Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
500
Countries
12
Sites
78
Treatment-Naïve Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
To compare anti-tumor activity
Key facts
- Sponsor
- Janssen Cilag International
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 21 Jan 2026 → ongoing
- Decision date (initial)
- 2026-01-18
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Safety, Efficacy
To compare anti-tumor activity
Secondary objectives 4
- 1. To further assess measures of clinical benefit
- 2. To assess safety and tolerability
- 3. To assess disease symptoms, HRQoL, and treatment tolerability
- 4. For amivantamab-treated participants only: To explore the relationship between PK or immunogenicity and selected endpoints in amivantamab-treated participants (including but not limited to efficacy and safety)
Conditions and MedDRA coding
Treatment-Naïve Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | LLT | 10082179 | Squamous cell carcinoma of head and neck metastatic | 10029104 |
| 27.0 | LLT | 10090001 | Squamous cell carcinoma of head and neck recurrent | 100000004864 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
- IPD plan description
- The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- 1. Have histologically or cytologically confirmed R/M HNSCC that is considered incurable by local therapies.
- 2. Be treatment-naïve for systemic therapy in the R/M setting.
- 3. 18 years and older with ECOG 0-1
- 4. Have measurable disease according to RECIST v1.1
Exclusion criteria 4
- 1. Uncontrolled illness
- 2. Has untreated brain metastases or history or known presence of leptomeningeal disease
- 3. Has a history of clinically significant cardiovascular disease
- 4. Inadequate organ or bone marrow function
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Overall Survival (OS)
Secondary endpoints 9
- 1. PFS (using RECIST v1.1), as assessed by BICR
- 2. ORR as assessed by BICR
- 3. DOR as assessed by BICR
- 4. ORR as assessed by the investigator
- 5. Incidence and severity of TEAEs and laboratory abnormalities
- 6. Proportion of participants with improved or stable symptoms relative to baseline, as measured by the EORTC QLQ-HN43 and symptom scales of the EORTC QLQ-C30
- 7. Change from baseline in functioning and overall HRQoL, as measured by functioning and global health scales of the EORTC QLQC30
- 8. Differences between treatment groups in the EORTC IL46 tolerabilityscale scores
- 9. Serum amivantamab concentrations and serum anti-amivantamab antibodies
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
PRD11078981 · Product
- Active substance
- Amivantamab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
SCP6094344 · ATC
- Active substance
- Pembrolizumab
- Substance synonyms
- Lambrolizumab, MK-3475, SCH-900475, BAT3306, Pabolizumab, FYB206, CT P51, SYS6036, QL-2107, ABP 234
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg/h milligram(s)/hour
- Max treatment duration
- 1 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF02 — PEMBROLIZUMAB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling
SCP10337134 · ATC
- Active substance
- Carboplatin
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling
Comparator 2
SCP1165178 · ATC
