Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
813
Countries
11
Sites
57
Advanced (unresectable/metastatic) melanoma
Key facts
- Sponsor
- H e x a l AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 28 Mar 2025 → 23 Jan 2026
- Decision date (initial)
- 2024-07-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507865-24-00
- ClinicalTrials.gov
- NCT06587451
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced (unresectable/metastatic) melanoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10027480 | Metastatic malignant melanoma | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
H e x a l AG
- Sponsor organisation
- H e x a l AG
- Address
- Industriestrasse 25
- City
- Holzkirchen
- Postcode
- 83607
- Country
- Germany
Scientific contact point
- Organisation
- H e x a l AG
- Contact name
- Biosimilar Clinical Trials Information Point
Public contact point
- Organisation
- H e x a l AG
- Contact name
- Biosimilar Clinical Trials Information Point
Locations
11 EU/EEA countries · 57 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ended | 12 | 2 |
| Czechia | Ended | 12 | 3 |
| Germany | Ended | 39 | 5 |
| Greece | Ended | 22 | 2 |
| Hungary | Ended | 9 | 1 |
| Italy | Ended | 76 | 11 |
| Lithuania | Ended | 9 | 3 |
| Poland | Ended | 14 | 3 |
| Portugal | Ended | 13 | 4 |
| Romania | Ended | 38 | 9 |
| Spain | Ended | 58 | 14 |
| Rest of world
Philippines, Georgia, Korea, Republic of, Malaysia, United States, Argentina, Mexico, Serbia, Colombia, Thailand, Peru, South Africa, Chile, Brazil, Taiwan, Turkey
|
— | 511 | — |
Investigational sites
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
Clinic of Medical Oncology, Oborishte Distr., Ul.Byalo More 8, Sofia
National Oncological Medical Center EOOD
N/A, Ulitsa Plovdivsko Pole 6, 1756, Sofia
Nemocnice AGEL Novy Jicin a.s.
Oddělení radioterapie, Purkynova 2138/16, 741 01, Novy Jicin
Kožní ordinace
N/A, Bolzanova 1604/7, 110 00, Praha 1
Fakultni Nemocnice Hradec Kralove
Klinika onkologie a radioterapie, Sokolska 581, 500 03, Novy Hradec Kralove
Universitaetsklinikum Duesseldorf AöR
Klinik fuer Dermatologie, Moorenstrasse 5, Bilk, Duesseldorf
University Hospital Cologne AöR
Klinik und Poliklinik fuer Dermatologie und Venerologie, Kerpener Strasse 62, Lindenthal, Cologne
SRH Wald-Klinikum Gera GmbH
Zentrum für klinische Studien, Strasse Des Friedens 122, Debschwitz, Gera
Deutsches Rotes Kreuz Gemeinnuetzige Krankenhaus Sachsen GmbH
Klinik fuer Dermatologie, Unritzstrasse 23, Rabenstein, Chemnitz
Justus-Liebig-Universitaet Giessen
Klinik fuer Dermatologie und Allergologie, Gaffkystrasse 14, 35392, Giessen
Metropolitan Hospital
A' Oncology Clinic, Ethnarchi Makariou 11, 185 47, Pireas
Athens Medical Center S.A.
