Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruiting
Participants planned
1,269
Countries
16
Sites
96
Hormone receptor positive breast cancer
1. To compare MK-2870 to TPC with respect to PFS per RECIST 1.1 as assessed by BICR in all participants. 2. To compare MK-2870 plus pembrolizumab to TPC with respect to PFS per RECIST 1.1 as assessed by BICR in all participants.
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
- 22 Aug 2024 → ongoing
- Decision date (initial)
- 2024-05-15
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Merck Sharp & Dohme LLC
External identifiers
- EU CT number
- 2023-504918-29-00
- WHO UTN
- U1111-1289-8119
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy, Safety, Pharmacokinetic
1. To compare MK-2870 to TPC with respect to PFS per RECIST 1.1 as assessed by BICR in all participants.
2. To compare MK-2870 plus pembrolizumab to TPC with respect to PFS per RECIST 1.1 as assessed by BICR in all participants.
Secondary objectives 13
- 1. To compare MK-2870 to TPC with respect to OS in all participants.
- 2. To compare MK-2870 plus pembrolizumab to TPC with respect to OS in all participants.
- 3. To compare MK-2870 plus pembrolizumab to MK-2870 with respect to PFS per RECIST 1.1 as assessed by BICR in all participants.
- 4. To compare MK-2870 plus pembrolizumab to MK-2870 with respect to OS in all participants.
- 5. To compare MK-2870 to TPC with respect to ORR per RECIST 1.1 as assessed by BICR in all participants.
- 6. To compare MK-2870 plus pembrolizumab to TPC with respect to ORR per RECIST 1.1 as assessed by BICR in all participants.
- 7. To evaluate MK-2870 to TPC with respect to DOR per RECIST 1.1 as assessed by BICR in all participants.
- 8. To evaluate MK-2870 plus pembrolizumab to TPC with respect to DOR per RECIST 1.1 as assessed by BICR in all participants.
- 9. To compare MK-2870 to TPC with respect to mean change from baseline in HRQoL using the EORTC QLQ-C30 in all participants.
- 10. To compare MK-2870 to TPC with respect to TTD in HRQoL using the EORTC QLQ-C30 in all participants.
- 11. To compare MK-2870 plus pembrolizumab to TPC with respect to mean change from baseline in HRQoL using the EORTC QLQ-C30 in all participants.
- 12. To compare MK-2870 plus pembrolizumab to TPC with respect to TTD in HRQoL using the EORTC QLQ-C30 in all participants.
- 13. To evaluate the safety and tolerability of MK-2870, MK-2870 plus pembrolizumab, and chemotherapy.
Conditions and MedDRA coding
Hormone receptor positive breast cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.0 | PT | 10083234 | Hormone receptor positive breast cancer | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- 1. Has unresectable locally advanced or metastatic hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer
- 2. Has radiographic disease progression on one or more lines of endocrine therapy for unresectable locally advanced/metastatic HR+/HER2- breast cancer, with one in combination with a CDK4/6 inhibitor.
- 3. Is a chemotherapy candidate
- 4. Has an eastern cooperative oncology group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization
- 5. Has adequate organ function
- 6. Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
- 7. Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
- 8. Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
Exclusion criteria 7
- 1. Has breast cancer amenable to treatment with curative intent
- 2. Has experienced an early recurrence (<6 months after completing adjuvant/neoadjuvant chemotherapy) and therefore is eligible to receive second-line (2L) treatment
- 3. Has symptomatic advanced/metastatic visceral spread at risk of rapidly evolving into life-threatening complications
- 4. Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer
- 5. Active autoimmune disease that has required systemic treatment in the past 2 years
- 6. History of (noninfectious) pneumonitis/interstitial lung disease that requires steroids, or has current pneumonitis/interstitial lung disease
