Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
448
Countries
8
Sites
44
Advanced Renal Cell Carcinoma with Intermediate- or Poor-Risk Factors
- To compare the PFS using RECIST 1.1 of nivolumab combined with ipilimumab and nivolumab and placebo in all randomized participants - To compare the ORR using RECIST 1.1 of nivolumab combined with ipilimumab and nivolumab and placebo in all randomized participants
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
- 11 Jun 2019 → ongoing
- Decision date (initial)
- 2024-03-14
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-508264-29-00
- EudraCT number
- 2018-004695-35
- WHO UTN
- U1111-1225-2065
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Pharmacokinetic, Efficacy, Pharmacoeconomic, Pharmacodynamic, Pharmacogenomic, Others, Pharmacogenetic, Safety
- To compare the PFS using RECIST 1.1 of nivolumab combined with ipilimumab and nivolumab and placebo in all randomized participants
- To compare the ORR using RECIST 1.1 of nivolumab combined with ipilimumab and nivolumab and placebo in all randomized participants
Secondary objectives 5
- To compare the OS of nivolumab combined with ipilimumab and nivolumab and placebo in all randomized participants
- To evaluate additional efficacy measures in all randomized participants.
- To estimate the incidence of AEs of nivolumab combined with ipilimumab and nivolumab and placebo in all treated participants
- To investigate whether gene expression (GEP) signatures related to clear cell RCC (ccRCC) enrich for clinical benefit with nivolumab combined with ipilimumab and nivolumab and placebo in all randomized participants
- To explore association of baseline PD-L1 expression on tumor with clinical benefit
Conditions and MedDRA coding
Advanced Renal Cell Carcinoma with Intermediate- or Poor-Risk Factors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10067946 | Renal cell carcinoma | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Histological confirmation of renal carcinoma with clear cell component including participants who may have sarcomatoid features.
- Advanced (not amenable to curative surgery or radiation therapy) renal cell carcinoma (RCC) or metastatic RCC (mRCC).
- Measurable disease by CT or MRI per RECIST 1.1 criteria.
- No prior systemic therapy for RCC
- Must be intermediate or poor risk as per International Metastatic RCC Database Consortium (IMDC).
Exclusion criteria 3
- Any active central nervous system (CNS) metastases.
- Active, known, or suspected autoimmune disease
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti CTLA-4 antibody, or any other agents specifically targeting T-cell co stimulation or checkpoint pathways
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Progression free survival (PFS) by BICR
- Overall Response Rate (ORR) by BICR
Secondary endpoints 11
- Overall survival (OS)
- Overall response rate (ORR) by Investigator
- Disease control rate (DCR) by Investigator and by blinded independent central review (BICR)
- Duration of response (DoR) by Investigator and by blinded independent central review (BICR)
- Time to objective response (TTR) by Investigator and by blinded independent central review (BICR)
- Progression free survival (PFS) and PFS2 per Investigator
- Incidence of adverse events (AEs), Serious Adverse Events, drug - related SAEs and significant changes in laboratory tests (Hematology tests, Coagulation tests), Clinical Chemistry Tests and Serology Tests)
- PFS, ORR and OS based on GEP signatures
- Overall Survival based on programmed cell death protein ligand-1 (PD-L1) expression
- Overall response rate (ORR) by BICR based on PD-L1 expression
- Progression Free Survival (PFS) by BICR based on PD-L1 expression)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD191358 · Product
- Active substance
- Ipilimumab
- Other product name
- MDX-010
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 1 mg/kg milligram(s)/kilogram