Oncology Department, Pylea, Asklipiou 10, Thessaloniki
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Onkoradiologiai Osztaly, Vasvari Pal Utca 2-4, 9024, Gyor
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Dermatology Unit, Via Cherasco 15, 10126, Turin
Azienda Ospedaliero Universitaria Pisana
U.O. Oncologia Medica Universitaria, Via Roma 67, 56126, Pisa
Humanitas Research Hospital
Oncology Unit, Via Alessandro Manzoni 56, 20089, Rozzano
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Uro-Gynecological Pathology, Via Piero Maroncelli 40, 47014, Meldola
Azienda Ospedaliera Universitaria Senese
Division of Medical Oncology and Immunology, Strada Delle Scotte 14, 53100, Siena
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
U.O.C. Oncologia Medica ed Ematologia, Dipartimento di Medicina di Precisione, Via Sergio Pansini 5, 80131, Naples
Istituto Tumori Bari Giovanni Paolo II
UO Medical Oncology, Viale Orazio Flacco 65, 70124, Bari
Universita' Degli Studi G. D'annunzio Di Chieti
UOC Clinica Oncologica, Via Dei Vestini 31, 66100, Chieti
Azienda Ospedaliero Universitaria Di Modena
Divisione di Oncologia ed Ematologia, Largo Del Pozzo 71, 41124, Modena
Fondazione Luigi Maria Monti
Oncologia, Linfedema/Flebo-linfedema, Roma, Via Dei Monti Di Creta 104, Rome
Azienda Unita Sanitaria Locale Della Romagna
Oncology Unit, Viale Vincenzo Randi 5, 48121, Ravenna
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Clinic of skin and venereal diseases, Eiveniu G. 2, Kauno M. Sav., Kaunas
Nacionalinis vezio institutas
Department of Chemotherapy, Santariskiu G. 1, Vilniaus M. Sav., Vilnius
Klaipedos universiteto ligonine VšĮ
Oncology Chemotherapy department, Liepojos G. 41, Klaipedos M. Sav., Klaipeda
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Ambulatorium Chemioterapii, Ul. Izabeli Romanowskiej 2, 85-796, Bydgoszcz
Niepubliczny Zakład Opieki Zdrowotnej Zespół Poradni Specjalistycznych "Termedica"
N/A, os. Bolesława Chrobrego 101, 60-681, Poznań
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
First dep Klinika Nowotworów Tkanek Miękkich Kości i Czerniaków Sec. dep Oddzial Badań Wczesnych Faz, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Medical Oncology, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
Unidade Local De Saude De Almada-Seixal E.P.E.
Oncology, Avenida Torrado Da Silva, 2805-267, Almada
Unidade Local De Saude De Coimbra E.P.E.
Medical Oncology, Praceta Professor Mota Pinto, 3004-561, Coimbra
Hospital Cuf Tejo S.A.
Medical Oncology, Avenida 24 De Julho 171a, 1350-345, Lisbon
Spitalul Clinic Coltea
Departament Clinic Oncologie Medicala, Bulevardul Bratianu C. Ion 1-3, 030171, Bucharest
Mnt Healthcare Europe S.R.L.
Departament Clinic Oncologie Medicala, Strada Gradinarilor No 1, 077145, Pantelimon
Medisprof S.R.L.
Departament Clinic Oncologie Medicala, Bulevardul Muncii 96, 400641, Cluj-Napoca
Centrul De Oncologie SF Nectarie S.R.L.
Departament Clinic Oncologie Medicala, Strada Caracal Nr 109, 200542, Craiova
Radiotherapy Center Cluj S.R.L.
Departament Clinic Oncologie Medicala, Str. Razoare Nr. 486g Jud. Cluj, 407280, Floresti
Memorial Healthcare International S.R.L.
Departament Clinic Oncologie Medicala, Soseaua Ionescu-Sisesti Gheorghe Nr 8a, 013823, Bucharest
Gral Medical S.R.L.
