RecruitingPhase 3NCT06794775

SWE-NEO: Swedish NeoAdjuvant Trial Comparing Monotherapy to Combined Immunotherapy in Resectable Stage III Melanoma

SWE-NEO: Swedish NeoAdjuvant Trial Comparing Anti-PD-1 Monotherapy to Combined Anti-CTLA-4/Anti-PD-1 Blockade in Resectable Stage III Melanoma


Sponsor

Hildur Helgadottir

Enrollment

128 participants

Start Date

Jul 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Swedish study is testing whether giving a single immunotherapy drug (nivolumab) or two immunotherapy drugs (nivolumab + ipilimumab) before surgery works better for people with stage III melanoma that can be surgically removed. The goal is to shrink the cancer before surgery and reduce the chance it comes back. **You may be eligible if...** - You are 18 or older - You have been diagnosed with stage III melanoma that doctors believe can be fully removed by surgery - Your melanoma is skin-based, on the foot/hand (acral), or from an unknown primary site - You are generally in good health (able to carry out daily activities) - You have not previously received immunotherapy or targeted therapy (BRAF/MEK inhibitors) for melanoma - You are able to use effective contraception if applicable **You may NOT be eligible if...** - Your melanoma is in the eye (uveal/ocular) or from a mucous membrane - Your tumor cannot be completely removed with surgery - You require high-dose steroids or other immune-suppressing medications - You are pregnant or breastfeeding - You have another serious medical condition that could interfere with treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNivolumab

Adjuvant monotherapy with Nivolumab

DRUGNivolumab + Ipilimumab

Adjuvant combination therapy with Nivolumab and Ipilimumab


Locations(3)

Sahlgrenska University Hospital

Gothenburg, Sweden

Skane University Hospital

Lund, Sweden

Karolinska University Hospital

Stockholm, Sweden

View Full Details on ClinicalTrials.gov

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NCT06794775