- Max total dose
- 4 mg/kg milligram(s)/kilogram
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
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
- 12480 mg milligram(s)
- Max treatment duration
- 104 Week(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
Placebo 2
Sodium chloride 0.9%, solution for infusion
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
5% Dextrose, solution for infusion
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
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 7
| Organisation | City, country | Duties |
|---|---|---|
| Signant Health Global LLC ORG-100040604
|
San Francisco, United States | Other |
| Accenture Solutions Private Limited ORG-100032592
|
Chennai, India | Other |
| Accenture Solutions Private Limited ORG-100032592
|
Chennai, India | Data management |
| Accenture Solutions Private Limited ORG-100032592
|
Bangaluru, India | Other |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Icon Laboratory Services Inc. ORG-100037135
|
Farmingdale, United States | Other |
| Accenture Solutions Private Limited ORG-100032592
|
Bangaluru, India | Other, Data management |
Locations
8 EU/EEA countries · 44 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 13 | 2 |
| Czechia | Ongoing, recruitment ended | 21 | 3 |
| France | Ongoing, recruitment ended | 83 | 15 |
| Greece | Ongoing, recruitment ended | 5 | 2 |
| Italy | Ongoing, recruitment ended | 11 | 4 |
| Poland | Ongoing, recruitment ended | 60 | 5 |
| Romania | Ongoing, recruitment ended | 11 | 3 |
| Spain | Ongoing, recruitment ended | 50 | 10 |
| Rest of world
Chile, Argentina, Mexico
|
— | 194 | — |
Investigational sites
Medical University Of Graz
University clinic for Internal Medicine (UKIM), Neue Stiftingtalstrasse 6, 8010, Graz
Medical University of Vienna
Internal Medicine I - Department for Oncology, Waehringer Guertel 18-20, Alsergrund, Vienna
Masarykuv Onkologicky Ustav
Klinika komplexni onkologicke pece, Zluty Kopec 543/7, Stare Brno, Brno-Stred
Fakultni Nemocnice Kralovske Vinohrady
Onkologicka klinika, Srobarova 1150/50, Vinohrady, Prague 10
Fakultni Thomayerova nemocnice
Onkologicka klinika1. LF UK a FTN, Videnska 750/800, Krc, Prague 4
Institut Paoli-Calmettes
Oncologie médicale, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Centre Antoine Lacassagne
Centre Antoine Lacassagne, 33 Avenue De Valombrose, 06189, Nice Cedex 2
Nouvelle Clinique Des Dentellieres
Centre Les Dentellières, 8 Avenue Vauban, 59300, Valenciennes
Institut Gustave Roussy
Oncologie médicale, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut De Cancerologie De L Ouest
Institut de Cancérologie de l’Ouest, Bd Du Professeur Jacques Monod, 44800, St Herblain
Medipole De Nancy
Centre d'Oncologie de Gentilly, 2 Rue Marie Marvingt, 54100, Nancy
Centre Hospitalier Universitaire D'Angers
Urologie, 4 Rue Larrey, 49100, Angers
Centre Hospitalier Regional Et Universitaire De Brest
Oncologie, Boulevard Tanguy Prigent, 29200, Brest
Hopital Prive Toulon Hyeres Sainte Marguerite
Hôpital Privé Toulon Hyeres, Avenue Alexis Godillot, 83400, Hyeres
Besancon University Hospital Center
Oncologie Médicale, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
Institut De Cancerologie Strasbourg Europe
Institut de Cancérologie de Strasbourg, 17 Rue Albert Calmette, 67200, Strasbourg
Centre Hospitalier Universitaire Grenoble Alpes
Oncologie Médicale, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Centre Francois Baclesse
Centre François Baclesse, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Hospital Foch
Urologie, 40 Rue Worth, 92150, Suresnes
Les Hopitaux Universitaires De Strasbourg
Oncologie Médicale, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Athens Medical Center S.A.
Department of Medical Oncology, Distomou 5-7, 151 25, Maroussi
General University Hospital Of Larissa
Department of Medical Oncology, P. O. Box 1425, 411 10, Larissa
European Institute Of Oncology S.r.l.
