Actively Recruiting
SWE-NEO: Swedish NeoAdjuvant Trial Comparing Monotherapy to Combined Immunotherapy in Resectable Stage III Melanoma
Led by Hildur Helgadottir · Updated on 2025-12-12
128
Participants Needed
3
Research Sites
353 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
At present two studies (SWOG S1801 and NADINA) have demonstrated superiority when using neoadjuvant treatment compared to adjuvant treatment only, but no studies have compared PD-1 monotherapy (SWOG 1801 regimen) to the PD-1/CTLA-4 combination (NADINA regimen) therapy. The SWE-NEO study aims to compare these two regimens, where the PD-1/CTLA-4 combination is potentially more effective, but also associated with more side effects.
CONDITIONS
Official Title
SWE-NEO: Swedish NeoAdjuvant Trial Comparing Monotherapy to Combined Immunotherapy in Resectable Stage III Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be at least 18 years of age.
- Ability to provide signed informed consent and comply with study requirements.
- World Health Organization (WHO) Performance Status of 0 or 1.
- Histologically or cytologically confirmed stage III melanoma.
- Up to 3 resectable in-transit metastases allowed with or without lymph node metastases.
- Patients with cutaneous, acral, or unknown primary melanomas are eligible.
- Tumors must be resectable with no significant vascular, neural, or bony involvement and complete surgical removal with tumor-free margins must be achievable.
- Female patients of childbearing potential must have a negative pregnancy test within 72 hours before treatment and agree to use highly effective contraception during the study and for 150 days after last dose.
- Male patients of childbearing potential must agree to use adequate contraception during the study and for 150 days after last dose.
- No other malignancies unless treated with curative intent and life expectancy over 5 years.
- No prior immunotherapy targeting CTLA-4, PD-1, or PD-L1.
- No prior targeted therapy against BRAF and/or MEK.
You will not qualify if you...
- Melanoma that cannot be surgically removed.
- Uveal/ocular or mucosal melanoma.
- Serious or uncontrolled medical conditions that increase risk or interfere with treatment or study results.
- Need for systemic corticosteroids over 10 mg prednisone daily or other immunosuppressive drugs within 14 days before treatment (inhaled or topical steroids allowed without active autoimmune disease).
- Women who are pregnant or breastfeeding.
- Any condition that may prevent compliance with the study protocol or follow-up schedule.
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Sahlgrenska University Hospital
Gothenburg, Sweden
Actively Recruiting
2
Skane University Hospital
Lund, Sweden
Actively Recruiting
3
Karolinska University Hospital
Stockholm, Sweden
Actively Recruiting
Research Team
H
Hildur Helgadottir, MD, PhD
CONTACT
R
Roger Olofsson Bagge, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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