- Active substance
- Fluorouracil
- Substance synonyms
- 5-FLOUROURACIL, 5-FLUORO-1H-PYRIMIDINE-2,4-DIONE, 5-FLUOROURACIL, 5-FU
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BC02 — FLUOROURACIL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling
SCP134220 · ATC
- Active substance
- Cisplatin
- Substance synonyms
- Cis-diamminedichloroplatinum, (SP-4-2)-cis -diamminedichloroplatinum, CDDP
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Janssen Cilag International
- Sponsor organisation
- Janssen Cilag International
- Address
- Turnhoutseweg 30
- City
- Beerse
- Postcode
- 2340
- Country
- Belgium
Scientific contact point
- Organisation
- Janssen Cilag International
- Contact name
- CTIS Point of Contact
Public contact point
- Organisation
- Janssen Cilag International
- Contact name
- CTIS Point of Contact
Third parties 3
| Organisation | City, country | Duties |
|---|---|---|
| Bioclinica Inc. ORG-100033079
|
Princeton, United States | Other |
| Smithers PDS LLC ORG-100040403
|
Gaithersburg, United States | Other, Laboratory analysis |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | E-data capture |
Locations
12 EU/EEA countries · 78 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 12 | 5 |
| Belgium | Ongoing, recruiting | 14 | 5 |
| Czechia | Ongoing, recruiting | 14 | 6 |
| France | Ongoing, recruiting | 22 | 9 |
| Germany | Ongoing, recruiting | 22 | 9 |
| Hungary | Ongoing, recruiting | 14 | 6 |
| Italy | Ongoing, recruiting | 17 | 7 |
| Netherlands | Authorised, recruitment pending | 10 | 3 |
| Poland | Ongoing, recruiting | 15 | 6 |
| Portugal | Ongoing, recruiting | 15 | 6 |
| Romania | Ongoing, recruiting | 15 | 7 |
| Spain | Ongoing, recruiting | 22 | 9 |
| Rest of world
Mexico, Australia, China, United Kingdom, Japan, United States, India, Brazil, Korea, Republic of, Taiwan
|
— | 308 | — |
Investigational sites
Medizinische Universitaet Innsbruck
Innere Medizin V - Hämatologie und Onkologie, Anichstrasse 35, 6020, Innsbruck
Burgenlaendische Krankenanstalten GmbH
Krhs. Oberwart, Abteilung für Onkologie, Hämatologie und Palliativmedizin, Josef Hyrtl-Platz 4, 7000, Eisenstadt
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Uniklinikum Salzburg Landeskrankenhaus Klinik f. Innere Medizin III/ CRCS GmbH-M3 CTC, Muellner Hauptstrasse 48, 5020, Salzburg
Noe LGA Gesundheit Region Mitte GmbH
Universitätsklinikum St. Pölten - Klinische Abteilung für Innere Medizin, Dunant-Platz 1, 3100, St. Poelten
Medical University Of Vienna
Innere Medizin I - Hämatologie und Hämostaseologie, Waehringer Guertel 18-20, Alsergrund, Vienna
UZ Leuven
Oncology, Herestraat 49, 3000, Leuven
CHU Helora
Oncology, Rue Ferrer 159 Boite 1, 7100, La Louviere
Vitaz
Oncology, Moerlandstraat 1, 9100, Sint-Niklaas
Cliniques Universitaires Saint-Luc
Oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Universitair Ziekenhuis Antwerpen
Oncology, Drie Eikenstraat 655, 2650, Edegem
Fakultni Nemocnice Hradec Kralove
Klinika onkologie a radioterapie, Sokolska 581, Novy Hradec Kralove, Hradec Kralove
University Hospital Olomouc
Onkologicka klinika, Zdravotniku 248/7, 779 00, Olomouc
Fakultni Nemocnice Ostrava
Klinika onkologicka, 17. Listopadu 1790/5, Poruba, Ostrava
Krajska Nemocnice T Bati a.s.