- 7. Has an active infection requiring systemic therapy
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Progression-Free Survival (PFS) (MK-2870 versus treatment of physician’s choice [TPC]; MK-2870 + pembrolizumab versus TPC)
Secondary endpoints 16
- 1. Overall Survival (OS)
- 2. Progression-Free Survival (PFS) (MK-2870 + pembrolizumab versus MK-2870)
- 3. Objective Response Rate (ORR)
- 4. Duration of Response (DOR)
- 5. Change from baseline in global health status/quality of life scores, on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
- 6. Change from baseline in physical functioning score, on the EORTC QLQ-C30
- 7. Change from baseline in emotional functioning score, on the EORTC QLQ-C30
- 8. Change from baseline in fatigue score, on the EORTC QLQ-C30
- 9. Change from baseline in diarrhea score, on the EORTC QLQ-C30
- 10. Time to first Deterioration (TTD) in global health status/quality of life scores, on the EORTC QLQ-C30
- 11. TTD in physical functioning score, on the EORTC QLQ-C30
- 12. TTD in emotional functioning score, on the EORTC QLQ-C30
- 13. TTD in fatigue score, on the EORTC QLQ-C30
- 14. TTD in diarrhea score, on the EORTC QLQ-C30
- 15. Number of participants who experience one or more Adverse Events (AEs)
- 16. Number of participants who discontinue study treatment due to an AE
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
KEYTRUDA 25 mg/mL concentrate for solution for infusion
PRD4323105 · Product
- Active substance
- Pembrolizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 6933 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF02 — -
- Marketing authorisation
- EU/1/15/1024/002
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD12802980 · Product
- Active substance
- Sacituzumab Tirumotecan
- Substance synonyms
- Humanised IgG1 monoclonal antibody against TROP2, conjugated to KL610023, SKB264, MK-2870, Humanised IgG1 monoclonal antibody against TROP2, conjugated to sulfonylpyrimidine-polyethyleneglycol-lysine-methanesulfonyl belotecan
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 4 mg/kg milligram(s)/kilogram
- Max total dose
- 104 mg/kg milligram(s)/kilogram
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD11447874 · Product
- Active substance
- Sacituzumab Tirumotecan
- Substance synonyms
- Humanised IgG1 monoclonal antibody against TROP2, conjugated to KL610023, SKB264, MK-2870, Humanised IgG1 monoclonal antibody against TROP2, conjugated to sulfonylpyrimidine-polyethyleneglycol-lysine-methanesulfonyl belotecan
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 4 mg/kg milligram(s)/kilogram
- Max total dose
- 104 mg/kg milligram(s)/kilogram
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 5
SCP129816 · ATC
- Active substance
- Paclitaxel
- Substance synonyms
- ONCOGEL, ABI-007, MBT 0206
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 90 mg/m2 milligram(s)/sq. meter
- Max total dose
- 3510 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01CD01 — PACLITAXEL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP131876 · ATC
- Active substance
- Capecitabine
- Route of administration
- ORAL
- Max daily dose
- 1000 mg/m2 milligram(s)/sq. meter
- Max total dose
- 504000 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BC06 — CAPECITABINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP138158 · ATC
- Active substance
- Doxorubicin Hydrochloride
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 50 mg/m2 milligram(s)/sq. meter
- Max total dose
- 650 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01DB01 — DOXORUBICIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Doxorubicin Hydrochloride, Liposomal
SUB126795 · Substance
- Active substance
- Doxorubicin Hydrochloride, Liposomal
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 50 mg/m2 milligram(s)/sq. meter
- Max total dose
- 650 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB127678 · Substance
- Active substance
