Overview
Sponsor-declared trial summary
Phase
Phase II and Phase III (Integrated)
Status
Ongoing, recruitment ended
Participants planned
1,000
Countries
13
Sites
46
Previously Untreated Metastatic or Unresectable Melanoma
Phase 3 portion of the trial - To compare progression-free survival (PFS) of BMS-986213 to nivolumab monotherapy in participants with previously untreated, unresectable or metastatic melanoma. Phase 2 portion of the trial - To compare PFS of BMS-986213 to nivolumab monotherapy in participants with previously untreated,…
Key facts
- Sponsor
- Bristol-Myers Squibb Services Unlimited Company
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years, 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 18 May 2018 → ongoing
- Decision date (initial)
- 2024-04-15
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Bristol-Myers Squibb International Corporation
External identifiers
- EU CT number
- 2024-510913-13-00
- EudraCT number
- 2017-003583-12
- WHO UTN
- U1111-1201-4386
- ClinicalTrials.gov
- NCT03470922
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacogenomic, Pharmacodynamic, Safety, Efficacy, Pharmacokinetic, Therapy
Phase 3 portion of the trial
- To compare progression-free survival (PFS) of BMS-986213 to nivolumab monotherapy in participants with previously untreated, unresectable or metastatic melanoma.
Phase 2 portion of the trial
- To compare PFS of BMS-986213 to nivolumab monotherapy in participants with previously untreated, unresectable or metastatic melanoma.
Secondary objectives 6
- Phase 3 portion of the trial - To compare OS of BMS-986213 to nivolumab monotherapy in subjects with previously untreated, unresectable or metastatic melanoma
- Phase 3 portion of the trial - To compare ORR of BMS-986213 to nivolumab in subjects with unresectable or metastatic melanoma
- Phase 2 portion of the trial Among subjects with unresectable or metastatic melanoma treated with BMS-986213 and those treated with nivolumab monotherapy: - To estimate the treatment effect, measured by ORR, as determined by BICR using RECISTv1.1, in subgroups based on combinations of LAG-3 expression and PDL-1 status
- Phase 2 portion of the trial Among subjects with unresectable or metastatic melanoma treated with BMS-986213 and those treated with nivolumab monotherapy: - To evaluate DOR, DCR, PFS rates at pre-specified time points based on BICR assessments using RECIST v1.1 in the randomized population and in subgroups based on combinations of LAG-3 expression and PDL-1 status
- Phase 2 portion of the trial Among subjects with unresectable or metastatic melanoma treated with BMS-986213 and those treated with nivolumab monotherapy: - To assess the 1- and 2-year landmark OS in the randomized population and in subgroups based on combinations of LAG-3 expression and PDL-1 status
- Phase 2 portion of the trial Among subjects with unresectable or metastatic melanoma treated with BMS-986213 and those treated with nivolumab monotherapy: - To assess safety and tolerability
Conditions and MedDRA coding
Previously Untreated Metastatic or Unresectable Melanoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10027481 | Metastatic melanoma | 10029104 |
| 21.1 | LLT | 10053571 | Melanoma | 10029104 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
- IPD plan description
- BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure- commitment.html
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Participants must have histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the AJCC staging system
- Participants must not have had prior systemic anticancer therapy for unresectable or metastatic melanoma
- Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses
Exclusion criteria 3
- Participants must not have active brain metastases or leptomeningeal metastases
- Participants must not have uveal melanoma
- Participants must not have an active, known, or suspected autoimmune disease
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Progression Free Survival (PFS) Phase 3 portion of trial. Assessed by a Blinded Independent Central Review (BICR)
- PFS Phase 2 portion of trial, assessed by a BICR
Secondary endpoints 11
- Phase 3 portion of trial: Overall Survival (OS)
- Phase 3 portion of trial: ORR , assessed by a BICR
- Phase 2 portion of trial: ORR , assessed by a BICR. In the randomized population and in subgroups
- Phase 2 portion of trial: Duration of Response (DOR) in the randomized population and in subgroups
- Phase 2 portion of trial: PFS in subgroups
- Phase 2 portion of trial: OS in the randomized population and in subgroups
- Phase 2 portion of the trial: Number of Adverse Events (AEs)
- Phase 2 portion of the trial: Number of Serious Adverse Events (SAEs)
- Phase 2 portion of the trial: Number of AEs Leading to Discontinuation
- Phase 2 portion of the trial: Number of Deaths
- Phase 2 portion of the trial: Number of Laboratory Abnormalities
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
- Substance synonyms
- BMS936558, ABP 206