Oncology, Via Giuseppe Ripamonti 435, 20141, Milan
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Oncology Division, Piazzale Spedali Civili 1, 25123, Brescia
Azienda USL Toscana Sud Est
Oncology, Ospedale Area Aretina Nord, Via Pietro Nenni 20/22, Arezzo
Azienda Ospedaliero Universitaria Parma
Oncology, Viale Antonio Gramsci 14, 43126, Parma
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej
N/A, Ul. Terebelska 57/65, 21-500, Biala Podlaska
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Kilinka Nowotworów Układu Moczowego, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Ambulatorium Chemioterapii, Ul. Izabeli Romanowskiej 2, 85-796, Bydgoszcz
Copernicus Podmiot Leczniczy Sp. z o.o.
N/A, Al. Zwyciestwa 31/32, 80-219, Gdansk
Uniwersytecki Szpital Kliniczny W Poznaniu
Klinika Onkologii, Oddział Chemioterapii, Ul. Augustyna Szamarzewskiego 84, 60-569, Poznan
Centrul De Oncologie SF Nectarie S.R.L.
Oncologie, Strada Caracal Nr 109, 200542, Craiova
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Oncologie, Soseaua Fundeni 252, 022328, Bucharest
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Oncologie, Strada Republicii 34-36, 400015, Cluj-Napoca
Hospital Universitario Marques De Valdecilla
Oncology, Avenida Valdecilla Sn, 39008, Santander
Parc Tauli Hospital Universitari
Oncology, Parc Del Tauli 1 Edifici Santa Fe Ala Izquierda Planta 2ª, 08208, Sabadell
University Hospital Virgen Del Rocio S.L.
MEDICAL ONCOLOGY, Avenida De Manuel Siurot S/n, 41013, Sevilla
Vall D'hebron Institut De Recerca
Oncology-Genitourinary, Passeig De La Vall D'hebron 119-129, 08035, Barcelona
Hospital General Universitario Reina Sofia
Oncology, Avenida Menendez Pidal S/n, 14004, Cordoba
Complexo Hospitalario Universitario De Santiago
Oncology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Universidad De Navarra
MEDICAL ONCOLOGY, Irunlarrea Kalea S/n, 31008, Pamplona
Fundacion Instituto Valenciano De Oncologia
MEDICAL ONCOLOGY, Calle Professor Beltran Baguena 8, 46009, Valencia
Hospital Del Mar
ONCOLOGY, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
MD Anderson Cancer Center
Oncology, Calle De Arturo Soria Nº 270, 28033, 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 |
|---|---|---|---|---|---|
| Austria | 2019-07-05 | 2019-07-08 | 2020-03-05 | ||
| Czechia | 2019-08-02 | 2019-08-19 | 2020-07-06 | ||
| France | 2019-06-21 | 2019-06-24 | 2020-07-05 | ||
| Greece | 2024-04-09 | 2026-03-31 | 2026-03-31 | ||
| Italy | 2019-11-07 | 2019-11-20 | 2020-07-07 | ||
| Poland | 2019-08-07 | 2019-08-14 | 2020-07-09 | ||
| Romania | 2020-02-25 | 2020-03-05 | 2020-07-02 | ||
| Spain | 2019-06-11 | 2019-07-18 | 2020-07-06 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 83 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-508264-29-00 GR Redacted | 01 eu |
| Protocol (for publication) | D1_Protocol 2023-508264-29-00 Redacted | 01 EU |
| Protocol (for publication) | D1_Protocol Admin Letter_2023-508264-29-00_Redacted | N/A |
| Protocol (for publication) | D1_Protocol admin Letter_2023-508264-29-00_Redacted | N/A |
| Protocol (for publication) | D1_Protocol admin letter_Redacted | NA |
| Protocol (for publication) | D4_Blank statement_Patient facing documents-Questionnaires_ES | N/A |
| Protocol (for publication) | D4_Patient Facing Document_ questionnaire_blank statement_CZ | 1 |
| Protocol (for publication) | D4_Patient Facing Document_ questionnaire_blank statment_IT | 1 |
| Protocol (for publication) | D4_Patient facing documents_Blank Statement | N/A |
| Protocol (for publication) | D4_Patient facing documents_Blank Statement_AT | N/A |
| Protocol (for publication) | D4_Patient facing documents_Blank Statement_GR | 1 |
| Protocol (for publication) | D4_Patient facing documents_Blank Statement_RO | 1 |
| Protocol (for publication) | D4_Patient facing documents_FKSI-19_GR | 2.0 |
| Protocol (for publication) | D4_Patient facing documents_Statement on Questionnaires under licence_FR | 1 |
| Recruitment arrangements (for publication) | K1 Recruitment Arrangements_blank document_PL | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_blank document_CZ | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_blank document_ES | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_blank document_FR | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_blank document_GR | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_blank document_IT | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_blank document_RO | 1 |
