Overview
Sponsor-declared trial summary
Phase
Phase II and Phase III (Integrated)
Status
Ongoing, recruiting
Participants planned
317
Countries
5
Sites
17
Relapsed or Refractory Diffuse Large B-Cell Lymphoma
1. To evaluate the safety and tolerability and to establish a RP2D of zilovertamab vedotin when used in combination with R-GemOx or BR. 2. To compare zilovertamab vedotin in combination with R-GemOx to R-GemOx with respect to OS in part 2 of the study. 3. To compare zilovertamab vedotin in combination with R-GemOx to R…
Key facts
- Sponsor
- Merck Sharp & Dohme LLC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 24 Jun 2022 → ongoing
- Decision date (initial)
- 2026-04-08
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Merck Sharp & Dohme LLC
External identifiers
- EU CT number
- 2022-502646-27-00
- EudraCT number
- 2021-003313-18
- WHO UTN
- U1111-1285-0898
- ClinicalTrials.gov
- NCT05139017
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety, Pharmacokinetic, Therapy
1. To evaluate the safety and tolerability and to establish a RP2D of zilovertamab vedotin when used in combination with R-GemOx or BR.
2. To compare zilovertamab vedotin in combination with R-GemOx to R-GemOx with respect to OS in part 2 of the study.
3. To compare zilovertamab vedotin in combination with R-GemOx to R-GemOx with respect to PFS per Lugano response criteria by BICR in part 2 of the study.
4. Not Applicable: To compare zilovertamab vedotin in combination with BR to BR with respect to PFS per Lugano response criteria by BICR in part 2 of the study.
Secondary objectives 5
- Not Applicable: To compare zilovertamab vedotin in combination with BR to BR with respect to OS in part 2 of the study.
- To compare zilovertamab vedotin in combination with R-GemOx to R-GemOx with respect to ORR per Lugano response criteria as assessed by BICR in part 2 of the study.
- Not Applicable: To compare zilovertamab vedotin in combination with BR to BR with respect to ORR per Lugano response criteria by BICR in part 2 of the study.
- To evaluate zilovertamab vedotin in combination with R-GemOx and R-GemOx with respect to DOR per Lugano response criteria as assessed by BICR in part 2 of the study.
- Not Applicable: To evaluate zilovertamab vedotin in combination with BR and BR with respect to DOR per Lugano response criteria as assessed by BICR in part 2 of the study.
Conditions and MedDRA coding
Relapsed or Refractory Diffuse Large B-Cell Lymphoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10012820 | Diffuse large B-cell lymphoma NOS | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Has a histologically confirmed diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL).
- Has radiographically measurable DLBCL per the Lugano Response Criteria, as assessed locally by the investigator.
- Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 within 7 days prior to study treatment initiation.
- Has adequate organ function.
- Is able to provide new or archival tumor tissue sample not previously irradiated.
- Zilovertamab vedotin plus R-GemOx, or R-GemOx study arms: - Has relapsed or refractory DLBCL and is ineligible for or have failed autologous stem-cell transplant (ASCT) and have failed at least 1 line of prior therapy. - Has post-chimeric antigen receptor T (post-CAR-T) cell therapy failure or is ineligible for CAR-T cell therapy.
- Not Applicable: Zilovertamab vedotin plus Bendamustine Rituximab (BR), and Bendamustine Rituximab study arms: - Has relapsed or refractory DLBCL and is ineligible for or have failed ASCT and have failed at least 2 lines of prior therapy. - Has post-CAR-T therapy failure or is ineligible for CAR-T cell therapy.
Exclusion criteria 20
- Not Applicable: Has history of transformation of indolent disease to DLBCL.
- Has received solid organ transplant at any time.
- Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL).
- Has clinically significant (ie, active) cardiovascular disease or serious cardiac arrhythmia requiring medication.
- Has ongoing graft-versus-host disease (GVHD) of any grade, or is receiving treatment for their GVHD.
- Has clinically significant pericardial effusion or pleural effusion.
- Has ongoing Grade >1 peripheral neuropathy.
- Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.
- Has a demyelinating form of Charcot-Marie-Tooth disease.
- Has contraindication to any of the study intervention components including but not limited to prior anaphylactic reaction.