- Paclitaxel Albumin-Bound
- Pharmaceutical form
- POWDER FOR DISPERSION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 100 mg/m2 milligram(s)/sq. meter
- Max total dose
- 3900 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 4
SCP10332310 · ATC
- Active substance
- Dexamethasone Acetate
- Route of administration
- ORAL
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
R06A · Product
- Pharmaceutical form
- -
- Route of administration
- ORAL
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- R06A — ANTIHISTAMINES FOR SYSTEMIC USE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1081917 · ATC
- Active substance
- Buclizine Hydrochloride
- Substance synonyms
- Buclizine dihydrochloride
- Route of administration
- ORAL
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- N02BE01 — PARACETAMOL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
A02BA · Product
- Active substance
- H2-Receptor Antagonists
- Pharmaceutical form
- -
- Route of administration
- ORAL
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- A02BA — H2-Receptor Antagonists
- 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
- Paolo D’Amico
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Paolo D’Amico
Third parties 7
| Organisation | City, country | Duties |
|---|---|---|
| Parexel International Corp. ORG-100007310
|
Auburndale, United States | Other |
| Hematogenix Laboratory Services LLC ORG-100040020
|
Tinley Park, United States | Other, Laboratory analysis |
| Roche Tissue Diagnostics ORL-000005553
|
Tucson, United States | Laboratory analysis |
| Signant Health Global Solutions Limited ORG-100047290
|
Dublin 2, Ireland | Interactive response technologies (IRT), E-data capture |
| Roche Diagnostics GmbH ORG-100003819
|
Penzberg, Germany | Other, Laboratory analysis |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Other |
| IQVIA Limited ORG-100008655
|
Livingston, United Kingdom | Laboratory analysis |
Locations
16 EU/EEA countries · 96 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 20 | 5 |
| Czechia | Ongoing, recruiting | 20 | 6 |
| Denmark | Ongoing, recruiting | 21 | 5 |
| France | Ongoing, recruiting | 30 | 7 |
| Germany | Ongoing, recruiting | 50 | 10 |
| Greece | Ongoing, recruiting | 25 | 6 |
| Hungary | Ongoing, recruiting | 23 | 6 |
| Ireland | Ongoing, recruiting | 18 | 3 |
| Italy | Ongoing, recruiting | 30 | 9 |
| Netherlands | Ongoing, recruiting | 25 | 7 |
| Norway | Ended | 14 | 4 |
| Poland | Ongoing, recruitment ended | 70 | 11 |
| Portugal | Ongoing, recruiting | 15 | 3 |
| Romania | Ongoing, recruitment ended | 16 | 4 |
| Spain | Ongoing, recruiting | 45 | 7 |
| Sweden | Ongoing, recruiting | 16 | 3 |
| Rest of world
United States, China, Brazil, India, Korea, Republic of, Israel, Chile, Mexico, Taiwan, Canada, Argentina, Australia, Hong Kong, New Zealand, Singapore, Philippines, South Africa, Costa Rica, Turkey, United Kingdom, Switzerland, Japan, Colombia, Puerto Rico, Peru, Malaysia
|
— | 831 | — |
Investigational sites
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Clinique du sein Godinne, Avenue Docteur Gaston Therasse 1, 5530, Yvoir
Az Maria Middelares Gent
Medical Oncology, Buitenring-Sint-Denijs 30, 9000, Gent
Jessa Ziekenhuis
Medical Oncology, Stadsomvaart 11, 3500, Hasselt
Cliniques Universitaires Saint-Luc
Service oncologie médicale, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Institut Jules Bordet
Medical Oncology, Mijlenmeersstraat 90, 1070, Anderlecht
University Hospital Olomouc
Onkologická klinika, Zdravotniku 248/7, 779 00, Olomouc
Fakultni Nemocnice V Motole
Onkologická klinika 2. LF UK a FN Motol, V Uvalu 84/1, Motol, Prague
Nemocnice Ceske Budejovice a.s.
Onkologické oddělení, B. Nemcove 585/54, 370 01, Ceske Budejovice
Fakultni Nemocnice Kralovske Vinohrady
Onkologická klinika, Srobarova 1150/50, Vinohrady, Prague 10
Fakultni Nemocnice Brno
Interní hematologická a onkologická klinika, Jihlavska 340/20, Bohunice, Brno
Fakultni Nemocnice Ostrava
