New trial tests which immunotherapy combo best battles melanoma before surgery
NCT ID NCT06794775
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests two different immunotherapy treatments given before surgery for stage III melanoma that can be removed. One group gets a single drug (PD-1 blocker), the other gets a two-drug combo (PD-1 and CTLA-4 blockers). The combo may work better but also has more side effects. About 128 adults with resectable stage III melanoma will take part.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 128 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Apr 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Karolinska University Hospital
RECRUITINGStockholm, Sweden
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Sahlgrenska University Hospital
RECRUITINGGothenburg, Sweden
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Skane University Hospital
RECRUITINGLund, Sweden