Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
343
Countries
8
Sites
39
Resected Melanoma Stage III or Stage IV
Key facts
- Sponsor
- Amgen Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 1 Aug 2023 → 31 Oct 2025
- Decision date (initial)
- 2023-06-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-502620-49-00
- WHO UTN
- U1111-1287-1294
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Resected Melanoma Stage III or Stage IV
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10025671 | Malignant melanoma stage IV | 100000004864 |
| 21.1 | PT | 10025670 | Malignant melanoma stage III | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amgen Inc.
- Sponsor organisation
- Amgen Inc.
- Address
- 1 Amgen Center Drive
- City
- Thousand Oaks
- Postcode
- 91320-1799
- Country
- United States
Scientific contact point
- Organisation
- Amgen Inc.
- Contact name
- Medical Information
Public contact point
- Organisation
- Amgen Inc.
- Contact name
- Medical Information
Locations
8 EU/EEA countries · 39 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Croatia | Ended | 6 | 2 |
| France | Ended | 17 | 6 |
| Germany | Ended | 46 | 5 |
| Italy | Ended | 36 | 12 |
| Lithuania | Ended | 10 | 1 |
| Netherlands | Ended | 7 | 1 |
| Romania | Ended | 12 | 2 |
| Spain | Ended | 22 | 10 |
| Rest of world
Japan, Vietnam, Taiwan, Thailand, Argentina, Mexico, Serbia, United States, Chile, Moldova, Republic of, Malaysia, Brazil, Bosnia and Herzegovina, South Africa, Georgia, Korea, Republic of
|
— | 187 | — |
Investigational sites
University Hospital Centre Zagreb
98320002:Oncology department, Ulica Mije Kispatica 12, Zagreb, Grad Zagreb
Klinicki bolnicki centar Sestre milosrdnice
98320003:Oncology department, Vinogradska Cesta 29, Zagreb, Grad Zagreb
Centre Hospitalier Universitaire De Lille
#98325003:Clinique de Dermatologie, Rue Michel Polonovski, 59037, Lille Cedex
Hopital Ambroise Pare
#98325005:Dermatologie, 9 Avenue Charles De Gaulle, 92100, Boulogne-Billancourt
Centr Georges Francois Leclerc
#98325006:service d'oncologie médicale, 1 Rue Professeur Marion, 21000, Dijon
CHU De Bordeauxt
#98325007: Dermatologie, 1 Rue Jean Burguet, Cs 11261, Bordeaux Cedex
Centre Hospitalier Universitaire De Dijon
#98325004:Service de Dermatologie, 14 Rue Paul Gaffarel, 21000, Dijon
Centre Hospitalier Universitaire De Poitiers
#98325001:Oncologie Medicale, 2 Rue De La Miletrie, 86000, Poitiers
University Hospital Cologne AöR
98326006: Dermatologie und Venerologie Hauttumorzentrum, Kerpener Strasse 62, Lindenthal, Cologne
Charite Universitaetsmedizin Berlin KöR
98326002: Clinical Research Center Dermatology (CRCD) Dermatoonkologie, Charitéplatz 1, Mitte, Berlin
Srh Wald-Klinikum Gera GmbH
98326005: Zentrum für klinische Studien, Strasse Des Friedens 122, Debschwitz, Gera
University Medical Center Hamburg-Eppendorf
98326003: Klinik und Poliklinik für Dermatologie und Venerologie Hauttumorzentrum, Martinistrasse 52, Eppendorf, Hamburg
Goethe University Frankfurt
98326001: Dermatology, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Istituto Tumori Bari Giovanni Paolo II
#98333009:UO Oncologia Medica UOS Tumori Rari Melanoma, Viale Orazio Flacco 65, 70124, Bari
Fondazione Luigi Maria Monti
#98333014:UO Oncologia, Roma, Via Dei Monti Di Creta 104, Rome
Fondazione IRCCS Policlinico San Matteo
#98333017:SC Oncologia, Dipartimento di Oncologia, Viale Camillo Golgi 19, 27100, Pavia
Azienda Ospedaliera Ospedale Di Circolo E Fondazione Macchi
#98333016:SC Oncologia, Viale Luigi Borri 57, 21100, Varese
Azienda Ospedaliera Papa Giovanni XXIII
#98333013:UOC Oncologia, Piazza Oms 1, 24127, Bergamo
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.R.L.