Klinika onkologická, 17. Listopadu 1790/5, Poruba, Ostrava
Rigshospitalet
Center for Kræft og Organsygdomme, Blegdamsvej 9, 2100, Copenhagen Oe
Odense University Hospital
Onkologisk Afdelig R, J B Winsloews Vej 4, 5000, Odense C
Nordsjaellands Hospital
Onkologisk og Palliativ afdeling, Dyrehavevej 29, 3400, Hilleroed
Næstved Hospital
Onkologisk afdeling, Ringstedgade 61, 4700, Næstved
Lillebaelt Hospital
Onkologisk afdeling, Beriderbakken 4, 7100, Vejle
Institut Curie
Departement d'oncologie médicale, 26 Rue D Ulm, 75005, Paris
University Hospitals Pitie Salpetriere Charles Foix
Service d'oncologie médicale, 47 To 83 Boulevard De L Hopital, 75013, Paris
Centre Francois Baclesse
NA, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
L'Hopital Prive Du Confluent
Service d'oncologie médicale, 4 Rue Eric Tabarly, 44277, Nantes Cedex 2
Centre Hospitalier Universitaire De Poitiers
Pôle régional de cancérologie, 2 Rue De La Miletrie, 86000, Poitiers
Centre De Cancerologue Du Grand Montpellier
NA, 25 Rue De Clementville, 34070, Montpellier
Hopital Prive Jean Mermoz
Service d'oncologie médicale, 55 Avenue Jean Mermoz, 69008, Lyon
Franziskus Hospital Harderberg
Zentrum für Onkologie und Hämatologie MVZ II, Alte Rothenfelder Strasse 23, Harderberg, Georgsmarienhuette
SRH Wald-Klinikum Gera GmbH
Brustzentrum Ostthüringen, Strasse Des Friedens 122, Debschwitz, Gera
Caritas Traegergesellschaft Saarbruecken mbH (CTS)
Klinik für Frauenheilkunde, Rheinstrasse 2, Malstatt, Saarbruecken
HELIOS Klinikum Berlin-Buch GmbH
Klinik für Gynäkologie und Geburtshilfe, Schwanebecker Chaussee 50, Buch, Berlin
St. Vincenz-Krankenhaus GmbH
Frauen- und Kinderklinik St. Louise, Husener Strasse 81, Kernstadt, Paderborn
Klinikum Ernst von Bergmann gGmbH
Klinik für Gynäkologie und Geburtshilfe, Charlottenstrasse 72, Noerdliche Innenstadt, Potsdam
Universitaetsklinikum Erlangen AöR
Department of Obstetrics & Gynecology, Universitaetsstrasse 21-23, Innenstadt, Erlangen
LMU Klinikum Muenchen AöR
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Ziemssenstrasse 1, Ludwigsvorstadt-Isarvorstadt, Munich
Universitaetsklinikum Duesseldorf AöR
Klinik für Frauenheilkunde und Geburtshilfe, Moorenstrasse 5, Bilk, Duesseldorf
KEM I Evang. Kliniken Essen-Mitte gGmbH
Klinik für Senologie/Brustzentrum, Henricistrasse 92, Huttrop, Essen
Henry Dunant Hospital Center
2nd Oncology Clinic, 107 Mesogeion Avenue, 115 26, Athens
General University Hospital Of Larissa
Oncology department, P. O. Box 1425, 411 10, Larissa
Areteio Hospital
B' Surgery Department, Vassilissas Sofias Avenue 76, 115 28, Athens
Athens Medical Center S.A.
3rd Department of Oncology, Pylea, Asklipiou 10, Thessaloniki
European Interbalkan Medical Center
4th Department of Medical Oncology, Asklipiou 10, Pylea, Thessaloniki
Diagnostic & Therapeutic Center of Athens HYGEIA Single Member S.A.
3rd Oncology Department, Erithrou Stavrou 4, 151 24, Maroussi
Budapesti Uzsoki Utcai Korhaz
Onkoradiológiai Osztály, Uzsoki Utca 29-41, 1145, Budapest XIV
Zala Varmegyei Szent Rafael Korhaz
Onkológiai Osztály, Zrinyi Miklos Utca 1, 8900, Zalaegerszeg
University Of Szeged
Onkoterápiás Klinika, Koranyi Fasor 12, 6720, Szeged
University Of Debrecen
Onkológiai Klinika, Nagyerdei Korut 98, 4032, Debrecen
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Onkológiai Centrum, Tallian Gyula Utca 20-32, 7400, Kaposvar
Semmelweis Egyetem
Belgyógyászati és Onkológiai Klinika, Baross Utca 23, 1082, Budapest
St Vincent's University Hospital
Medical Oncology, Elm Park Merrion Road, D04 T6F4, Dublin 4
Bon Secours Hospital Cork
Medical Oncology, College Road, T12 DV56, Cork
Mater Misericordiae University Hospital
Oncology, Eccles Street, D07 R2WY, Dublin 7
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Oncologia ed Ematologia, Via Pietro Albertoni 15, 40138, Bologna
European Institute Of Oncology S.r.l.
Divisione di Senologia Medica, Via Giuseppe Ripamonti 435, 20141, Milan
Ospedale San Raffaele S.r.l.