Departament Clinic Oncologie Medicala, Strada Popovici Traian 79-91, 031422, Bucharest
Spitalul Clinic Judetean De Urgenta Cluj
Departament Clinic Oncologie Medicala, Strada Clinicilor 3-5, 400006, Cluj-Napoca
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Departament Clinic Oncologie Medicala II, Soseaua Fundeni 252, 022328, Bucharest
Hospital Universitario 12 De Octubre
Medical Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario Dr Peset Aleixandre
Medical Oncology, Avinguda De Gaspar Aguilar 90, 46017, Valencia
Hospital Universitario Regional De Malaga
Medical Oncology, Avenida De Carlos De Haya Sn, 29010, Malaga
Hospital Beata Maria Ana
Medical Oncology, Calle Del Doctor Esquerdo No. 83, 28007, Madrid
Hospital Universitario Central De Asturias
Medical Oncology, Avenida De Roma S/n, 33011, Oviedo
Hospital General Universitario Reina Sofia
Medical Oncology, Avenida Menendez Pidal S/n, 14004, Cordoba
Institut Catala D'oncologia
Medical Oncology, Carretera Canyet S/n, 08916, Badalona
Hospital Clinico Universitario De Valencia
Medical Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Complexo Hospitalario Universitario De Santiago
Medical Oncology, Calle Choupana Da S/n, 15706, Santiago De Compostela
MD Anderson Cancer Center
Medical Oncology, Calle De Arturo Soria Nº 270, 28033, Madrid
University Hospital Of Canary Islands
Medical Oncology, Carretera De La Cuesta Taco S/n, Cuesta La, San Cristobal De La Laguna
Hospital Universitario Marques De Valdecilla
Medical Oncology, Avenida Valdecilla Sn, 39008, Santander
H.C. Hospitales S.L.
Medical Oncology, Urb. Las Mimosas, Calle Santa Isabel S/N, Marbella
Hospital Universitario Y Politecnico La Fe
Medical Oncology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
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 |
|---|---|---|---|---|---|
| Greece | 2025-04-09 | 2025-04-09 | 2025-07-10 | ||
| Italy | 2025-03-28 | 2025-03-28 | 2025-07-10 | ||
| Lithuania | 2025-05-13 | 2025-05-13 | 2025-07-10 | ||
| Poland | 2025-06-13 | 2025-06-13 | 2025-07-10 | ||
| Portugal | 2025-06-02 | 2025-06-02 | 2025-07-10 | ||
| Romania | 2025-06-12 | 2025-06-12 | 2025-07-10 | ||
| Spain | 2025-04-23 | 2025-04-23 | 2025-07-10 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 7 · Art. 38 CTR
Temporary halt TH-91514
- Halt date
- 2025-07-10
- Member states concerned
- Portugal
- Publication date
- 2025-07-23
- Reason
- Sponsor decision
- Explanation
- In light of the evolving regulatory landscape and project specific feedback, which indicate that major Health Authorities (including the EMA) are moving towards a streamlined biosimilar clinical development, without comparative efficacy studies, Sandoz took a strategic decision and is winding down its CJPB898A12301 clinical study.
- Follow-up measures
- All patients currently in screening or randomized will complete the induction phase with the combination treatment of nivolumab plus ipilimumab within the study. Subsequently, Sandoz will ensure that patients will continue to receive treatment with nivolumab in the maintenance phase for up to one year. In countries/sites where no patients are currently enrolled, the study will be terminated.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-91513
- Halt date
- 2025-07-10
- Member states concerned
- Poland
- Publication date
- 2025-07-23
- Reason
- Sponsor decision
- Explanation
- In light of the evolving regulatory landscape and project specific feedback, which indicate that major Health Authorities (including the EMA) are moving towards a streamlined biosimilar clinical development, without comparative efficacy studies, Sandoz took a strategic decision and is winding down its CJPB898A12301 clinical study.
- Follow-up measures
- All patients currently in screening or randomized will complete the induction phase with the combination treatment of nivolumab plus ipilimumab within the study. Subsequently, Sandoz will ensure that patients will continue to receive treatment with nivolumab in the maintenance phase for up to one year. In countries/sites where no patients are currently enrolled, the study will be terminated.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-91512
- Halt date
- 2025-07-10
- Member states concerned
- Lithuania
- Publication date
- 2025-07-23
- Reason
- Sponsor decision
- Explanation
- In light of the evolving regulatory landscape and project specific feedback, which indicate that major Health Authorities (including the EMA) are moving towards a streamlined biosimilar clinical development, without comparative efficacy studies, Sandoz took a strategic decision and is winding down its CJPB898A12301 clinical study.
