NCT06794775

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Hildur Helgadottir · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A phase III randomized controlled multicenter open-label trial. Patients will be randomized after a diagnosis of resectable stage III melanoma to have either two courses of CTLA-4 and PD-1 inhibitor combination therapy or PD-1 inhibitor monotherapy, before the pre-planned operation. In both arms, adjuvant treatment with a PD-1 inhibitor or with BRAF+MEK inhibitors in patients with a BRAF V600E mutation, will be given only to patients with no major pathological response in the operated tumor, with PD-1 inhibitor, or with BRAF+MEK inhibitors in patients with BRAF V600E mutation. Active follow-up will be performed for 3 years from surgery and followed for survival up until 10 years. Sequential blood and tumor samples will be collected for biomarker analyses.

Conditions

• Malignant Melanoma Stage III

Interventions

Type	Name	Description
DRUG	Nivolumab	Adjuvant monotherapy with Nivolumab
DRUG	Nivolumab + Ipilimumab	Adjuvant combination therapy with Nivolumab and Ipilimumab

Timeline

• Start date: 2025-07-10
• Primary completion: 2032-04-15
• Completion: 2032-04-15
• First posted: 2025-01-27
• Last updated: 2025-12-12

Locations

3 sites across 1 country: Sweden