Oncologia Medica, Via Olgettina 60, 20132, Milan
Humanitas Research Hospital
Oncologia Medica, Via Alessandro Manzoni 56, 20089, Rozzano
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Dipartimento di Oncologia, Via Piero Maroncelli 40, 47014, Meldola
Centro Di Riferimento Oncologico Di Aviano
SOC di Oncologia Medica e Prevenzione Oncologica, Via Franco Gallini 2, 33081, Aviano
Fondazione IRCCS Istituto Nazionale Dei Tumori
Struttura Complessa Oncologia Medica 1, Via Giacomo Venezian 1, 20133, Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Oncologia Medica, Largo Francesco Vito 1, 00168, Rome
IRCCS Ospedale Policlinico San Martino
Clinica di Oncologia Medica Padiglione 41, Largo Rosanna Benzi 10, 16132, Genoa
Isala Klinieken Stichting
Medical Oncology, Dokter Van Heesweg 2, 8025 AB, Zwolle
University Hospital Maastricht
Medical Oncology, P Debyelaan 25, 6229 HX, Maastricht
Catharina Ziekenhuis Stichting
Medical Oncology, Michelangelolaan 2, 5623 EJ, Eindhoven
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Medical Oncology, Plesmanlaan 121, 1066 CX, Amsterdam
Rijnstate Ziekenhuis Stichting
Medical Oncology, Wagnerlaan 55, 6815 AD, Arnhem
Meander Medisch Centrum Stichting
Medical Oncology, Maatweg 3, 3813 TZ, Amersfoort
Amphia Hospital
Medical Oncology, Molengracht 21, 4818 CK, Breda
Helse Stavanger HF
Department of Haematology and Oncology, Gerd-Ragna Bloch Thorsens Gate 8, 4011, Stavanger
Oslo University Hospital HF
Department of Oncology, Taarnbygget, Kirkeveien 166, Oslo
Helse Bergen HF
Department of Cancer Treatment and Medical Physics, Jonas Lies Vei 65, 5021, Bergen
Drammen Sykehus
Department of Oncology, Dronninggata 28, 3004, Drammen
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Ambulatorium Chemioterapii, Ul. Izabeli Romanowskiej 2, 85-796, Bydgoszcz
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku
Oddział Onkologii Klinicznej im. dr E. Pileckiej z pododdziałem Chemioterapii Dziennej, Ul. Ogrodowa 12, 15-027, Bialystok
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.
Siedleckie Centrum Onkologii Oddział Onkologii Klinicznej i Radioterapii, Ul. Ksiecia Jozefa Poniatowskiego 26, 08-110, Siedlce
Mruk-Med I Sp. z o.o.
NA, Ul. Gen. Mariana Langiewicza 61, 35-021, Rzeszow
Zachodniopomorskie Centrum Onkologii
Ośrodek Badań Klinicznych, Ul. Strzalowska 22, 71-730, Szczecin
Szpitale Pomorskie Sp. z o.o.
Szpital Morski im. PCK Oddział Onkologii Klinicznej, Ul. Powstania Styczniowego 1, 81-519, Gdynia
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Nowotworów Piersi i Chirurgii Rekonstrukcyjnej, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
Klinika Onkologii Klinicznej Dział Chemioterapii, Ul. Prezydenta Stefana Artwinskiego 3, 25-734, Kielce
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Oddział Onkologii Klinicznej z Pododdziałem Chemioterapii Jednodniowej, Ul. Tytusa Chalubinskiego 7, 75-581, Koszalin
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Centrum Diagnostyki i Leczenia Chorób Piersi, Ul. Wybrzeze Armii Krajowej 15, 44-102, Gliwice
Mazowiecki Szpital Onkologiczny Sp. z o.o.
Poradnia Onkologiczna, Ul. Koscielna 61, 05-135, Wieliszew
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Medical Oncology Departament, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
Unidade Local De Saude De Santa Maria E.P.E.
Oncology Department, Avenida Professor Egas Moniz, 1649-035, Lisbon
Unidade Local De Saude De Amadora Sintra E.P.E.
Oncology Department, Itinerario Complementar 19, 2720-276, Amadora
Radiotherapy Center Cluj S.R.L.
Oncologie Medicala, Str. Razoare Nr. 486g Jud. Cluj, 407280, Floresti
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Oncologie Medicala, Strada Republicii 34-36, 400015, Cluj-Napoca
Mnt Healthcare Europe S.R.L.
