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

NCT06794775 | Recruiting Phase 3 DMC

• 1 other identifier: SWE-NEO Trial
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Immune checkpoint inhibitors; Nivolumab; Ipilimumab; Neoadjuvant; anti-PD-1; anti-CTLA-4

Outcome Measures

Primary Outcomes (1)

• Event-free survival (EFS)

  Event-free survival (EFS), defined as time from randomization to melanoma progression (irresectable stage III or stage IV disease), melanoma recurrence, or death from any cause (treatment-related, melanoma related or any other).

  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

Secondary Outcomes (9)

• Relapse-free survival (RFS)

  From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

• Distant metastasis-free survival (DMFS)

  From date of randomization until the date of first documented distant metastasis or date of death from any cause, whichever came first, assessed up to 60 months

• Overall survival (OS)

  From date of randomization until the date of death from any cause, assessed up to 60 months

• Major pathological response (MPR)

  Start of neoadjuvant therapy to end of neoadjuvant therapy, up to approximately two months

• Correlation of pathologic response to RFS, DMFS, and OS

  From end of neoadjuvant therapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

Other Outcomes (1)

• Correlation of different biological markers with treatment efficacy and safety

  From start of neoadjuvant therapy to last blood/tumour sample taken, until the date of first documented progression, assessed up to 60 months

Study Arms (2)

PD-1 inhibitor monotherapy

ACTIVE COMPARATOR

Monotherapy with Nivolumab

Drug: Nivolumab

PD-1/CTLA-4 inhibitor combination therapy

EXPERIMENTAL

Combination therapy with Nivolumab and Ipilimumab

Drug: Nivolumab + Ipilimumab

Interventions

Nivolumab DRUG

Adjuvant monotherapy with Nivolumab

PD-1 inhibitor monotherapy

Nivolumab + Ipilimumab DRUG

Adjuvant combination therapy with Nivolumab and Ipilimumab

PD-1/CTLA-4 inhibitor combination therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be at least 18 years of age.
• 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.
• World Health Organization (WHO) Performance Status 0 or 1.
• Patients must have
• Histologically or cytologically confirmed Stage III melanoma. In the case of in-transit metastases (with or without lymph node metastases)' ≤3 resectable in-transit metastases are allowed.
• Patients with cutaneous, acral, or unknown primary melanomas are eligible for enrollment.
• Resectable tumors are defined as having no significant vascular, neural or bony involvement. Only patients where a complete surgical resection with tumor-free margins can safely be achieved are defined as resectable.
• Female patient of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
• Female patients of childbearing potential must be willing to use a highly effective method of contraception, for the course of the study through 150 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject. Highly effective methods of contraception include one or more of the following:
• male partner who is sterile (vasectomised) prior to the female study subject's entry into the study and is the sole sexual partner for the female subject;
• hormonal (oral, intravaginal, transdermal, implantable or injectable)
• an intrauterine hormone-releasing system (IUS)
• an intrauterine device (IUD) with a documented failure rate of \< 1%.
• Male patients of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 150 days after the last dose of study therapy. Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject. A unique female sexual partner must postmenopausal, permanently sterilized (e.g. hysterectomy or tubal ligation), or use a highly effective method of contraception.
• No other malignancies, except if treated with curative intent and with a cancer-related life expectancy of more than 5 years.

You may not qualify if:

• Unresectable melanoma
• Uveal/ocular or mucosal melanoma
• Any serious or uncontrolled medical conditions that, in the investigator's opinion, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results .
• Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
• Women who are pregnant or breastfeeding.
• Any condition that potentially hamper compliance with the study protocol and follow-up schedule; those conditions should be discussed with the subject before registration in the trial.

Sponsors & Collaborators

• Hildur Helgadottir: lead

Study Sites (3)

Sahlgrenska University Hospital

Gothenburg, Sweden

RECRUITING

Skane University Hospital

Lund, Sweden

RECRUITING

Karolinska University Hospital

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

Nivolumab; Ipilimumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Hildur Helgadottir, MD, PhD

CONTACT

+46 8-123 734 15; hildur.helgadottir@regionstockholm.se

Roger Olofsson Bagge, Professor

CONTACT

+46313421000; roger.olofsson.bagge@gu.se

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Oncology consultant

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 27, 2025
• Study Start: July 10, 2025
• Primary Completion (Estimated): April 15, 2032
• Study Completion (Estimated): April 15, 2032
• Last Updated: December 12, 2025

Record last verified: 2025-12

Locations

SE (3)