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 480 mg milligram(s)
- Max total dose
- 9999 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
PRD9854659 · Product
- Active substance
- Nivolumab
- Pharmaceutical form
- 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
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- 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 |
|---|---|---|
| Accenture Solutions Private Limited ORG-100032592
|
Bangaluru, India | Other, Data management |
| Accenture Solutions Private Limited ORG-100032592
|
Chennai, India | Other |
| Accenture Services Pvt. Ltd. ORL-000000127
|
Bengaluru, India | Other |
| Bioclinica Inc. ORG-100033079
|
Princeton, United States | Other |
| Myriad RBM Inc. ORG-100045698
|
Austin, United States | Other |
| Accenture Services Pvt. Ltd. ORL-000000126
|
Bengaluru, India | Other, Data management |
| Mosaic Laboratories LLC ORG-100042385
|
Lake Forest, United States | Other |
| Accenture Solutions Private Limited ORG-100032592
|
Chennai, India | Other |
| Q2 Solutions ORL-000000131
|
Livingston, United Kingdom | Other |
| Icon Laboratory Services Inc. ORG-100037135
|
Farmingdale, United States | Other |
Locations
13 EU/EEA countries · 46 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 11 | 3 |
| Belgium | Ongoing, recruitment ended | 5 | 1 |
| Denmark | Ongoing, recruitment ended | 3 | 1 |
| Finland | Ongoing, recruitment ended | 29 | 4 |
| France | Ongoing, recruitment ended | 44 | 8 |
| Germany | Ongoing, recruitment ended | 64 | 11 |
| Greece | Ongoing, recruitment ended | 18 | 1 |
| Italy | Ongoing, recruitment ended | 54 | 5 |
| Norway | Ongoing, recruitment ended | 3 | 1 |
| Poland | Ongoing, recruitment ended | 38 | 3 |
| Romania | Ongoing, recruitment ended | 26 | 2 |
| Spain | Ongoing, recruitment ended | 34 | 4 |
| Sweden | Ongoing, recruitment ended | 11 | 2 |
| Rest of world
Mexico, United States, Argentina, Colombia, Israel, Taiwan, Canada, United Kingdom, Australia, Chile, Korea, Republic of, Switzerland, Japan, Russian Federation, Brazil, New Zealand
|
— | 660 | — |
Investigational sites
Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
Dermatology, Muellner Hauptstrasse 48, 5020, Salzburg
Medical University Of Graz
Dermatology and Venereology, Neue Stiftingtalstrasse 6, 8010, Graz
Medical University Of Vienna
Dermatology, Waehringer Guertel 18-20, Alsergrund, Vienna
HUS-Yhtymae
Comprehensive cancer center, Clinical Trial Unit, Haartmaninkatu 4, 00290, Helsinki
Oulu University Hospital
Department of Oncology and Radiotherapy, Oncology and hematology, Kajaanintie 50, 90220, Oulu
Turku University Hospital
Department of oncology, Clinical trial unit, Kiinamyllynkatu 4-8, 20520, Turku
Tampere University Hospital
Department of oncology, Clinical trial unit, Teiskontie 35, 33520, Tampere
Centre Hospitalier Universitaire De Poitiers
Service Oncologie Médicale, 2 Rue De La Miletrie, 86000, Poitiers
Centre Hospitalier Universitaire Amiens Picardie
Service Dermatologie, 1 Place Victor Pauchet, 80080, Amiens
Hopital Saint Louis
Polyclinique de Dermatologie, 1 Avenue Claude Vellefaux, 75010, Paris
Centre Hospitalier Universitaire De Lille
Clinique de dermatologie, Rue Michel Polonovski, 59037, Lille Cedex
Centre Hospitalier Universitaire De Bordeaux
Service de Dermatologie, 1 Rue Jean Burguet, 33000, Bordeaux
Centre Hospitalier Lyon Sud
Service Dermatologie, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Centre Hospitalier Regional De Marseille
Service Dermatologie, 264 Rue Saint Pierre, 13005, Marseille
Centre De Lutte Contre Le Cancer Eugene Marquis
Service Oncologie Médicale, Avenue La Bataille Flandre Dunkerque, Cs 44229, Rennes Cedex
Universitaetsklinikum Wuerzburg AöR
Dermatologie, Venerologie und Allergologie, Josef-Schneider-Strasse 2, Grombuehl, Wuerzburg
Universitaetsklinikum Schleswig-Holstein AöR
Dermatologie, Allergologie und Venerologie, Ratzeburger Allee 160, 23538, Luebeck
Universitaetsklinikum Tuebingen AöR
Zentrum für Dermatologie und Onkologie, Liebermeisterstrasse 25, Innenstadt, Tuebingen
Universitaetsklinikum Heidelberg AöR
NCT / Hauttumorzentrum Heidelberg, Im Neuenheimer Feld 460, Neuenheim, Heidelberg
University Hospital Cologne AöR
Dermatologie und Venerologie, Kerpener Strasse 62, Lindenthal, Cologne
Harzklinikum Dorothea Christiane Erxleben GmbH
Dermatologie und Allergologie, Ditfurter Weg 24, 06484, Quedlinburg
Elbe Kliniken Stade-Buxtehude Elbe Klinikum Buxtehude gGmbH
Dermato- Onkologie, Am Krankenhaus 1, 21614, Buxtehude
Universitat Heidelberg
Dermatologie, Venerologie und Allergologie, Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
Medizinische Hochschule Hannover
Dermatologie, Allergologie und Venerologie, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Klinikum rechts der Isar der TU Muenchen AöR
Innere Medizin III, Ismaninger Strasse 22, Au-Haidhausen, Munich
HELIOS Klinikum Erfurt GmbH
Klinik für Hautkrankheiten und Allergologie, Nordhaeuser Strasse 74, Andreasvorstadt, Erfurt
Laiko General Hospital Of Athens
1st Internal Medicine- Oncology Clinic, Sevastoupoleos 16, 115 26, Athens