Oncologie Medicala, Bulevardul Ficusului 40, 013975, Bucharest
Spitalul Clinic Filantropia
Oncologie Medicala, Bulevardul Mihalache Ion 11-13, 011171, Bucharest
Hospital Beata Maria Ana
Oncology, Calle Del Doctor Esquerdo No. 83, 28007, Madrid
Hospital Universitario Quironsalud Madrid
Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitario Virgen De La Macarena
Oncology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Universitari Vall D Hebron
Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital General Universitario Reina Sofia
Oncology, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Clinico Universitario De Valencia
Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital General Universitario Gregorio Maranon
Oncology, Calle Del Doctor Esquerdo 46, 28007, Madrid
Karolinska University Hospital
Tema Cancer, ME Bröst-, endokrina tumörer och sarkom, Eugeniavagen 3, 171 64, Solna
Sodra Alvsborg Hospital-Vastra Gotalandsregionen
Onkologmottagning, Södra Älvsborgs Sjukhus, Bramhultsvagen 53, Boras Gustav Adolf, Boras
Uppsala University Hospital
Onkologikliniken, Akademiska Sjukhusest, Uppsala, Akademiska Sjukhuset, 751 85, Uppsala
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2024-11-06 | 2024-11-19 | |||
| Czechia | 2025-02-27 | 2025-05-02 | |||
| Denmark | 2024-11-25 | 2024-12-16 | |||
| France | 2024-08-29 | 2024-09-09 | |||
| Germany | 2025-07-15 | 2025-07-29 | |||
| Greece | 2024-09-18 | 2024-10-15 | |||
| Hungary | 2024-09-11 | 2024-10-11 | |||
| Ireland | 2024-11-21 | 2024-12-03 | |||
| Italy | 2024-10-08 | 2024-11-06 | |||
| Netherlands | 2024-08-22 | 2024-09-06 | |||
| Poland | 2024-09-05 | 2024-09-11 | 2025-10-23 | ||
| Portugal | 2024-10-23 | 2024-10-24 | |||
| Romania | 2024-09-11 | 2024-09-12 | 2025-11-07 | ||
| Spain | 2024-09-09 | 2024-09-09 | |||
| Sweden | 2024-11-21 | 2024-12-13 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Unexpected events 1 · Art. 53 CTR
Note: SUSARs are reported via EudraVigilance, not CTIS — events shown here are CTIS-public notifications only.
Unexpected event UE-55499
- Event date
- 2024-10-22
- Date aware
- 2024-10-22
- Submission date
- 2024-11-04
- Member states affected
- Belgium, Czechia, Denmark, France, Greece, Hungary, Ireland, Italy, Portugal, Romania, Spain, Sweden, Netherlands, Norway, Poland
- Clinical procedures
- N/A
- Event description
- The Sponsor has received information regarding a study participant who experienced Grade 4 keratitis with associated corneal perforation. The participant was then permanently discontinued from sac-TMT due to Grade 4 keratitis with the keratitis still ongoing. This case was reported as a SUSAR in Eudravigilance previously.
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 171 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2023-504918-29_GRC_EL_SM12_for pub | 04R |
| Protocol (for publication) | D1_Protocol_2023-504918-29_SM12_for pub | 04R |
| Protocol (for publication) | D4_Copyright Statement_AM01_for pub | 04DEC2024 |
| Protocol (for publication) | D4_Copyright Statement_SM08_for pub | 04DEC2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_BEL_EN_SM08-RFI006_for pub | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_CZE_CS_for pub | 17JAN2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_DEU_EN_AM01_for pub | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_DNK_EN_SM08_for pub | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_ESP_ES_for pub | 22JAN2024R |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_FRA_FR_for pub | 10JAN2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_GRC_EN_for pub | 28DEC2023 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_HUN_EN_for pub | 14JAN2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_IRL_EN_for pub | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_ITA_EN_for pub | 17JAN2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_NLD_EN_for pub | outofscope |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_POL_PL_SM12_for pub | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_PRT_EN_for pub | v1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_ROU_RO_for pub | 22JAN2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_SWE_SV_for pub | 1.0 |
| Recruitment arrangements (for publication) | K2 Recruitment Doc Website_POL_PL_SM12_for pub | 26SEP2025 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Master Tissue Brochure_DEU_DE_AM01_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Master Tissue Brochure_IRL_EN_for pub | 00-1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Master Tissue Brochure_MTB_GRC_EL_for pub | 000.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Master Tissue Brochure_ROU_RO_for pub | 00-1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_BEL_EN_SM12_for pub | 00.2 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_BEL_FR_SM12_for pub | 00.2 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_BEL_NL_SM12_for pub | 00.2 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_DEU_DE_AM01_for pub | 00.2 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_FRA_FR_SM10-RFI002_for pub | 00.2 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_IRL_EN_SM08_for pub | 00.2 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_NLD_NL_for pub | 00-1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_PB_GRC_EL_for pub | 000.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_POL_PL_SM12_for pub | 00.2 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_ROU_RO_for pub | 00-1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Print Ad_PP_GRC_EL_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Visit Guide_Arm A_BEL_EN_SM12_for pub | 03.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Visit Guide_Arm A_BEL_FR_SM12_for pub | 03.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Visit Guide_Arm A_BEL_NL_SM12_for pub | 03.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Visit Guide_ARM A_GRC_EL_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Visit Guide_Arm A_IRL_EN_SM12_for pub | 03.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Visit Guide_Arm B_BEL_EN_SM12_for pub | 03.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Visit Guide_Arm B_BEL_FR_SM12_for pub | 03.