- Follow-up measures
- All patients currently in screening or randomized will complete the induction phase with the combination treatment of nivolumab plus ipilimumab within the study. Subsequently, Sandoz will ensure that patients will continue to receive treatment with nivolumab in the maintenance phase for up to one year. In countries/sites where no patients are currently enrolled, the study will be terminated.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-91511
- Halt date
- 2025-07-10
- Member states concerned
- Italy
- Publication date
- 2025-07-23
- Reason
- Sponsor decision
- Explanation
- In light of the evolving regulatory landscape and project specific feedback, which indicate that major Health Authorities (including the EMA) are moving towards a streamlined biosimilar clinical development, without comparative efficacy studies, Sandoz took a strategic decision and is winding down its CJPB898A12301 clinical study.
- Follow-up measures
- All patients currently in screening or randomized will complete the induction phase with the combination treatment of nivolumab plus ipilimumab within the study. Subsequently, Sandoz will ensure that patients will continue to receive treatment with nivolumab in the maintenance phase for up to one year. In countries/sites where no patients are currently enrolled, the study will be terminated.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-91510
- Halt date
- 2025-07-10
- Member states concerned
- Greece
- Publication date
- 2025-07-23
- Reason
- Sponsor decision
- Explanation
- In light of the evolving regulatory landscape and project specific feedback, which indicate that major Health Authorities (including the EMA) are moving towards a streamlined biosimilar clinical development, without comparative efficacy studies, Sandoz took a strategic decision and is winding down its CJPB898A12301 clinical study.
- Follow-up measures
- All patients currently in screening or randomized will complete the induction phase with the combination treatment of nivolumab plus ipilimumab within the study. Subsequently, Sandoz will ensure that patients will continue to receive treatment with nivolumab in the maintenance phase for up to one year. In countries/sites where no patients are currently enrolled, the study will be terminated.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-91507
- Halt date
- 2025-07-10
- Member states concerned
- Spain
- Publication date
- 2025-07-23
- Reason
- Sponsor decision
- Explanation
- In light of the evolving regulatory landscape and project specific feedback, which indicate that major Health Authorities (including the EMA) are moving towards a streamlined biosimilar clinical development, without comparative efficacy studies, Sandoz took a strategic decision and is winding down its CJPB898A12301 clinical study.
- Follow-up measures
- All patients currently in screening or randomized will complete the induction phase with the combination treatment of nivolumab plus ipilimumab within the study. Subsequently, Sandoz will ensure that patients will continue to receive treatment with nivolumab in the maintenance phase for up to one year. In countries/sites where no patients are currently enrolled, the study will be terminated.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-91515
- Halt date
- 2025-07-10
- Member states concerned
- Romania
- Publication date
- 2025-07-23
- Reason
- Sponsor decision
- Explanation
- In light of the evolving regulatory landscape and project specific feedback, which indicate that major Health Authorities (including the EMA) are moving towards a streamlined biosimilar clinical development, without comparative efficacy studies, Sandoz took a strategic decision and is winding down its CJPB898A12301 clinical study.
- Follow-up measures
- All patients currently in screening or randomized will complete the induction phase with the combination treatment of nivolumab plus ipilimumab within the study. Subsequently, Sandoz will ensure that patients will continue to receive treatment with nivolumab in the maintenance phase for up to one year. In countries/sites where no patients are currently enrolled, the study will be terminated.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-25 | Lithuania | Acceptable with conditions 2024-07-15
|
2024-07-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-15 | Lithuania | Acceptable 2025-01-17
|
2025-01-17 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-25 | Acceptable | 2025-03-24 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-02-25 | Acceptable | 2025-03-25 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-02-26 | Acceptable | 2025-04-28 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-03-03 | Acceptable | 2025-05-14 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-03-05 | Acceptable | 2025-04-09 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-04-29 | Acceptable | 2025-06-10 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-10-08 | Lithuania | Acceptable 2025-11-26
|
2025-11-26 |