Onkologicke oddeleni, Havlickovo Nabrezi 600, 760 01, Zlin
Fakultni Nemocnice Kralovske Vinohrady
Onkologicke klinika, Srobarova 1150/50, Vinohrady, Prague
Fakultni Nemocnice V Motole
Onkologicka klinika 2. LF a FN Motol, V Uvalu 84/1, Motol, Prague
Institut Curie
Clinical investigation Unit, 26 Rue D Ulm, 75005, Paris
Sainte Catherine Institut Du Cancer Avignon-Provence
Medical oncology, 250 Chemin De Baigne Pieds, 84918, Avignon Cedex 9
Institut De Cancerologie De L Ouest
Medical oncology, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Centre Oscar Lambret
Medical oncology, 3 Rue Frederic Combemale, 59000, Lille
Assistance Publique Hopitaux De Paris
Medical oncology, 4 Rue De La Chine, 75020, Paris
Clinique Victor Hugo
Oncology radiotherapy, Centre De Cancerologie De La Sarthe, 66 Rue De Degre, Le Mans
Centre Henri Becquerel
Medical oncology, Rue D Amiens, 76038, Rouen Cedex
Institut Gustave Roussy
Head and Neck department, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Hospitalier Regional De Marseille
Medical oncology, 144 Rue Saint Pierre, 13005, Marseille
Universitaetsklinikum Regensburg AöR
Klinik und Poliklinik für Innere Medizin II, Franz-Josef-Strauss-Allee 11, Grass-Oberisling, Regensburg
Universitaetsklinikum Bonn AöR
Medizinische Klinik und Poliklinik III - Innere Medizin, Venusberg-Campus 1, Venusberg, Bonn
Universitaetsklinikum Ulm AöR
Klinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie, Frauensteige 12, Mitte, Ulm
Klinikum Region Hannover GmbH
KRH Klinikum Siloah - Klinik für Hämatologie, Onkologie und Immunologie, Stadionbruecke 4, Linden-Sued, Hanover
Universitaetsklinikum Essen AöR
Westdeutsches Tumorzentrum - Innere Klinik (Tumorforschung), Hufelandstrasse 55, Holsterhausen, Essen
Rostock University Medical Center
Zentrum für Innere Mediziin, Abt. für Onkologie/Hämatologie/Palliativmedizin, Ernst-Heydemann-Strasse 6, Hansaviertel, Rostock
Goethe University Frankfurt
Universitätsklinikum Frankfurt, Medizinische Klinik II, Hämatologie/Onkologie, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Justus-Liebig-Universitaet Giessen
Universitaetsklinikum Giessen und Marburg GmbH, Hals-Nasen-Ohren Klinik, Klinikstrasse 33, 35392, Giessen
Universitaet Leipzig
Universitätsmedizin Leipzig AöR, Klinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde, Liebigstrasse 12, Zentrum-Suedost, Leipzig
Orszagos Onkologiai Intezet
Oncology, Rath Gyorgy Utca 7-9, Kerulet, Budapest XII
University Of Pecs
Oncology, Edesanyak Utja 17, 7624, Pecs
Nograd Varmegyei Szent Lazar Korhaz
Oncology, Fuleki Ut 54-56, 3100, Salgotarjan
University Of Debrecen
Oncology, Nagyerdei Korut 98, 4032, Debrecen
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Oncology, Vasvari Pal Utca 2-4, 9024, Gyor
Semmelweis University
Department of Otorhinolaryngology, Head and Neck Surgery, Szigony Utca 36, 1083, Budapest Viii
Fondazione IRCCS Istituto Nazionale Dei Tumori
S.C. Oncologia Medica 3 - Tumori testa-collo, Via Giacomo Venezian 1, 20133, Milan
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Muscle scheletrical and head and neck, Via Mariano Semmola 52, 80131, Naples
Humanitas Mirasole S.p.A.
Head and neck and non-melanoma skin cancer Oncology, Via Alessandro Manzoni 56, 20089, Rozzano
Fondazione IRCCS Policlinico San Matteo
SC Oncologia, Viale Camillo Golgi 19, 27100, Pavia
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
UO Oncologia Medica, Via Del Vespro 129, 90127, Palermo
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department of radiological, oncological and anatomopathological sciences-Oncologia A, Viale Del Policlinico 155, 00161, Rome
Istituto Europeo Di Oncologia S.r.l.
