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Compares treatment options for Malignant Melanoma Stage III
Official title SWE-NEO: Swedish NeoAdjuvant Trial Comparing Monotherapy to Combined Immunotherapy in Resectable Stage III Melanoma
ClinicalTrials.gov ID: NCT06794775
What this study is testing
What is Nivolumab?
Nivolumab is an investigational medicine, being studied as a potential treatment for malignant melanoma stage iii.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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...
You likely can't join 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...
- people with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive...
- 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...
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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.
- 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...
- people 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Gothenburg, Sweden
- Lund, Sweden
- Stockholm, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gothenburg, Sweden; Lund, Sweden; Stockholm, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.