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Visit Guide_Arm B_BEL_NL_SM12_for pub | 03.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Visit Guide_ARM B_GRC_EL_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Visit Guide_Arm B_IRL_EN_SM12_for pub | 03.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Visit Guide_Arm C_BEL_ENG_SM12_for pub | 03.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Visit Guide_Arm C_BEL_FR_SM12_for pub | 03.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Visit Guide_Arm C_BEL_NL_SM12_for pub | 03.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Visit Guide_ARM C_GRC_EL_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Visit Guide_Arm C_IRL_EN_SM12_for pub | 03.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Poster_DEU_DE_AM01_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Poster_IRL_EN_for pub | 00-1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Poster_ROU_RO_for pub | 00-1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Study Card_Thank you _GRC_EL_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Subject Recruitment_NLD_NL_for pub | v1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Summary PIS_IRL_EN_SM12-RFI004_for pub | 03 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Website_POL_PL_SM12_for pub | 06JUN2025 |
| Subject information and informed consent form (for publication) | L1_ICF_Addendum progression_FRA_FR_for pub | v.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Genetic consent_HUN_HU_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Genetic consent_PRT_PT_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_BEL_EN_for pub | V0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_BEL_FR_for pub | V0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_BEL_NL_for pub | V0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_CZE_CS_for pub | Czech v1 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_DEU_DE_AM01_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_ESP_ES_SM08_for pub | 0.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_GRC_EL_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_HUN_HU_for pub | v0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_IRL_EN_for pub | v0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_ITA_IT_SM12_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_NLD_NL_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_POL_PL_SM08_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_PRT_PT_for pub | v0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_ROU_EN_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_ROU_RO_SM08_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_SWE_SV_for pub | 0-00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_BEL_EN_SM12_for pub | 2.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_BEL_FR_SM12_for pub | 2.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_BEL_NL_SM12_for pub | 2.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_CZE_CS_SM12_for pub | Czech v5R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_DEU_DE_SM12_for pub | AM02v2.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_DNK_DA_SM12-RFI003_for pub | AM02v2.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_ESP_ES_SM12_for pub | AM02v2.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_FRA_FR_SM12_for pub | AM02v2.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_GRC_EL_SM12_for pub | AM02v2.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_HUN_HU_SM12_for pub | AM02v2.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_IRL_EN_SM12-RFI004_for pub | AM02v2.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_ITA_IT_SM12_for pub | 2.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_NLD_NL_SM12_for pub | AM02v2.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_POL_PL_SM12_for pub | AM02v2.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_PRT_PT_SM12_for pub | AM02v2.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_ROU_EN_SM12_for pub | AM02v2.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_ROU_RO_SM12_for pub | AM02v2.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_SWE_SV_SM12_for pub | AM02 v2.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main data privacy_ITA_IT_SM12_for pub | 02OCT2025 |
| Subject information and informed consent form (for publication) | L1_ICF_Main GDPR_CZE_CS_for pub | CZE v3.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_addendum_progression consent_DNK_DA_for pub | v0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_data privacy_ITA_IT_SM12_for pub | 02OCT2025 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_DILI sample_ITA_IT_SM12_for pub | 02OCT2025 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_BEL_EN_SM08-RFI006_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_BEL_FR_SM08-RFI006_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_BEL_NL_SM08-RFI006_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_CZE_CS_SM12_for pub | Czech v1 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_GRC_EL_SM12_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_IRL_EN_SM08_for pub | 00b |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_PRT_PT_SM08_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_ROU_EN_SM08_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_ROU_RO_SM08_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_SWE_SV_SM08_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_BEL_EN_SM12_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_BEL_FR_SM12_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_BEL_NL_SM12_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_DNK_DA_SM12_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_ESP_ES_SM12_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_GRC_EL_SM12_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_ITA_IT_SM12_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_POL_PL_SM12_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_PRT_PT_SM12_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_ROU_EN_SM12_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_ROU_RO_SM12_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnancy follow-up_BEL_EN_for pub | 0-00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnancy follow-up_BEL_FR_for pub | 0-00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnancy follow-up_BEL_NL_for pub | 0-00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnancy follow-up_DEU_DE_AM01-RFI001_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnancy follow-up_ESP_ES_SM08_for pub | 0.