub | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Tumor Biopsy_PL_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy_IT_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment Beyond Progression_PL_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Additional ICF_CZ_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adendum 10_8Sep2022_Redacted | 10 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_CZ_redacted | 11.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_v15_8Sep2022_Redacted | 15 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional 1_FR_ForPub | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional 2_FR_ForPub | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional ICF1_CZ_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional ICF2_CZ_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional ICF3_CZ_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment Beyond Progression_v2_9May2017_redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CN_CZ_redacted | 4.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Carboplatin | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Cisplatin | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Gemcitabine | n/a |
Application history
13 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-01 | Denmark | Acceptable 2024-03-08
|
2024-03-08 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-06-01 | Acceptable 2024-03-08
|
2024-06-01 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-02 | Denmark | Acceptable 2024-10-04
|
2024-10-04 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-11-21 | Denmark | Acceptable 2025-01-17
|
2025-01-17 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-03-06 | Acceptable 2025-01-17
|
2025-03-06 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-03-12 | Acceptable | 2025-05-12 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-03-13 | Acceptable | 2025-03-19 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-06-30 | Acceptable | 2025-06-30 | |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-06-30 | Acceptable | 2025-06-30 | |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-07-28 | Acceptable | 2025-07-28 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-10-17 | Acceptable 2026-01-26
|
2026-01-26 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-03-02 | Acceptable 2026-03-16
|
2026-03-23 | |
| 13 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2026-05-29 | Denmark | Acceptable 2026-03-16
|
2026-05-29 |