Azienda Ospedaliera Universitaria Senese
Oncology, Strada Delle Scotte 14, 53100, Siena
Istituto Oncologico Veneto
Oncology, Via Gattamelata 64, 35128, Padova
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Oncology, Via Mariano Semmola 52, 80131, Naples
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Oncology, Piazza Oms 1, 24127, Bergamo
Fondazione IRCCS Istituto Nazionale Dei Tumori
Oncology, Via Giacomo Venezian 1, 20133, Milan
Uniwersytecki Szpital Kliniczny W Poznaniu
Oddział Kliniczny Onkologii Klinicznej i Doświadczalnej, Ul. Stanislawa Przybyszewskiego 49, 60-355, Poznan
Uniwersytecki Szpital Kliniczny W Poznaniu
Oddział Kliniczny Onkologii Klinicznej i Doświadczalnej, Ul. Augustyna Szamarzewskiego 84, 60-569, Poznan
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Nowotworów Tkanek Miękkich, Kości i Czerniaków, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Oncologie Medicala, Strada Republicii 34-36, 400015, Cluj-Napoca
Centrul De Oncologie SF Nectarie S.R.L.
Oncologie Medicala, Strada Caracal Nr 109, 200542, Craiova
Fundacion Onkologikoa Fundazioa
Oncology, Pasealeku Doct. Begiristain 121, 20014, Donostia
Hospital Clinic De Barcelona
Oncology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Virgen De La Macarena
Oncology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Vall D'hebron Institut De Recerca
Oncology, Passeig De La Vall D'hebron 119-129, 08035, Barcelona
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Klinisk Prövningsenhet, Verksamhetsområde Onkologi, Blå stråket 2 413 45 Göteborg, Bla Straket 5, 413 46, Goteborg
Region Skane Skanes Universitetssjukhus
Hematologimottagningen Lasarettsgatan 23A Plan 2 221 85 Lund ", Entregatan 7, 222 42, Lund
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 | 2018-06-19 | 2018-07-03 | 2020-10-21 | ||
| Belgium | 2018-06-28 | 2018-08-13 | 2020-10-21 | ||
| Denmark | 2018-09-11 | 2018-11-07 | 2020-10-21 | ||
| Finland | 2018-07-19 | 2018-09-03 | 2020-10-21 | ||
| France | 2018-06-18 | 2018-06-22 | 2020-10-21 | ||
| Germany | 2018-06-14 | 2018-06-15 | 2020-10-21 | ||
| Greece | 2024-05-24 | 2024-05-25 | 2024-05-26 | ||
| Italy | 2024-04-15 | 2024-07-13 | 2025-07-24 | ||
| Norway | 2018-09-14 | 2018-11-12 | 2020-10-21 | ||
| Poland | 2018-07-16 | 2018-07-24 | 2020-10-21 | ||
| Romania | 2019-10-09 | 2019-10-14 | 2020-10-14 | ||
| Spain | 2024-04-10 | 2024-04-10 | 2024-04-11 | ||
| Sweden | 2018-05-18 | 2018-05-24 | 2020-10-21 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 186 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1 Protocol 2024-510913-13-00 GR Redacted | 05 |
| Protocol (for publication) | D1_Protocol 2024-510913-13-00_Redacted | 05 |
| Protocol (for publication) | D1_Protocol Admin Letter 2024-510913-13-00_redacted | N/A |
| Protocol (for publication) | D1_Protocol admin Letter 2024-510913-13-00_redacted | N/A |
| Protocol (for publication) | D4_Patient facing documents_questionnaire FACT-M Subscale Source _IT | NA |
| Protocol (for publication) | D4_Patient facing documents_questionnaire FACT-M_IT | NA |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_EQ-5D-3L_Paper_IT | NA |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_EQ-5D-3L_Telephone Source doc_IT | 1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_Statement for publication_GR | N/A |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_Statement for publication_IT | NA |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_WPAI-GH_IT | NA |
| Protocol (for publication) | D4_Patient facing documents_Statement for Questionnaires_BE | 1 |
| Protocol (for publication) | D4_Patient facing documents_Statement for Questionnaires_FR | 1 |
| Protocol (for publication) | D4_Patient facing documents_Statement for Questionnaires_PL | N/A |
| Protocol (for publication) | D4_Statement on validated questionnaires under licence_AT | N/A |
| Protocol (for publication) | D4_Statement on validated questionnaires under licence_DE | 1 |
| Protocol (for publication) | D4_Statement on validated questionnaires under licence_Eng | 1 |
| Protocol (for publication) | D4_Statement on validated questionnaires under licence_ES | 1 |
| Protocol (for publication) | D4_Statement on validated questionnaires under licence_RO | NA |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_SE | 1 |
| Recruitment arrangements (for publication) | K_Recruitment arrangement_Blank Statement | 1 |
| Recruitment arrangements (for publication) | K1 Recruitment Arrangement statement | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent Procedures Form_blank statement_ES | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent Procedures Form_blank statement_PL | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent Procedures Form_blank statement_RO | NA |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent Procedures Form_statement_FR | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement_blank statement_DE | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements statement | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_AT | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_blank document_GR | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_blank statement | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_blank statement_BE | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangment_IT | 2 |
