At a glance
ClinicalIndex Comparison Record- ✓Age at least 18 years
- ✓Histologically or cytologically confirmed Stage III melanoma
- ✓Resectable tumors with no significant vascular, neural or bony involvement and complete surgical resection with tumor-free margins achievable
- ✓≤3 resectable in-transit metastases allowed
- ✕Unresectable melanoma
- ✕Uveal/ocular or mucosal melanoma
- ✕Serious or uncontrolled medical conditions increasing risk or impairing protocol therapy
- ✕Pregnant or breastfeeding women
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
SWE-NEO: Swedish NeoAdjuvant Trial Comparing Anti-PD-1 Monotherapy to Combined Anti-CTLA-4/Anti-PD-1 Blockade in Resectable Stage III Melanoma
In Brief
A Phase 3 clinical trial evaluating Nivolumab and Nivolumab + Ipilimumab for Malignant Melanoma Stage III. Currently recruiting, targeting 128 participants across 3 sites.
Detailed 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.
Study Details
Timeline
Interventions
Adjuvant monotherapy with Nivolumab
Adjuvant combination therapy with Nivolumab and Ipilimumab