#98333012:Oncologia Medica, Via Piero Maroncelli 40, 47014, Meldola
Azienda Ospedaliera Universitaria Federico II Di Napoli
#98333006:UOC Oncologia Medica, Via Sergio Pansini 5, 80131, Naples
Azienda Ospedaliera Universitaria Senese
#98333002:Immunoterapia Oncologica, Strada Delle Scotte 14, 53100, Siena
European Institute Of Oncology S.r.l.
#98333015:Oncologia Medica del Melanoma e Sarcomi, Via Giuseppe Ripamonti 435, 20141, Milan
Azienda Ospedaliero Universitaria Delle Marche
#98333018:SOD Oncologia Medica, Via Conca 71, 60126, Ancona
Fondazione Policlinico Universitario Campus Bio-Medico
#98333008:Oncologia Medica, Via Alvaro Del Portillo N 200, 00128, Rome
Ospedale San Raffaele S.r.l.
#98333003:UOC Oncologia Medica, Via Olgettina 60, 20132, Milan
Amphia Hospital
98342001: Medical Oncology, Molengracht 21, 4818 CK, Breda
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
#98350011: Oncology, Soseaua Fundeni 252, 022328, Bucharest
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
#98350010:Oncology, Strada Republicii 34-36, 400015, Cluj-Napoca
Catalan Institute Of Oncology
#98358006: Oncology, Carretera Canyet S/n, 08916, Badalona
Hospital Universitario Virgen De La Macarena
#98358010: Oncology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Universitari Vall D Hebron
#98358008: Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital General Universitario De Valencia
#98358007: Oncology, Avenida Del Tres Cruces S/n, 46014, Valencia
Hospital De La Santa Creu I Sant Pau
#98358001: Oncology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
MD Anderson Cancer Center
#98358011: Oncology, Calle De Arturo Soria Nº 270, 28033, Madrid
Hospital San Pedro De Alcantara
#98358004: Oncology, Avenida De Pablo Naranjo Porras S/n, 10002, Caceres
Hospital Clinic De Barcelona
#98358002: Dermatology, Calle Villarroel 170, 08036, Barcelona
University Clinical Hospital Virgen De La Arrixaca
#98358009: Oncology, Carretera De Cartagena S/n, El Palmar, Murcia
Hospital Jerez Puerta Del Sur Grupo Hla S.A.
#98358005: Oncology, Avenida De La Puerta Del Sur Sn, 11408, Jerez De La Frontera
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 |
|---|---|---|---|---|---|
| Croatia | 2023-11-08 | 2025-07-29 | 2023-11-08 | 2024-10-11 | |
| Italy | 2023-08-28 | 2025-07-14 | 2023-08-28 | 2024-10-11 | |
| Lithuania | 2023-12-13 | 2025-08-29 | 2023-12-13 | 2024-10-11 | |
| Netherlands | 2024-03-18 | 2025-04-30 | 2024-03-18 | 2024-10-11 | |
| Romania | 2024-01-29 | 2025-09-29 | 2024-01-29 | 2024-10-11 | |
| Spain | 2023-08-01 | 2025-10-29 | 2023-08-01 | 2024-10-11 |
Application history
12 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-02-23 | Germany | Acceptable 2023-06-19
|
2023-06-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-06-30 | Germany | Acceptable | 2023-08-18 |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2023-07-04 | Acceptable 2023-06-19
|
2023-09-12 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-07-10 | Acceptable | 2023-09-05 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2023-07-10 | Acceptable | 2023-08-02 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-07-12 | Acceptable | 2023-07-26 | |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-09-12 | Acceptable | 2023-09-12 | |
| 8 | SUBSEQUENT ADDITION OF MSC | APP-8 | 2023-09-20 | Acceptable 2023-06-19
|
2023-12-18 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-05-15 | Germany | Acceptable 2024-08-26
|
2024-08-26 |
| 10 | SUBSTANTIAL MODIFICATION | SM-8 | 2024-10-09 | Acceptable | 2024-12-02 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-02-28 | Acceptable 2025-05-05
|
2025-05-06 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-09-12 | Acceptable 2025-11-17
|
2025-11-21 |