Clinical trial • Phase III • Oncology

pembrolizumab for Cutaneous malignant melanoma

Phase III trial of pembrolizumab for Cutaneous malignant melanoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Cutaneous malignant melanoma
Trial Stage
Phase III
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
20-06-2024
First CTIS Authorization Date
10-10-2024

Trial design

Randomised, short (6 months) versus long (12 months) adjuvant immunotherapy; specific drug dosing and schedule not specified in the record.-controlled Phase III trial across 28 sites in Norway, Sweden, Finland.

Randomised
Yes
Comparator
Short (6 months) versus Long (12 months) adjuvant immunotherapy; specific drug dosing and schedule not specified in the record.
Target Sample Size
1800

Eligibility

Recruits 1800 adults.

Inclusion criteria

  • {"criterion_text":"- 1) Performance status WHO 0-1. 2) Radical surgery for cutaneous malignant melanoma stage IIb-c, III and IV."}

Exclusion criteria

  • {"criterion_text":"- 1) The patient is assessed as unfit to receive systemic adjuvant treatment. 2) An active, known, or suspected autoimmune disease."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Distant metastatic free survival (DMFS) and relapse free survival (RFS).","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
1800
Recruitment Window Months
120
Consent Approach
Subject information sheets and informed consent forms are listed in the record (L1_SIS and ICF Main and Sampling) with language versions: Norwegian (NO), Swedish (SV) and Finnish (FI). No explicit description of assent or age-specific consent processes is provided in the available record.

Geography

Total Number Of Sites
28
Total Number Of Participants
1800

Norway

Earliest CTIS Part Ii Submission Date
12-09-2024
Latest Decision Or Authorization Date
04-04-2025
Processing Time Days
204
Number Of Sites
8
Number Of Participants
600

Sites

Site Name
Sorlandet Sykehus HF
Department Name
Department of Oncology
Contact Person Name
Unn-Miriam Kasti
Contact Person Email
unn-miriam.kasti@sshf.no
Site Name
Helse Stavanger HF
Department Name
Department of Hematology and Oncology
Contact Person Name
Israr Hussain
Contact Person Email
Israr.hussain@sus.no
Site Name
St. Olavs Hospital HF
Department Name
Department of oncology
Contact Person Name
Jarle Karlsen
Contact Person Email
jarle.karlsen@stolav.no
Site Name
Akershus University Hospital
Department Name
Department of oncology
Contact Person Name
Martin Ruppert
Contact Person Email
Martin.C.F.Ruppert@ahus.no
Site Name
Helse Moere Og Romsdal HF
Department Name
Department of Oncology
Contact Person Name
Torbjørg Skåravik
Contact Person Email
postmottak@helse-mr.no
Site Name
Oslo University Hospital HF
Department Name
Department of Oncology
Contact Person Name
Henrik Jespersen
Contact Person Email
hejes@ous-hf.no
Site Name
Helse Bergen HF
Department Name
Department of Oncology
Contact Person Name
Cornelia Schuster
Site Name
Universitetssykehuset Nord-Norge HF
Department Name
Department of oncology
Contact Person Name
Anita Amundsen
Contact Person Email
Anita.amundsen@unn.no

Sweden

Earliest CTIS Part Ii Submission Date
16-09-2024
Latest Decision Or Authorization Date
16-05-2025
Processing Time Days
242
Number Of Sites
16
Number Of Participants
800

