Malignant Melanoma Stage IIIPhase 3SWE-NEONCT06794775
SWE-NEO: Swedish NeoAdjuvant Trial Comparing Monotherapy to Combined Immunotherapy in Resectable Stage III Melanoma
A Phase 3 study testing Nivolumab and Nivolumab + Ipilimumab in people with Malignant Melanoma Stage III, run by Hildur Helgadottir at 3 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma Stage III
- What is being tested?
- Nivolumab and Nivolumab + Ipilimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 3 sitesSweden
- Study dates
- 10 Jul 2025to 15 Apr 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- No prior immunotherapy targeting CTLA-4, PD-1 or PD-L1.
- No prior targeted therapy targeting BRAF and/or MEK.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden3 sites, 3 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg
Lars Ny, MD, PhD, Principal Investigator, +4631-786 00 00, lars.ny@oncology.gu.se
- Recruiting
Skane University Hospital
Lund
Ana Carneiro, MD, PhD, Principal Investigator, +46 (0)46 222 00 00, Ana.SequeiraDeVasconcelosDiasCarneiro@skane.se
- Recruiting
Karolinska University Hospital
Stockholm
Hildur Helgadottir, MD, PhD, +46 8-123 734 15, hildur.helgadottir@regionstockholm.se
Hildur Helgadottir, MD, PhD
About this study
Official title: SWE-NEO: Swedish NeoAdjuvant Trial Comparing Anti-PD-1 Monotherapy to Combined Anti-CTLA-4/Anti-PD-1 Blockade in Resectable Stage III Melanoma
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.
Read the 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
- Being tested
- Nivolumab, Nivolumab + Ipilimumab
- Keywords
- Immune checkpoint inhibitors, Nivolumab, Ipilimumab, Neoadjuvant, anti-PD-1, anti-CTLA-4
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Adjuvant monotherapy with Nivolumab
Nivolumab + IpilimumabDrug
Adjuvant combination therapy with Nivolumab and Ipilimumab
| Study group | Role | What they receive |
|---|---|---|
| PD-1 inhibitor monotherapy | Active comparator | Monotherapy with Nivolumab Receives: Drug: Nivolumab |
| PD-1/CTLA-4 inhibitor combination therapy | Experimental | Combination therapy with Nivolumab and Ipilimumab Receives: Drug: Nivolumab + Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Relapse-free survival (RFS), defined as time between date of surgery and date of melanoma recurrence, treatment-related death or melanoma-related death, whichever occurs first.
Measured: 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)
Distant metastasis-free survival (DMFS), defined as time between date of randomization and date of first distant metastasis, treatment-related death or melanoma-related death, whichever occurs first.
Measured: 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)
Overall survival (OS), defined as time between date of randomization and date of death.
Measured: From date of randomization until the date of death from any cause, assessed up to 60 months
Major pathological response (MPR)
Major pathological response (MPR) (≤10% viable tumor cells), difference in MPR between combined ICI and monotherapy, central review of all surgical specimens by three expert melanoma pathologists.
Measured: Start of neoadjuvant therapy to end of neoadjuvant therapy, up to approximately two months
Correlation of pathologic response to RFS, DMFS, and OS
Correlation of pathologic response in each arm to RFS, DMFS, and OS.
Measured: 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
Correlation of response to RFS, DMFS, and OS
Correlation of radiological and clinical response evaluation to RFS, DMFS, and OS.
Measured: 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
Proportion of patients having surgery according to plan
Number of patients having surgery according to plan (within 10 weeks from first neoadjuvant course).
Measured: From start of neoadjuvant therapy to date of surgery, assessed up to 6 months
Surgical complication rates
Surgical complication rates according to Clavien-Dindo surgical classification.
Measured: From surgery to date of any postoperative complication, assessed up to 3 months post surgery
Frequency of treatment-related adverse events (AEs)
Frequency of all grade and grade 3-5 treatment-related adverse events (AEs) according to CTCAE 5.0.
Measured: From start of neoadjuvant therapy up to 1 year after last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start10 Jul 2025
- Primary completion15 Apr 2032 (estimated)
- Study completion15 Apr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Melanoma Stage IIIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hildur Helgadottir
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hildur Helgadottir, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06794775
- Sponsor's protocol ID
- SWE-NEO Trial
- Acronym
- SWE-NEO
- Status last verified
- Dec 2025
- First submitted
- 16 Jan 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SWE-NEO: Swedish NeoAdjuvant Trial Comparing Anti-PD-1 Monotherapy to Combined Anti-CTLA-4/Anti-PD-1 Blockade in Resectable Stage III Melanoma
- ClinicalTrials.gov ID
- NCT06794775
- Acronym / sponsor ID
- SWE-NEO / SWE-NEO Trial
- Conditions
- Malignant Melanoma Stage III
- Keywords
- Immune checkpoint inhibitors, Nivolumab, Ipilimumab, Neoadjuvant, anti-PD-1, anti-CTLA-4
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Hildur HelgadottirUniversity, hospital or other
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- 15 Apr 2032 (estimated)
- Study completion
- 15 Apr 2032 (estimated)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PD-1 inhibitor monotherapy | Active comparator | Drug: NivolumabMonotherapy with Nivolumab |
| PD-1/CTLA-4 inhibitor combination therapy | Experimental | Drug: Nivolumab + IpilimumabCombination therapy with Nivolumab and Ipilimumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabAdjuvant monotherapy with Nivolumab | Drug | PD-1 inhibitor monotherapy |
| Nivolumab + IpilimumabAdjuvant combination therapy with Nivolumab and Ipilimumab | Drug | PD-1/CTLA-4 inhibitor combination therapy |
Primary outcome
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
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).
9 secondary outcomes
Relapse-free survival (RFS)
Time frame: 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)
Time frame: 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)
Time frame: From date of randomization until the date of death from any cause, assessed up to 60 months
Major pathological response (MPR)
Time frame: Start of neoadjuvant therapy to end of neoadjuvant therapy, up to approximately two months
Correlation of pathologic response to RFS, DMFS, and OS
Time frame: 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
Correlation of response to RFS, DMFS, and OS
Time frame: 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
Proportion of patients having surgery according to plan
Time frame: From start of neoadjuvant therapy to date of surgery, assessed up to 6 months
Surgical complication rates
Time frame: From surgery to date of any postoperative complication, assessed up to 3 months post surgery
Frequency of treatment-related adverse events (AEs)
Time frame: From start of neoadjuvant therapy up to 1 year after last treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nivolumab and Nivolumab + Ipilimumab in people with Malignant Melanoma Stage III, run by Hildur Helgadottir at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hildur Helgadottir, MD, PhD (+46 8-123 734 15, hildur.helgadottir@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.