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

Recruiting Phase 3 Interventional Study
Malignant Melanoma Stage III
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
128 (estimated)
Sponsor
Hildur Helgadottir · Other
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About This Trial
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 as…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Participants must be at least 18 years of age. 2. Can provide a signed informed consent as described in the protocol, including compliance with the requirements and restrictions listed in the ICF and in this protocol. 3. World Health Organization (WHO) Performance Status 0 or…
Contacts

Hildur Helgadottir, MD, PhD

+46 8-123 734 15

hildur.helgadottir@regionstockholm.se

CONTACT

Roger Olofsson Bagge, Professor

+46313421000

roger.olofsson.bagge@gu.se

CONTACT