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

NCT06794775 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2025-12-12

No results posted yet for this study

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.

Conditions

  • Malignant Melanoma Stage III

Interventions

DRUG

Nivolumab

Adjuvant monotherapy with Nivolumab

DRUG

Nivolumab + Ipilimumab

Adjuvant combination therapy with Nivolumab and Ipilimumab

Sponsors & Collaborators

  • Hildur Helgadottir

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06794775 on ClinicalTrials.gov