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

Conditions

• Malignant Melanoma Stage III

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Nivolumab — DRUG
  Adjuvant monotherapy with Nivolumab
• Nivolumab + Ipilimumab — DRUG
  Adjuvant combination therapy with Nivolumab and Ipilimumab

Study Details

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.

Key Dates

Start date

Jul 10, 2025

Status verified

Dec 2025

Primary completion

Apr 15, 2032

Completion

Apr 15, 2032

Study Design

Enrollment

128 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: PD-1 inhibitor monotherapy
  Monotherapy with Nivolumab
• Experimental: PD-1/CTLA-4 inhibitor combination therapy
  Combination therapy with Nivolumab and Ipilimumab

Primary Outcome Measure

Event-free survival (EFS) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months ]

Central Contacts

• Hildur Helgadottir, MD, PhD
  +46 8-123 734 15
  [email protected]
• Roger Olofsson Bagge, Professor
  +46313421000
  [email protected]