Divisione di Oncologia Medica Urogenitale e Cervico facciale, Via Giuseppe Ripamonti 435, 20141, Milan
Academisch Ziekenhuis Maastricht
Oncology, P Debyelaan 25, 6229 HX, Maastricht
Amsterdam UMC Stichting
Oncology, De Boelelaan 1117, 1081 HV, Amsterdam
Universitair Medisch Centrum Groningen
Oncology, Hanzeplein 1, 9713 GZ, Groningen
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Centrum Wsparcia Badan Klinicznych, Ul. Wybrzeze Armii Krajowej 15, 44-102, Gliwice
Wielkopolskie Centrum Onkologii Im. Marii Sklodowskiej-Curie
Oddzial Onkologii Klinicznej i Immunoonkologii z Pododdzialem Dziennym i Izba Przyjec, Ul. Garbary 15, 61-866, Poznan
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Kilinka Nowotworow Glowy I Szyi, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Uniwersyteckie Centrum Kliniczne
Klinika Onkologii i Radioterapii, Ul. Debinki 7, 80-952, Gdansk
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
II Oddzial Onkologii i Immunologii Klinicznej z Chemioterapia Dzienna, Ul. Dra Kazimierza Jaczewskiego 7, 20-090, Lublin
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Oddzial Chorob Rozrostowych, Ul. Pabianicka 62, 93-513, Lodz
Instituto Portugues De Oncologia De Coimbra Francisco Gentil E.P.E.
Medical Oncology, Avenida Doutor Bissaya Barreto 98, 3000-075, Coimbra
Hospital Cuf Descobertas S.A.
Oncology, Rua Mario Botas 1, 1998-018, Lisbon
Unidade Local De Saude De Gaia/Espinho E.P.E.
Medical Oncology, Rua Conceicao Fernandes S/n, 4434-502, Vila Nova De Gaia
Unidade Local de Saude do Algarve E.P.E.
Oncology, Sitio Do Poco Seco, 8500-338, Portimao
Unidade Local De Saude De Santa Maria E.P.E.
Medical Oncology, Avenida Professor Egas Moniz, 1649-035, Lisbon
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Medical Oncology, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
Institutul Regional De Oncologie Iasi
Oncologie, Strada Sararie 177b, 700451, Iasi
Spitalul Clinic Coltea
Oncologie, Bulevardul Bratianu C. Ion 1-3, 030171, Bucharest
Oncocenter Oncologie Clinica S.R.L.
Oncologie, Strada Garii 1a, 300166, Timisoara
Centrul De Oncologie SF Nectarie S.R.L.
Oncologie, Strada Caracal Nr 109, 200542, Craiova
Cardiomed S.R.L.
Oncologie, Strada Republicii Nr 30, 400015, Cluj-Napoca
Institutul Regional De Oncologie Iasi
Oncologie, Strada G-Ral Berthelot 2-4, 700483, Iasi
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Oncologie, Strada Republicii 34-36, 400015, Cluj-Napoca
Hospital Universitario Miguel Servet
Oncology, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
Institut Catala D'oncologia
Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Clinico San Carlos
Oncology, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Consorcio Hospital General Universitario De Valencia
Oncology, Avenida Tres Cruces 2, 46014, Valencia
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital General Universitario Gregorio Maranon
Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitario De Navarra
Oncology, Irunlarrea Kalea 3, 31008, Pamplona
Hospital Universitario 12 De Octubre
Oncology, Avenida De Cordoba Sn, 28041, Madrid
Fundacion Publica Galega Instituto De Investigacion Sanitaria De Santiago De Compostela
Oncology, Travesia Da Choupana S/N, 15706, Santiago De Compostela
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 | 2026-04-14 | 2026-04-14 | |||
| Belgium | 2026-03-11 | 2026-03-11 | |||
| Czechia | 2026-01-26 | 2026-01-26 | |||
| France | 2026-02-12 | 2026-02-12 | |||
| Germany | 2026-03-19 | 2026-03-19 | |||
| Hungary | 2026-04-07 | 2026-04-07 | |||
| Italy | 2026-02-23 | 2026-02-23 | |||
| Poland | 2026-01-21 | 2026-01-21 | |||
| Portugal | 2026-03-18 | 2026-03-18 | |||
| Romania | 2026-02-10 | 2026-02-10 | |||
| Spain | 2026-02-05 | 2026-02-05 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 121 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | REDACTED_D1_Protocol_2025-521917-24 | Am EEA1 |
| Protocol (for publication) | REDACTED_D4_PF EQ-5D-5L inter_multicountry_multilingual_2025-521917-24 | 1 |
| Protocol (for publication) | REDACTED_D4_PF EQ-5D-5L_multicountry_multilingual_2025-521917-24 | 1 |
| Protocol (for publication) | REDACTED_D4_PF IL46 script_multicountry_multilingual_2025-521917-24 | 1 |
| Protocol (for publication) | REDACTED_D4_PF IL46_multicountry_multilingual_2025-521917-24 | 1 |
| Protocol (for publication) | REDACTED_D4_PF QLQ-C30 script_multicountry_multilingual_2025-521917-24 | 1 |
| Protocol (for publication) | REDACTED_D4_PF QLQ-C30_multicountry_multilingual_2025-521917-24 | 1 |
| Protocol (for publication) | REDACTED_D4_PF QLQ-HN43 script_multicountry_multilingual_2025-521917-24 | 1 |