| Subject information and informed consent form (for publication) | L!-SIS and ICF Addendum Pregnant Partner V1_ES_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1 CA224-047 DK_ICF Addendum continue to participate ICF v1 21May2025_dan | 1 |
| Subject information and informed consent form (for publication) | L1_CA224-047 ICF Add Research_Al | 4 |
| Subject information and informed consent form (for publication) | L1_CA224-047 ICF Add Research_Redacted_ IT | 4 |
| Subject information and informed consent form (for publication) | L1_CA224-047 ICF Main IT Redacted | 14 |
| Subject information and informed consent form (for publication) | L1_CA224-047 ICF Main_Al | 11 |
| Subject information and informed consent form (for publication) | L1_CA224-047 ICF Optional research_ IT | 2 |
| Subject information and informed consent form (for publication) | L1_CA224-047 ICF Optional research_Al | 2 |
| Subject information and informed consent form (for publication) | L1_CA224-047 ICF Pregnancy Partner_Redacted_ IT | 4 |
| Subject information and informed consent form (for publication) | L1_CA224-047 ICF Treatment beyond Progression IT | 2 |
| Subject information and informed consent form (for publication) | L1_ICF Add V1_to Main V2_DE_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Add V1_to Main V3_AT_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Add V10_to Main V8_DE_Redacted | 10 |
| Subject information and informed consent form (for publication) | L1_ICF Add V10_to Main V9_AT_redacted | 10 |
| Subject information and informed consent form (for publication) | L1_ICF Add V11_to Main V8_DE_Redacted | 11 |
| Subject information and informed consent form (for publication) | L1_ICF Add V11_to Main V9_AT_redacted | 11 |
| Subject information and informed consent form (for publication) | L1_ICF Add V12_to Main V8_DE_redacted | 12 |
| Subject information and informed consent form (for publication) | L1_ICF Add V12_to Main V9_AT_redacted | 12 |
| Subject information and informed consent form (for publication) | L1_ICF Add V2_to Main V5_DE_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_ICF Add V2_to Main V6_AT_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_ICF Add V3_to Main V6_DE_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_ICF Add V3_to Main V7_AT_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_ICF Add V4_to Main V7_DE_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_ICF Add V4_to Main V8_AT_redacted | 4 |
| Subject information and informed consent form (for publication) | L1_ICF Add V5_to Main V8_DE_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1_ICF Add V5_to Main V9_AT_redacted | 5 |
| Subject information and informed consent form (for publication) | L1_ICF Add V6_to Main V8_DE_Redacted | 6 |
| Subject information and informed consent form (for publication) | L1_ICF Add V6_to Main V9_AT_redacted | 6 |
| Subject information and informed consent form (for publication) | L1_ICF Add V7_to Main V8_DE_Redacted | 7 |
| Subject information and informed consent form (for publication) | L1_ICF Add V7_to Main V9_AT_redacted | 7 |
| Subject information and informed consent form (for publication) | L1_ICF Add V8_to Main V8_DE_Redacted | 8 |
| Subject information and informed consent form (for publication) | L1_ICF Add V8_to Main V9_AT_redacted | 8 |
| Subject information and informed consent form (for publication) | L1_ICF Add V9_to Main V8_DE_Redacted | 9 |
| Subject information and informed consent form (for publication) | L1_ICF Add V9_to Main V9_AT_redacted | 9 |
| Subject information and informed consent form (for publication) | L1_ICF AR_GER_CL_DE | 2 |
| Subject information and informed consent form (for publication) | L1_ICF Main_GER_Global_V10_DE_Redacted | 8 |
| Subject information and informed consent form (for publication) | L1_ICF Main_Global V10_AT_Redacted | 9 |
| Subject information and informed consent form (for publication) | L1_ICF Optional Tumor Biopsy day29_GER_Global V2_DE | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Optional Tumor Biopsy upon Progression_CL_AT | 2 |
| Subject information and informed consent form (for publication) | L1_ICF Optional Tumor Biopsy upon Progression_GER_Global V2_CL_DE | 2 |
| Subject information and informed consent form (for publication) | L1_ICF PP_GER_Global_V4_CL_DE | 2 |
| Subject information and informed consent form (for publication) | L1_ICF TBP_CL_AT | 2 |
| Subject information and informed consent form (for publication) | L1_ICF TBP_GER_Global V1_CL_DE | 2 |