- Has received prior systemic anticancer therapy, including investigational agents within 4 weeks prior to the first dose of study intervention.
- Has received prior radiotherapy within 4 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
- Has ongoing corticosteroid therapy.
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.
- Has known active central nervous system (CNS) lymphoma involvement or active CNS involvement by lymphoma. Participants with prior CNS involvement are eligible if their CNS disease is in radiographic, cytological (for cerebrospinal fluid disease), and clinical remission.
- Has an active infection requiring systemic therapy.
- Has a known history of human immunodeficiency virus (HIV) infection.
- Has a known active Hepatitis C virus infection.
- Has a known psychiatric or substance abuse disorder that would interfere with the participant’s ability to cooperate with the requirements of the study.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 5
- Percentage of Participants with Dose-limiting Toxicities (DLTs)
- Percentage of Participants with Adverse Events (AEs)
- Percentage of Participants who Discontinue Study Treatment due to AE
- Overall Survival (OS)
- Progression-Free Survival (PFS)
Secondary endpoints 2
- Objective Response Rate (ORR)
- Duration of Response (DOR)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 10
SUB00696MIG · Substance
- Active substance
- Bendamustine Hydrochloride
- Pharmaceutical form
- POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 90 mg/m2 milligram(s)/sq. meter
- Max total dose
- 1080 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 15 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
MabThera 500 mg concentrate for solution for infusion
PRD2154043 · Product
- Active substance
- Rituximab
- Substance synonyms
- CT-P10, PF-05280586, ABP 798, BI 695500, JHL1101, HLX01
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 375 mg/m2 milligram(s)/sq. meter
- Max total dose
- 2250 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 15 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XC02 — RITUXIMAB
- Marketing authorisation
- EU/1/98/067/002
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
MabThera 100 mg concentrate for solution for infusion
PRD2154041 · Product
- Active substance
- Rituximab
- Substance synonyms
- CT-P10, PF-05280586, ABP 798, BI 695500, JHL1101, HLX01
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 375 mg/m2 milligram(s)/sq. meter
- Max total dose
- 2250 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 15 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XC02 — RITUXIMAB
- Marketing authorisation
- EU/1/98/067/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9635968 · Product
- Active substance
- Zilovertamab Vedotin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 2.5 mg/kg milligram(s)/kilogram
- Max total dose
- 15 mg/kg milligram(s)/kilogram
- Max treatment duration
- 15 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD9357099 · Product
- Active substance
- Zilovertamab Vedotin
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 2.5 mg/kg milligram(s)/kilogram
- Max total dose
- 15 mg/kg milligram(s)/kilogram
- Max treatment duration
- 15 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
Ruxience 500 mg concentrate for solution for infusion
PRD7980794 · Product
- Active substance
- Rituximab
- Substance synonyms
- CT-P10, PF-05280586, ABP 798, BI 695500, JHL1101, HLX01
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 375 mg/m2 milligram(s)/sq. meter
- Max total dose
- 2250 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 15 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FA01 — -
- Marketing authorisation
- EU/1/20/1431/002
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Ruxience 100 mg concentrate for solution for infusion
PRD7980793 · Product
- Active substance
- Rituximab
- Substance synonyms
- CT-P10, PF-05280586, ABP 798, BI 695500, JHL1101, HLX01
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 375 mg/m2 milligram(s)/sq. meter
- Max total dose
- 2250 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 15 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FA01 — -
- Marketing authorisation
- EU/1/20/1431/001
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Truxima 500 mg concentrate for solution for infusion
PRD4797328 · Product
- Active substance
- Rituximab
- Substance synonyms
- CT-P10, PF-05280586, ABP 798, BI 695500, JHL1101, HLX01