| Protocol (for publication) | REDACTED_D4_PF QLQ-HN43_multicountry_multilingual_2025-521917-24 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangement_ES_eng_2025-521917-24 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements _PT_ENG_2025-521917-24 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_AT_ENG_2025-521917-24 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_BE_Eng_2025-521917-24 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_CZ_cze_2025-521917-24 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_DE_ENG_2025-521917-24 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_FR_fre_2025-521917-24 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_IT_ENG_2025-521917-24 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment arrangements_NL_Eng_2025-521917-24 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_PL_POL_2025-521917-24 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_RO_ENG_2025-521917-24 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Material FAQ Document_DE_GER_2025-521917-24 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material Advertisement_BE_Dut_2025-521917-24 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material Advertisement_BE_Fre_2025-521917-24 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material Advertisement_HU_HUN_2025-521917-24 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Advertisement_NL_Dut_2025-521917-24 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Common Study Questions_IT_ITA_2025-521917-24 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Common Study Questions_PT_POR_2025-521917-24 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Common Study Questions_RO_RUM_2025-521917-24 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material FAQ Document_AT_GER_2025-521917-24 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material FAQ_PL_POL_2025-521917-24 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_Common Study Questions_CZ_cze_2025-521917-24 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_Common Study Questions_ES_SPA_2025-521917-24 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_Common Study Questions_FR_fre_2025-521917-24 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF _Pregnancy_ICF_DE_GER_2025-521917-24 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF _Withdrawal_ICF_DE_GER_2025-521917-24 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF After Disease Progression Treatment_CZ_cze_2025-521917-24 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical _HU_HUN_2025-521917-24 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_CZ_cze_2025-521917-24 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_ES_SPA_2025-521917-24 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_FR_FRE_2025-521917-24 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_ICF_Add_Treat_Beyond_Progr-AUT_GER_2025-521917-24 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_ICF_Add_Treat_Beyond_Progression_DE_GER_2025-521917-24 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_IT_ITA_2025-521917-24 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_Main_ICF-AUT_GER_2025-521917-24 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_Main_ICF-DE_GER_2025-521917-24 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_PL_POL_2025-521917-24 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_Pregnancy_ICF-AUT_GER_2025-521917-24 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_PT_POR_2025-521917-24 | 6 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_RO_RUM_2025-521917-24 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Continuation After DP_PT_POR_2025-521917-24 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Genetic_HU_HUN_2025-521917-24 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_BE_Dut_2025-521917-24 | 1.2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_BE_Fre_2025-521917-24 | 1.2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_NL_Dut_2025-521917-24 | 1.2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Patient Travel Reimbursement_IT_ITA_2025-521917-24 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Post-Disease Progression Treatment_IT_ITA_2025-521917-24 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnancy_BE_Dut_2025-521917-24 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnancy_BE_Fre_2025-521917-24 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnancy_NL_Dut_2025-521917-24 | 1.1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnancy_PL_POL_2025-521917-24 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnancy_PT_POR_2025-521917-24 | 5 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnancy_RO_RUM_2025-521917-24 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Participant_ICF_DE_GER_2025-521917-24 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_CZ_cze_2025-521917-24 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_HU_HUN_2025-521917-24 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_IT_ITA_2025-521917-24 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy Clinical_IT_ITA_2025-521917-24 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy Family_IT_ITA_2025-521917-24 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy Language_CZ_cze_2025-521917-24 