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Clinical trial Recruiting at 3 sites Phase 3 Interventional Ages 18 and up

Neoadjuvant nivolumab alone versus nivolumab plus ipilimumab for resectable stage III melanoma

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

Run by Karolinska University Hospital · NCT06794775 · Data updated 2026-11-12

This trial will try two pre-surgery immunotherapy approaches—nivolumab alone or nivolumab plus ipilimumab—in adults with resectable stage III melanoma to see which gives better tumor response and longer benefit.

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment128 (estimated)
SponsorKarolinska University Hospital
Academic / other
Drugs / interventionsimmunotherapy, prednisone
Locations3 sites (Gothenburg and 2 other locations)
StatusRecruiting
StartedJuly 10, 2025
Main results expectedApril 15, 2032
Study endsApril 15, 2032
Registry record updatedDecember 12, 2025
Trial IDNCT06794775 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18 years) with histologically confirmed resectable stage III cutaneous, acral, or unknown primary melanoma, WHO performance status 0–1, and who can undergo complete surgical resection are ideal candidates.

Probably not a fit

Patients with unresectable disease, significant comorbidities that prevent safe use of immunotherapy or surgery, or those unlikely to tolerate higher rates of immune-related toxicity may not receive benefit from the combined regimen.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase III, randomized, open-label multicenter trial in patients with resectable stage III melanoma who are randomized to receive either two courses of nivolumab monotherapy or two courses of combined nivolumab plus ipilimumab prior to planned surgical resection. After surgery, patients without a major pathological response receive adjuvant PD‑1 inhibitor therapy or BRAF+MEK inhibitors for BRAF V600E-mutant tumors, while those with a major pathological response do not receive routine adjuvant therapy. Active clinical follow-up is conducted for three years after surgery with survival follow-up up to ten years. Sequential blood and tumor samples are collected for biomarker analyses to correlate molecular features with treatment response.

Why it matters

Potential benefit: If successful, the trial could show whether adding ipilimumab before surgery increases tumor clearance and improves long-term outcomes for resectable stage III melanoma patients.

How similar studies have gone: Prior randomized neoadjuvant trials (SWOG S1801 and NADINA) showed advantages for neoadjuvant approaches versus adjuvant-only therapy, but a direct head-to-head comparison of PD‑1 alone versus PD‑1/CTLA‑4 combination in this setting is novel.

Who can join: the full rules

Show full inclusion / exclusion 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 1.
4. Patients must have

   1. 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.
   2. Patients with cutaneous, acral, or unknown primary melanomas are eligible for enrollment.
   3. 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.
5. 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.
6. 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:

   1. 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;
   2. hormonal (oral, intravaginal, transdermal, implantable or injectable)
   3. an intrauterine hormone-releasing system (IUS)
   4. an intrauterine device (IUD) with a documented failure rate of \< 1%.
7. 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.
8. No other malignancies, except if treated with curative intent and with a cancer-related life expectancy of more than 5 years.
9. No prior immunotherapy targeting CTLA-4, PD-1 or PD-L1.
10. No prior targeted therapy targeting BRAF and/or MEK.

Exclusion Criteria:

1. Unresectable melanoma
2. Uveal/ocular or mucosal melanoma
3. 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 .
4. 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.
5. Women who are pregnant or breastfeeding.
6. 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.

Where it's running

  • Sahlgrenska University Hospital
    Gothenburg, Sweden     Recruiting
  • Skane University Hospital
    Lund, Sweden     Recruiting
  • Karolinska University Hospital
    Stockholm, Sweden     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.