drugset / Trial / NCT06794775

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

NCT06794775

Phase 3 Recruiting 128 enrolled Hildur Helgadottir
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-07-10
Primary completion
2032-04-15
Completion
2032-04-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Ipilimumab Monoclonal antibody
Comparator Nivolumab Monoclonal antibody

Indications