Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
1,800
Countries
3
Sites
30
cutaneous malignant melanoma
To assess whether adjuvant treatment with immunotherapy for 6 months is as effective as 12 months in patients with stage IIb-c, III and IV cutaneous malignant melanoma.
Key facts
- Sponsor
- Uppsala University Hospital, North Estonia Medical Centre Foundation, Vilniaus universiteto ligonine Santaros klinikos VšĮ, Rigas Austrumu kliniska universitates slimnica SIA, Universita Degli Studi Di Perugia
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 15 Nov 2024 → ongoing
- Decision date (initial)
- 2024-10-15
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Stiftelsen onkologiska klinikens i Uppsala forskningsfond · Uppsala university hospital
External identifiers
- EU CT number
- 2023-509994-22-00
- ClinicalTrials.gov
- NCT06488482
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
To assess whether adjuvant treatment with immunotherapy for 6 months is as effective as 12 months in patients with stage IIb-c, III and IV cutaneous malignant melanoma.
Secondary objectives 1
- To assess long-term distant metastatic free survival (DMFS), relapse free survival (RFS) and overall survival (OS) after 6 months compared to 12 months immunotherapy.
Conditions and MedDRA coding
cutaneous malignant melanoma
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 1) Performance status WHO 0-1. 2) Radical surgery for cutaneous malignant melanoma stage IIb-c, III and IV.
Exclusion criteria 1
- 1) The patient is assessed as unfit to receive systemic adjuvant treatment. 2) An active, known, or suspected autoimmune disease.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Distant metastatic free survival (DMFS) and relapse free survival (RFS).
Secondary endpoints 1
- Overall survival (OS)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
KEYTRUDA 25 mg/mL concentrate for solution for infusion
PRD4323105 · Product
- Active substance
- Pembrolizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 3600 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF02 — -
- Marketing authorisation
- EU/1/15/1024/002
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
OPDIVO 10 mg/mL concentrate for solution for infusion.
PRD2941372 · Product
- Active substance
- Nivolumab
- Substance synonyms
- BMS936558, ABP 206
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 480 mg milligram(s)
- Max total dose
- 5760 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF01 — -
- Marketing authorisation
- EU/1/15/1014/001
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Uppsala University Hospital
- Sponsor organisation
- Uppsala University Hospital
- Address
- Sjukhusvagen 85
- City
- Uppsala
- Postcode
- 751 85
- Country
- Sweden
Scientific contact point
- Organisation
- Uppsala University Hospital
- Contact name
- Gustav Ullenhag
Public contact point
- Organisation
- Uppsala University Hospital
- Contact name
- Gustav Ullenhag
North Estonia Medical Centre Foundation
- Sponsor organisation
- North Estonia Medical Centre Foundation
- Address
- J. Sutiste Tee 19, Mustamae Linnaosa Mustamae Linnaosa
- City
- Tallinn
- Postcode
- 13419
- Country
- Estonia
Scientific contact point
- Organisation
- North Estonia Medical Centre Foundation
- Contact name
- Kadri Putnik
Public contact point
- Organisation
- North Estonia Medical Centre Foundation
- Contact name
- Kadri Putnik
Vilniaus universiteto ligonine Santaros klinikos VšĮ
- Sponsor organisation
- Vilniaus universiteto ligonine Santaros klinikos VšĮ
- Address
- Santariskiu G. 1, Vilniaus M. Sav. Vilniaus M. Sav.
- City
- Vilnius
- Postcode
- 08660
- Country
- Lithuania
Scientific contact point
- Organisation
- Vilniaus universiteto ligonine Santaros klinikos VšĮ
- Contact name
- National Cancer Center
Public contact point
- Organisation
- Vilniaus universiteto ligonine Santaros klinikos VšĮ
- Contact name
- National Cancer Center
Rigas Austrumu kliniska universitates slimnica SIA
- Sponsor organisation
- Rigas Austrumu kliniska universitates slimnica SIA
- Address
- Hipokrata Iela 4
- City
- Riga
- Postcode
- 1079
- Country
- Latvia
Scientific contact point
- Organisation
- Rigas Austrumu kliniska universitates slimnica SIA
- Contact name
- Latvian Oncology Center
Public contact point
- Organisation
- Rigas Austrumu kliniska universitates slimnica SIA
- Contact name
- Latvian Oncology Center
Universita Degli Studi Di Perugia
- Sponsor organisation
- Universita Degli Studi Di Perugia
- Address
- Piazza Dell' Universita' 1
- City
- Perugia
- Postcode
- 06123
- Country
- Italy
Scientific contact point
- Organisation
- Universita Degli Studi Di Perugia
- Contact name
- Department of Medicine and Surgery
Public contact point
- Organisation
- Universita Degli Studi Di Perugia
- Contact name
- Department of Medicine and Surgery
Sponsor responsibilities
- Article 77 compliance
- Uppsala University Hospital