| Subject information and informed consent form (for publication) | L1_Optional Tumor Biopsy day29_AT | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum 06_FR_redacted | 06 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum 07_FR_redacted | 07 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum 08_FR_redacted | 08 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum 09_FR_redacted | 09 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum 1 to ICF V4_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum 10_FR_redacted | 10 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum 11_FR_redacted | 11 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum 2 to ICF V4_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum Future Research | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum Main | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum Main_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum Optional Biopsy_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum Optional Biopsy_V1_ES_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum Progressive Disease | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum Progressive Disease V1_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum_FR_redacted | 13 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum_Redacted | 15.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum_Redacted | 13 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum_TC | 16 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum_v10_Redacted | 10 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum_v11_ES_Redacted | 11 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF addendum_V11_Redacted | 11 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum_v12_Redacted | 12 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum_v6_Redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum_v7_Redacted | 7 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum_V8_Redacted | 8 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum_v9_Redacted | 9 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Additional Note 01_FR_redacted | 01 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Additional Note 02_FR_redacted | 02 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Additional Note 03_FR_redacted | 03 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Additional Note 04_FR_redacted | 04 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Additional Note 05_FR_redacted | 05 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Additional Note 06_FR_redacted | 06 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Appendix A to Main ICF Side effect_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for Optional Genetic Research_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for Pregnant Partners | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for travel reimbursement_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for Treatment beyond Progression | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_adult_FR_redacted | 06 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_assent_FR | 03 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Clean_Redacted | 8 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_parents_FR_redacted | 06 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 13 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 8 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_V5_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional 01_adult_FR | 01 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional 01_parents_FR | 01 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional 02_adult_FR | 02 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional 02_parents_FR | 02 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional 02_v2_FR | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional 03_adult_FR_redacted | 03 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional 03_parents_FR_redacted | 03 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional 03_v2_FR_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Biopsy | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional biopsy_Not to be redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Tumor Biopsy_No redactions needed | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Subject leaflet_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment after progression_Not to be 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_SIS and ICF Treatment Beyond Progression_No redactions needed | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF V10_ES_Redacted | 10 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum 14_FR_redacted | 14 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum to Main IC_BE_eng_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum to Main IC_BE_fra_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum to Main IC_v2_11Apr19_BE_nld_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum_Optional Biopsy_PL | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum_Reimbursement_PL | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum_Treatment Beyond Progression_PL | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Data Privacy_PL | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main adult_parent_BE_eng_redacted | 7 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main adult_parent_BE_fra_redacted | 7 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main adult_parent_BE_nld_redacted | 7 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_PL_Redacted | 16 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Biopsy_BE_eng_no redaction | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Biopsy_BE_fra_no redaction | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Biopsy_BE_nld_no redaction | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_BE_eng_no redaction | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_BE_fra_no redaction | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_BE_nld_no redaction | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment Beyond Progression_BE_eng_no redaction | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment Beyond Progression_BE_fra_no redaction | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment Beyond Progression_BE_nld_no redaction | 1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Future Research Addendum_No redaction | 1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Main_Redacted | 8 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Optional Tumor Biopsy_No redactions | 1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Pregnant Partner_No redactions | 1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Treatment Beyond Progression_No redaction | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ Additional Note 01_BE-en | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Additional Note 01_BE-fr | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Additional Note 01_BE-nl | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Additional Note 07_FR | 07 |
| Subject information and informed consent form (for publication) | L2_Site contact details_AT_Redacted | 7 |
| Synopsis of the protocol (for publication) | D1 Protocol Synopsis GR 2024-510913-13-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis EU CT 2024-510913-13-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ 2024-510913-13-00_IT | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ 2024-510913-13-00_PL | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-510913-13-00_BE_DE | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-510913-13-00_BE_FR | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-510913-13-00_BE_NL | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-510913-13-00_ES | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-510913-13-00_FR | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-510913-13-00_SE | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_AT_EU CT 2024-510913-13 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG_2023-509360-24-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_RO_EU CT 2024-510913-13 | 1 |
Application history
22 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-12 | Finland | Acceptable 2024-04-10
|
2024-04-10 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-06-11 | Finland | Acceptable 2024-04-10
|
2024-06-11 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-20 | Acceptable | 2024-08-28 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-06-21 | Acceptable | 2024-08-05 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-06-24 | Acceptable | 2024-07-30 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-06-25 | Acceptable | 2024-07-11 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-06-26 | Acceptable | 2024-08-09 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-07-04 | Acceptable | 2024-08-06 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-10 | 2024-07-05 | Acceptable | 2024-08-02 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-11 | 2024-07-05 | Acceptable | 2024-09-06 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-07-10 | Acceptable | 2024-08-20 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-8 | 2024-07-12 | Finland | Acceptable | 2024-08-12 |
| 13 | SUBSTANTIAL MODIFICATION | SM-9 | 2024-07-19 | Acceptable | 2024-10-18 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-12 | 2024-08-08 | Acceptable | 2024-11-18 | |
| 15 | SUBSTANTIAL MODIFICATION | SM-13 | 2024-08-12 | Acceptable | 2024-08-13 | |
| 16 | SUBSTANTIAL MODIFICATION | SM-14 | 2024-12-10 | Finland | Acceptable 2025-03-03
|
2025-03-03 |
| 17 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-03-27 | Finland | Acceptable 2025-03-03
|
2025-03-27 |
| 18 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-04-07 | Acceptable 2025-03-03
|
2025-04-07 | |
| 19 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-04-16 | Acceptable 2025-03-03
|
2025-04-16 | |
| 20 | SUBSTANTIAL MODIFICATION | SM-15 | 2025-06-12 | Finland | Acceptable 2025-08-13
|
2025-08-13 |
| 21 | SUBSTANTIAL MODIFICATION | SM-16 | 2025-09-17 | Finland | Acceptable 2025-10-01
|
2025-10-01 |
| 22 | SUBSTANTIAL MODIFICATION | SM-17 | 2025-11-17 | Finland | Acceptable 2026-03-03
|
2026-03-03 |