| Subject information and informed consent form (for publication) | L 1 SIS and ICF addendum Redacted PL | 5 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main adult_addendum_IT | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main adult_IT_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnant partner_IT_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Travel reimbursment_IT_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Treatement beyond progression_IT | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_ SAE_IT_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum_Patient reimbursement_PL redacted | 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 Add | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum 02_FR_20209023 | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum 03_FR_20211028 | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum 1_CZ | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum 2_CZ | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum 3_CZ | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum 4_CZ | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum SAE_ PL _Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum_ES_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Additionnal treatment after progression_FR_20190327 | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Data Privacy_ PL Redacted | N/A |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for Continuing Treatment beyond Disease Progression | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for PPs Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for SAEs Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Greenphire | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main PL_Redacted | 2 |
| 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 main_Add PL | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main_Addendum PL | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main_CZ | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_ES_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_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 AE_FR_20190327 | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional biopsy C1J15_FR_20190327 | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional biopsy progression_FR_20190327 | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional biopsy_ PL | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Biopsy_C1D15_CZ | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Biopsy_ES | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Biopsy_UDR SAE_CZ | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Biopsy_UP_CZ | 1.1 |
| 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 Pregnant_Partner_ES_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF SAE | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF SAE_ES | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF TBP_ES | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment Beyond Progression_CZ | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CN_CZ_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Notification Letter_CZ | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_RO-Patient notification letter_RO | NA |
| Subject information and informed consent form (for publication) | L2_Other subject information Patient Notification Letter | NA |
| Subject information and informed consent form (for publication) | LI_SIS and ICF for OGR | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis EU CT 2023-508264-29_CZ | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis EU CT 2023-508264-29_GR | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis EU CT 2023-508264-29_PL | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis IT_2023-508264-29 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-508264-29_FR | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_AT_EU CT 2023-508264-29 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG_2023-508264-29-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_2023-508264-29-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_RO_EU CT 2023-508264-29 | 1.0 |
Application history
16 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-15 | Poland | Acceptable 2024-01-30
|
2024-01-30 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-14 | Poland | Acceptable 2024-09-20
|
2024-09-20 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-10-10 | Poland | Acceptable 2024-11-25
|
2024-11-26 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-01-07 | Acceptable | 2025-02-12 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-02-13 | 2025-02-13 | ||
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-02-13 | 2025-02-13 | ||
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-03-12 | Poland | 2025-03-12 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-04-22 | 2025-04-22 | ||
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-05-02 | Poland | 2025-05-02 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-05-20 | Poland | Acceptable 2025-07-21
|
2025-07-22 |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-08-20 | Poland | Acceptable 2025-07-21
|
2025-08-20 |
| 12 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-08-26 | Acceptable | 2025-10-03 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-10-28 | Poland | Acceptable 2025-11-30
|
2025-12-01 |
| 14 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-12-23 | Poland | Acceptable 2026-02-26
|
2026-02-27 |
| 15 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2026-04-20 | Acceptable 2026-02-26
|
2026-04-20 | |
| 16 | NON SUBSTANTIAL MODIFICATION | NSM-8 | 2026-04-21 | Poland | Acceptable 2026-02-26
|
2026-04-21 |