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 375 mg/m2 milligram(s)/sq. meter
- Max total dose
- 2250 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 15 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FA01 — -
- Marketing authorisation
- EU/1/16/1167/001
- MA holder
- CELLTRION HEALTHCARE HUNGARY KFT
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1686259 · ATC
- Active substance
- Gemcitabine
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 1000 mg/m2 milligram(s)/sq. meter
- Max total dose
- 6000 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 15 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BC05 — GEMCITABINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09490MIG · Substance
- Active substance
- Oxaliplatin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 100 mg/m2 milligram(s)/sq. meter
- Max total dose
- 600 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 15 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 1
-
L03A · Product
- Pharmaceutical form
- -
- Route of administration
- INTRAVENOUS
- Max daily dose
- 0 million IU million international units
- Max total dose
- 0 million IU million international units
- Max treatment duration
- 15 Week(s)
- Authorisation status
- Authorised
- ATC code
- L03A — IMMUNOSTIMULANTS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Merck Sharp & Dohme LLC
- Sponsor organisation
- Merck Sharp & Dohme LLC
- Address
- 126 East Lincoln Avenue
- City
- Rahway
- Postcode
- 07065-4607
- Country
- United States
Scientific contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Nishitha Reddy
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Nishitha Reddy
Third parties 6
| Organisation | City, country | Duties |
|---|---|---|
| Iqvia Limited ORG-100008655
|
Livingston, United Kingdom | Laboratory analysis |
| Oracle Corp. ORG-100007842
|
Redwood City, United States | E-data capture |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Interactive response technologies (IRT) |
| Parexel International Corp. ORG-100007310
|
Auburndale, United States | Other |
| Bioclinica Inc. ORG-100033079
|
Princeton, United States | Other |
Locations
5 EU/EEA countries · 17 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Authorised, recruiting | 2 | 1 |
| France | Ongoing, recruiting | 5 | 2 |
| Greece | Ongoing, recruiting | 6 | 3 |
| Italy | Ongoing, recruiting | 7 | 2 |
| Poland | Ongoing, recruiting | 17 | 9 |
| Rest of world
Colombia, Peru, Israel, New Zealand, Thailand, United Kingdom, Chile, Korea, Republic of, Mexico, United States, Brazil, Argentina, Turkey, Ukraine, Australia, Guatemala, Hong Kong, Canada, China, Costa Rica
|
— | 280 | — |
Investigational sites
Region Midtjylland
Department of Hematology, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Centre Hospitalier Lyon Sud
Service d’Hématologie Clinique, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Assistance Publique Hopitaux De Paris
Service d’Hématologie Clinique, 47 Boulevard De L Hopital, 75651, Paris Cedex 13
University General Hospital Of Alexandroupoli
Hematology Department, 6th Km Alex Polis Makris, Dragana, Alexandroupoli
Laiko General Hospital Of Athens
Hematology Department, Agiou Thoma (goudi) 17, 115 27, Athens
Evangelismos S.A.
Hematology and Lymphoma Department, Ipsiladou 45-47, 106 76, Athens
IRCCS Istituto Nazionale Tumori Fondazione Pascale
S.C. di Ematologia Oncologica, Via Mariano Semmola 52, 80131, Naples
Humanitas Research Hospital
U.O. di Oncologia medica ed Ematologia, Via Alessandro Manzoni 56, 20089, Rozzano
Pratia Hematologia Sp. z o.o.
Pratia Onkologia Katowice, Ul. Tadeusza Kosciuszki 92, 40-519, Katowice
Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego
Oddzial Hematologii, Ul. Alfreda Sokolowskiego 4, 58-309, Walbrzych
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Oddzial Kliniczny Hematologii i Chorob Wewnetrznych, Ul. Macieja Jakubowskiego 2, 30-688, Cracow
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.
Oddzial Hematologiczny, Ul. Hubalczykow 1, 76-200, Slupsk
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
Klinika Nowotworów Układu Chłonnego, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu
Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku, Ul. Wybrzeze Ludwika Pasteura 4, 50-367, Wroclaw
Centrum Onkologii Ziemi Lubelskiej Im Sw Jana Z Dukli
Oddział Hematologii i Transplantacjii Szpiku, Ul. Dra Kazimierza Jaczewskiego 7, 20-090, Lublin
Szpitale Pomorskie Sp. z o.o.
Oddział Hematologii i Transplantologii Szpiku, Ul. Powstania Styczniowego 1, 81-519, Gdynia
Pratia S.A.