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy Pregnant Partner_IT_ITA_2025-521917-24 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Sponsor Statement_BE_Eng_2025-521917-24 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF STADP_BE_Dut_2025-521917-24 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF STADP_BE_Fre_2025-521917-24 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF STADP_NL_Dut_2025-521917-24 | 1.1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Treatment after progression_Addendum 1_HU_HUN_2025-521917-24 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Treatment Beyond PD ICF Addendum_RO_RUM_2025-521917-24 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Treatment continuation_PL_POL_2025-521917-24 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal Informed Consent_AUT_GER_2025-521917-24 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_CZ_cze_2025-521917-24 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_ES_SPA_2025-521917-24 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_HU_HUN_2025-521917-24 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_IT_ITA_2025-521917-24 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_PL_POL_2025-521917-24 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_PT_POR_2025-521917-24 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_RO_RUM_2025-521917-24 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_After Disease Progression_FR_FRE_2025-521917-24 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Holder of Parental Authority_FR_FRE_2025-521917-24 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_ICF Contact Data Sheet_AT_ENG_2025-521917-24 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Pregnant Participant_FR_FRE_2025-521917-24 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Pregnant Partner of Participant_FR_FRE_2025-521917-24 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Privacy Child Exposed to IP_IT_ITA_2025-521917-24 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Withdrawal_FR_FRE_2025-521917-24 | 1 |
| Subject information and informed consent form (for publication) | Redacted_L2_Subject Wallet Card_AT_GER_2025-521917-24 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_CZ_cze_2025-521917-24 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_DE_GER_2025-521917-24 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_ES_SPA_2025-521917-24 | 7 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_FR_FRE_2025-521917-24 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_HU_HUN_2025-521917-24 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_IT_ITA_2025-521917-24 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_PL_POL_2025-521917-24 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_PT_POR_2025-521917-24 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_RO_RUM_2025-521917-24 | 1 |
| Subject information and informed consent form (for publication) | REDCATED_L1_SIS and ICF Add Post-Disease Progression Treatment__ES_SPA_2025-521917-24 | 1 |
| Subject information and informed consent form (for publication) | REDCATED_L1_SIS and ICF Pregnant Partner_ES_SPA_2025-521917-24 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Carboplatin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Cisplatin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Fluorouracil | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Pembrolizumab | 1 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_AT_GER_2025-521917-24 | AmEEA-1 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol synopsis_BE_Dut_2025-521917-24 | Am EEA1 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol synopsis_BE_Fre_2025-521917-24 | Am EEA1 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol synopsis_BE_Ger_2025-521917-24 | Am EEA1 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_CZ_cze_2025-521917-24 | Am EEA-1 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_ES_SPA_2025-521917-24 | AM EEA1 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_FR_FRE_2025-521917-24 | AM EEA1 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_HU_HUN_2025-521917-24 | AmEEA-1 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol synopsis_IT_ITA_2025-521917-24 | AM EEA-1 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol synopsis_NL_Dut_2025-521917-24 | Am EEA1 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_PL_POL_2025-521917-24 | Am EEA-1 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_PT_POR_2025-521917-24 | AmEEA-1 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_RO_RUM_2025-521917-24 | Am EEA-1 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-04 | Portugal | Acceptable 2026-01-14
|
2026-01-14 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-01-20 | Acceptable | 2026-02-02 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-01-20 | Portugal | Acceptable | 2026-02-02 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-01-27 | Acceptable | 2026-02-25 |