Clinical trial • Phase III • Oncology

Nivolumab for Malignant melanoma (resected stage IIB–III)

Phase III trial of Nivolumab for Malignant melanoma (resected stage IIB–III).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Malignant melanoma (resected stage IIB–III)
Trial Stage
Phase III
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
19-09-2025
First CTIS Authorization Date
27-01-2026

Trial design

Opdivo (nivolumab) US-licensed comparator; dose and schedule not specified-controlled Phase III trial across 29 sites in Italy, Romania, Spain and others.

Comparator
Opdivo (nivolumab) US-licensed comparator; dose and schedule not specified
Target Sample Size
73

Recruitment

Planned Sample Size
73
Recruitment Window Months
30

Geography

Total Number Of Sites
29
Total Number Of Participants
83

Italy

Earliest CTIS Part Ii Submission Date
12-12-2025
Latest Decision Or Authorization Date
27-01-2026
Processing Time Days
46
Number Of Sites
4
Number Of Participants
8

Sites

Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
Dipartimento Di Medicina Interna – Sod Clinica Oncologica
Contact Person Name
Rossana Berardi
Contact Person Email
R.Berardi@Univpm.It
Site Name
Azienda Ospedaliero-Universitaria Senese
Department Name
Uoc Immunoterapia Oncologica
Contact Person Name
Michele Maio
Contact Person Email
Maio@Unisi.It
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
U.O. Oncologia, Dipartimento Onco-Ematologico
Contact Person Name
Manolo D'Arcangelo
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
U.O. Oncologia
Contact Person Name
Alfredo Berruti
Contact Person Email
alfredo.berruti@gmail.com

Romania

Earliest CTIS Part Ii Submission Date
09-12-2025
Latest Decision Or Authorization Date
02-02-2026
Processing Time Days
55
Number Of Sites
1
Number Of Participants
15

Sites

Site Name
Centrul De Oncologie SF Nectarie S.R.L.
Department Name
Oncology
Contact Person Name
Michael Schenker
Contact Person Email
mike_schenker@yahoo.com

Spain

Earliest CTIS Part Ii Submission Date
04-11-2025
Latest Decision Or Authorization Date
02-02-2026
Processing Time Days
90
Number Of Sites
21
Number Of Participants
54

Sites

Site Name
Hospital San Pedro De Alcantara
Department Name
Oncologia Medica
Contact Person Name
Pablo Ayala de Miguel
Contact Person Email
pablo.ayala@salud-juntaex.es
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncologia Medica
Contact Person Name
Guillermo Antonio de Velasco Oria
Site Name
Hospital Universitario De Badajoz
Department Name
Oncologia Medica
Contact Person Name
Sara Leal Sanchez
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncologia Medica
Contact Person Name
Guillermo Antonio de Velasco Oria
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Oncologia Medica
Contact Person Name
Margarita Majem Tarruella
Contact Person Email
mmajem@santpau.cat
Site Name
Micancer Center S.L.P.
Department Name
Oncologia Medica
Contact Person Name
Alberto Rodrigo Cáceres
Contact Person Email
alberto.rodrigo@pratia.es
Site Name
Hospital Universitario De Torrejon
Department Name
Oncologia Medica
Contact Person Name
Vilma Pacheco-Barcia
Contact Person Email
vepacheco@torrejonsalud.com
Site Name
Hospital Clinic De Barcelona
Department Name
Oncologia Medica
Contact Person Name
Francisco Aya Moreno
Contact Person Email
faya@clinic.cat
Site Name
Complejo Hospitalario Universitario Insular Materno Infantil
Department Name
Oncologia Medica
Contact Person Name
Delvys Rodriguez Abreu
Contact Person Email
drodabr@gobiernodecanarias.org
Site Name
Hospital Universitario Regional De Malaga
Department Name
Oncologia Medica
Contact Person Name
Miguel Ángel Berciano Guerrero
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Oncologia Medica
Contact Person Name
Marta Sotelo Garcia
Contact Person Email
marta.sotelo@scsalud.es
Site Name
Micancer Center S.L.P.
Department Name
Oncologia Medica
Contact Person Name
Alberto Rodrigo Cáceres
Contact Person Email
alberto.rodrigo@pratia.es
Site Name
Hospital Universitario De Canarias
Department Name
Oncologia Medica
Contact Person Name
Juana Maria Oramas Rodriguez
Contact Person Email
jorarod@gobiernodecanarias.org
Site Name
Hospital Jerez Puerta Del Sur Grupo Hla S.A.
Department Name
Oncologia Medica
Contact Person Name
Ruben de Toro Salas
Contact Person Email
rdetoro@colaboradorhla.com
Site Name
Hospital Beata Maria Ana
Department Name
Oncologia Medica
Contact Person Name
Silvia Patricia Cortez Castedo
Contact Person Email
patricia.cortez@iob-onco.com
Site Name
MD Anderson Cancer Center
Department Name
Oncologia Medica
Contact Person Name
Fernando Fabio Franco Pérez
Contact Person Email
ffranco@fundacionmdanderson.es
Site Name
Hospital Beata Maria Ana
Department Name
Oncologia Medica
Contact Person Name
Silvia Patricia Cortez Castedo
Contact Person Email
patricia.cortez@iob-onco.com
Site Name
Hospital Universitari Dexeus Grupo Quironsalud
Department Name
Oncologia Medica
Contact Person Name
Maria González Cao
Contact Person Email
mgonzalezcao@oncorosell.com
Site Name
Hospital Universitario Central De Asturias
Department Name
Oncologia Medica
Contact Person Name
Daniel Martínez Pérez
Contact Person Email
daniel.martinezp@sespa.es
Site Name
Parc Tauli Hospital Universitari
Department Name
Oncologia Medica
Contact Person Name
Marina Sierra Boada
Contact Person Email
msierra@tauli.cat

Greece

Earliest CTIS Part Ii Submission Date
15-04-2026
Latest Decision Or Authorization Date
07-05-2026
Processing Time Days
22
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Athens Medical Center S.A.
Department Name
Oncology Department
Contact Person Name
Sofia Baka
Contact Person Email
bakasofia@hotmail.com
Site Name
Theageneio Cancer Hospital
Department Name
Oncology Department
Contact Person Name
Grigorios Rallis
Contact Person Email
grrallis@yahoo.com
Site Name
St. Luke's Hospital S.A.
Department Name
Oncology Department
Contact Person Name
Eleni Fountzila
Contact Person Email
elenafou@gmail.com

Sponsor

Primary sponsor

Full Name
H e x a l AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Investigational products

Investigational Product Name
JPB898
Active Substance
Nivolumab
Modality
Monoclonal antibody
Authorisation Status
Investigational (proposed biosimilar)
Investigational Product Name
Opdivo (US-licensed)
Active Substance
Nivolumab
Modality
Monoclonal antibody
Authorisation Status
Licensed (US-licensed comparator)

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