Pratia MCM Kraków, Ul. Pana Tadeusza 2, 30-727, Cracow
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 |
|---|---|---|---|---|---|
| Denmark | 2026-05-07 | ||||
| France | 2022-07-19 | 2023-09-21 | |||
| Greece | 2025-02-10 | 2025-02-12 | |||
| Italy | 2022-06-30 | 2023-04-17 | |||
| Poland | 2022-06-24 | 2022-07-01 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 50 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol Signature Page_for pub | 05OCT2022 |
| Protocol (for publication) | D1_Protocol_2022-502646-27_GRC_EL_SM06_for pub | 06R |
| Protocol (for publication) | D1_Protocol_2022-502646-27_SM06_for pub | 06R |
| Protocol (for publication) | D4_Copyright statement_EN_SM06_for pub | 04DEC2024 |
| Protocol (for publication) | D4_Subject questionnaire_eCOA_FRA_FR_for pub | 1.0 |
| Protocol (for publication) | D4_Subject questionnaire_eCOA_PL_for pub | 1.0 |
| Protocol (for publication) | D4_Subject questionnaire_ITA_IT_for pub | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_DNK_EN_AM02_for pub | 1.00 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_FRA_FR_for pub | 14MAR2022 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_FRA_FR_for pub | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_FRA_FR_for pub_ | 15DEC2021 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_GRC_EN_for pub | 26JUN2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_POL_PL_SM06_for pub | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_FRA_FR_for pub | 15DEC2021 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_POL_PL_for pub | 11OCT2021 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_FRA_FR_for pub | 22NOV2021 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_FRA_FR_for pub_ | 22NOV2021 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_POL_PL_SM06_for pub | 4.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Visit Guide_Cohort A_FRA_FR_for pub | 02.2R |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Visit Guide_Cohort B_FRA_FR_for pub | 02.1R |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Poster_FRA_FR_for pub | 22NOV2021 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Poster_POL_PL_SM06_for pub | 0.01 |
| Recruitment arrangements (for publication) | MK-2140-003_CTIS Placeholder document | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR assent_GRC_EL_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_DNK_EN_AM02_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_FRA_FR_for pub | 02R |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_ITA_IT_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_POL_PL_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR data privacy_ITA_IT_for pub | 18MAY2023 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum study changes_ITA_IT_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_DNK_DA_AM02-RFI001_for pub | AM04v4.0R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_FRA_FR_SM06_for pub | AM03v3.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_GRC_EL_SM06_for pub | AM4 4.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_ITA_IT_SM06_RFI001_for pub | AM04v4.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_POL_PL_SM06_for pub | AM04v4.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main data privacy_ITA_IT_for pub | 18MAY2023 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_DILI sample_ITA_IT_for pub | 18MAY2023 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_GRC_EL_for pub | AM01v.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner data privacy_ITA_IT_for pub | 18MAY2023 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner_ITA_IT_for pub | 18MAY2023 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_right not to know_DNK_DA_AM02_for pub | 00 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC RSI_RUXIENCE_Pfizer Limited_SM07_for pub | 10Oct2025 |
| Synopsis of the protocol (for publication) | D1_PPLS_2022-502646-27_FRA_FR_SM06_for pub | 03 |
| Synopsis of the protocol (for publication) | D1_PPLS_2022-502646-27_GRC_EL_SM06_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2022-502646-27_ITA_IT_SM06_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2022-502646-27_POL_PL_SM06_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2022-502646-27-00_SM06_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_2022-502646-27_ITA_IT_SM06_for pub | 4.0R |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_2022-502646-27-00_FRA_FR_for pub | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_2022-502646-27-00_POL_PL_for pub | 02 |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-02-28 | France | Acceptable 2023-04-27
|
2023-04-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-06-13 | France | Acceptable 2023-08-24
|
2023-08-24 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-02-08 | Acceptable | 2024-03-25 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-06-13 | France | Acceptable 2024-07-30
|
2024-07-30 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-08-22 | Acceptable | 2024-10-05 | |
| 6 | SUBSEQUENT ADDITION OF MSC | APP-6 | 2024-09-20 | Acceptable 2024-07-30
|
2024-12-10 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-03-28 | France | Acceptable 2025-07-15
|
2025-07-15 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-10-30 | Acceptable 2025-07-15
|
2025-10-30 | |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-11-11 | France | Acceptable 2025-07-15
|
2025-11-11 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-11-17 | France | Acceptable 2025-07-15
|
2025-11-17 |
| 11 | SUBSEQUENT ADDITION OF MSC | APP-11 | 2026-01-28 | Acceptable 2025-07-15
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2026-04-08 |