Sites

Site Name
Region Vaestmanland
Department Name
Department of oncology
Contact Person Name
Tania-Mihaela Nicolaescu
Site Name
Region Kronoberg
Department Name
Centrallasarettet Växjö, Strandvägen 8, 351 85 Växjö, Onkologi
Contact Person Name
Signe Carlsson
Contact Person Email
fou@kronoberg.se
Site Name
Malarsjukhuset Eskilstuna
Department Name
Department of oncology
Contact Person Name
Andreas Nearchaou
Site Name
Region Vaesterbotten
Department Name
Norrlands universitetssjukhus, Daniel Naezéns väg, 907 37 Umeå, Onkologi
Contact Person Name
Ylva Holmgren
Site Name
Region Vaesternorrland
Department Name
Department of oncology
Contact Person Name
Petra Flygare
Contact Person Email
Petra.Flygare@rvn.se
Site Name
Region Joenkoepings Laen
Department Name
Department of oncology
Contact Person Name
Mikael Wallander
Contact Person Email
mikael.wallander@rjl.se
Site Name
Region Dalarna
Department Name
Department of oncology
Contact Person Name
Gustav Ullenhag
Contact Person Email
gustav.ullenhag@igp.uu.se
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Department of oncology
Contact Person Name
Ana Carneiro
Contact Person Email
Ana.Carneiro@Skane.se
Site Name
Region Gaevleborg
Department Name
Department of oncology
Contact Person Name
Olga val Munos
Site Name
Sahlgrenska University Hospital-Vastra Gotalandsregionen
Department Name
Department of oncology
Contact Person Name
Lars Ny
Contact Person Email
lars.ny@gu.se
Site Name
Karolinska University Hospital
Department Name
Department of oncology
Contact Person Name
Hildur Helgadottir
Contact Person Email
anna.nilsson.1@ki.se
Site Name
Laenssjukhuset I Kalmar Region Kalmar Laen
Department Name
Department of oncology
Contact Person Name
Magnus Lagerlund
Contact Person Email
Magnus.Lagerlund@ltkalmar.se
Site Name
Uppsala University Hospital
Department Name
Department of oncology
Contact Person Name
Gustav Ullenhag
Contact Person Email
gustav.ullenhag@igp.uu.se
Site Name
Linkoping University Hospital Region Ostergotland
Department Name
Department of oncology
Contact Person Name
Sander Ellegård
Contact Person Email
region@regionostergotland.se
Site Name
Region Oerebro Laen
Department Name
Department of oncology
Contact Person Name
Georgios Fountoukidis
Site Name
Region Vaermland
Department Name
Department of oncology
Contact Person Name
Emelie Bengtsson
Contact Person Email
region@regionvarmland.se

Finland

Earliest CTIS Part Ii Submission Date
13-09-2024
Latest Decision Or Authorization Date
21-06-2025
Processing Time Days
281
Number Of Sites
4
Number Of Participants
400

Sites

Site Name
Tampere University Hospital
Department Name
Department of Oncology
Contact Person Name
Tanja Skyttä
Contact Person Email
tanja.skytta@pirha.fi
Site Name
Turku University Hospital
Department Name
Department of Oncology
Contact Person Name
Veera Sivonen
Contact Person Email
veera.sivonen@varha.fi
Site Name
HUS-Yhtymae
Department Name
Department of Oncology
Contact Person Name
Micaela Hernberg
Contact Person Email
micaela.hernberg@hus.fi
Site Name
Kuopio University Hospital
Department Name
Department of Oncology
Contact Person Name
Okko-Sakari Kääriäinen

Sponsor

Primary sponsor

Full Name
Uppsala University Hospital
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Sweden

Co-sponsors

  • North Estonia Medical Centre Foundation
  • Vilniaus universiteto ligonine Santaros klinikos VšĮ
  • Rigas Austrumu kliniska universitates slimnica SIA
  • Universita Degli Studi Di Perugia

Investigational products

Investigational Product Name
KEYTRUDA 25 mg/mL concentrate for solution for infusion
Active Substance
pembrolizumab
Modality
Monoclonal antibody
Routes Of Administration
Infusion
Route
Infusion
Authorisation Status
Marketing authorisation (EU)
Maximum Dose
400 mg (max daily); 3600 mg (max total)
Investigational Product Name
OPDIVO 10 mg/mL concentrate for solution for infusion.
Active Substance
nivolumab
Modality
Monoclonal antibody
Routes Of Administration
Infusion
Route
Infusion
Authorisation Status
Marketing authorisation (EU)
Maximum Dose
480 mg (max daily); 5760 mg (max total)

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