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnancy follow-up_PRT_PT_for pub | v0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner_BEL_EN_SM12-RFI005_for pub | v0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner_BEL_FR_SM12-RFI005_for pub | v0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner_BEL_NL_SM12-RFI005_for pub | v0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner_DEU_DE_AM01-RFI001_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner_ESP_ES_SM08_for pub | 0.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner_HUN_HU_SM12_for pub | 0.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_prescreening_CZE_CS_SM12_for pub | Czech v2 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_prescreening_FRA_FR_SM12_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_prescreening_HUN_HU_SM12_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_prescreening_IRL_EN_SM12-RFI004_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_right not to know_DNK_DA_SM12_for pub | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_screening consent_DEU_DE_SM12_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_tumor screening_NLD_NL_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_tumor screening_SWE_SV_SM12_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_withdrawal_PRT_PT_for pub | 08APR2024 |
| Subject information and informed consent form (for publication) | L1_Patient ID Card_CZE_CS_for pub | 1.0.1.2 |
| Subject information and informed consent form (for publication) | L2_Patient compensation_Astrum_DEU_DE_SM12_for pub | 3.0R |
| Subject information and informed consent form (for publication) | L2_Patient dosing card_CZE_CS_SM08_for pub | 1R |
| Subject information and informed consent form (for publication) | L2_Patient ID Card_HUN_HU_SM12_for pub | 2.0 |
| Subject information and informed consent form (for publication) | L2_Patient instructions_CZE_CS_SM08_for pub | 1R |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC RSI_CAPECITABINE Glenmark Pharmaceuticals_SM11_for pub | 23OCT2024 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC RSI_LIPOSOMAL DOXORUBICIN Baxter_SM11_for pub | 04JAN2024 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC RSI_PACLITAXEL Hospira UK LTD_SM11_for pub | 27JUN2024 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_pembrolizumab_for pub | 24MAR2020 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Q and RSI_NAB-PACLITAXEL_for pub | 06Oct2021 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-504918-29_DEU_DE_AM01_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-504918-29_ESP_ES_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-504918-29_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-504918-29_FRA_FR_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-504918-29_GRC_EL_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-504918-29_HUN_HU_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-504918-29_IRL_EN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-504918-29_ITA_IT_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-504918-29_NLD_NL_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-504918-29_NOR_NN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-504918-29_POL_PL_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-504918-29_ROU_RO_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-504918-29_SWE_SV_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_BEL_DE_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_BEL_FR_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_BEL_NL_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_CZE_CS_2023-504918-29_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_2023-504918-29_CZE_CS_SM12_for pub | 3.0R |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_2023-504918-29_ROU_RO_SM12_for pub | 04R |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_PRT_PT_2023-504918-29_for pub | v00R |
Application history
17 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-30 | Denmark | Acceptable with conditions 2024-05-13
|
2024-05-13 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-12 | Denmark | Acceptable with conditions 2024-08-19
|
2024-08-19 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-08-27 | Acceptable with conditions | 2024-10-01 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-08-30 | Denmark | Acceptable with conditions | 2024-11-06 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-08-30 | Acceptable with conditions | 2024-10-18 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-09-04 | Acceptable with conditions | 2024-10-17 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-09-06 | Acceptable with conditions | 2024-10-22 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-09-23 | Acceptable with conditions | 2024-10-15 | |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-11-11 | Acceptable with conditions | 2024-11-11 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-8 | 2024-12-18 | Denmark | Acceptable 2025-03-21
|
2025-03-21 |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-04-07 | Denmark | Acceptable 2025-03-21
|
2025-04-07 |
| 12 | SUBSEQUENT ADDITION OF MSC | APP-12 | 2025-04-09 | Acceptable 2025-03-21
|
2025-06-25 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-04-09 | Acceptable | 2025-05-17 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-04-11 | Acceptable | 2025-05-27 | |
| 15 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-07-16 | Denmark | Acceptable 2025-09-09
|
2025-09-09 |
| 16 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-09-18 | Denmark | Acceptable 2025-09-09
|
2025-09-18 |
| 17 | SUBSTANTIAL MODIFICATION | SM-12 | 2025-10-10 | Denmark | Acceptable 2026-01-20
|
2026-01-20 |