- Contact point sponsor
- Uppsala University Hospital
- Article 77 implementation
- Uppsala University Hospital
Locations
3 EU/EEA countries · 30 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ongoing, recruiting | 400 | 4 |
| Norway | Ongoing, recruiting | 600 | 10 |
| Sweden | Ongoing, recruiting | 800 | 16 |
| Rest of world | — | 0 | — |
Investigational sites
HUS-Yhtymae
Department of Oncology, Haartmaninkatu 4, 00290, Helsinki
Turku University Hospital
Department of Oncology, Hameentie 11, 20520, Turku
Tampere University Hospital
Department of Oncology, Elamanaukio 2, 33520, Tampere
Kuopio University Hospital
Department of Oncology, Puijonlaaksontie 2, P. O. Box 1777, Kuopio
Vestre Viken HF
Kreftpoliklinikken, Jacob Borchs Gate 10, 3004, Drammen
Sykehuset I Vestfold HF
Senter for kreft og blodsykdommer, Halfdan Wilhelmsens Alle 17, 3116, Toensberg
St. Olavs Hospital HF
Department of oncology, Prinsesse Kristinas G. 3, 7030, Trondheim
Helse Moere Og Romsdal HF
Department of Oncology, Aasehaugen 5, 6017, Aalesund
Universitetssykehuset Nord-Norge HF
Department of oncology, P. O. Box 100, 9038, Tromsoe
Sorlandet Sykehus HF
Department of Oncology, Egsveien 100, 4615, Kristiansand S
Helse Stavanger HF
Department of Hematology and Oncology, Gerd-Ragna Bloch Thorsens Gate 8, 4011, Stavanger
Akershus University Hospital
Department of oncology, Sykehusveien 27, 1478, Lorenskog
Helse Bergen HF
Department of Oncology, Jonas Lies Vei 65, 5021, Bergen
Oslo University Hospital HF
Department of Oncology, Taarnbygget, Kirkeveien 166, Oslo
Laenssjukhuset I Kalmar Region Kalmar Laen
Department of oncology, Lasarettsvagen 8, Kalmar S:t Johannes, Kalmar
Region Skane Skanes Universitetssjukhus
Department of oncology, Entregatan 7, 222 42, Lund
Uppsala University Hospital
Department of oncology, Sjukhusvagen 85, 751 85, Uppsala
Region Vaestmanland
Department of oncology, Sigtunagatan, 721 89, Vasteras
Region Kronoberg
Centrallasarettet Växjö, Strandvägen 8, 351 85 Växjö, Onkologi, Nygatan 20, Vaxjo Stads- Och Domkyrkofors., Vaxjo
Region Oerebro Laen
Department of oncology, Sodra Grev Rosengatan, 701 85, Orebro
Region Vaesterbotten
Norrlands universitetssjukhus, Daniel Naezéns väg, 907 37 Umeå, Onkologi, Koksvagen 11, Alidhem, Umea
Region Gaevleborg
Department of oncology, Rektorsgatan 1, 802 50, Gavle
Region Dalarna
Department of oncology, Vasagatan 27, Falu Kristine, Falun
Karolinska University Hospital
Department of oncology, Norrbacka S3 02, 171 76, Stockholm
Region Vaermland
Department of oncology, Rosenborgsgatan 50, 652 33, Karlstad
Region Joenkoepings Laen
Department of oncology, Lanssjukhuset Ryhov, Sjukhusgatan, Jonkoping
Malarsjukhuset Eskilstuna
Department of oncology, Kungsvagen 42, Tunafors, Eskilstuna
Sahlgrenska University Hospital-Vastra Gotalandsregionen
Department of oncology, Bla Straket 5, 413 46, Goteborg
Linkoping University Hospital Region Ostergotland
Department of oncology, Universitetssjukhuset I Linkoping, 581 85, Linkoping
Region Vaesternorrland
Department of oncology, Lasarettsvagen 21, 856 43, Sundsvall
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 |
|---|---|---|---|---|---|
| Finland | 2025-03-31 | 2025-04-24 | |||
| Norway | 2025-02-03 | 2025-04-08 | |||
| Sweden | 2024-11-15 | 2024-12-19 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 16 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-509994-22-00 | 6.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements EN | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements EN | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main FI | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main NO | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main SV | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_EN-GB | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Sampling FI | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Sampling NO | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Sampling SV | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Nivolumab | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Pembrolizumab | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis EN 2023-509994-22-00 | 5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis NO 2023-509994-22-00 | 5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis SV 2023-509994-22-00 | 5.0 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-20 | Sweden | Acceptable 2024-10-10
|
2024-10-10 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-02 | Acceptable | 2025-04-04 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-04-02 | Acceptable | 2025-06-21 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-03 | Sweden | Acceptable | 2025-05-16 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-06-25 | Sweden | Acceptable 2025-08-13
|
2025-08-14 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-03-25 | Sweden | Acceptable 2026-05-13
|
2026-05-15 |