Can a short Pre-Surgery immunotherapy course replace Long-Term adjuvant treatment for melanoma?
NCT ID NCT07740941
First seen Aug 03, 2026 · Last updated Aug 06, 2026 · Updated 3 times
Summary
This phase 2 trial is investigating whether giving immunotherapy before surgery for advanced melanoma (stage IIIB to IV M1a) can maintain survival while allowing patients to skip the usual adjuvant therapy after surgery. Participants are randomly assigned to receive either two infusions of pembrolizumab or a combination of ipilimumab plus nivolumab followed by a single nivolumab infusion. The study will track overall survival at two years and event-free survival at one year to see if this neoadjuvant approach is as effective as the standard path.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pembrolizumab or ipilimumab plus nivolumab
- What this could lead to
- If successful, this approach could show that a short course of immunotherapy before surgery is enough to control advanced melanoma, potentially reducing the need for lengthy adjuvant treatment.
- What could go wrong
- This is a phase 2 trial with a relatively small number of participants, so results may not be definitive. Immunotherapy can cause immune-related side effects, and the non-inferiority design means it aims to show the new approach is not worse than standard care, not necessarily better.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 55 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2029
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: * Written informed consent will be obtained to participate in the study, and HIPAA authorization for the release of personal health information. * Subject is willing and able to comply with study procedures based on the judgment of the investigator or protocol designee, including randomization. * Age ≥ 18 years at the time of consent. * ECOG Performance Status of 0-2. * Histological confirmation of cutaneous melanoma or melanoma of unknown primary. * AJCC stage IIIB/IVa resectable disease that is measurable by iRECIST criteria. * Adequate hematologic, renal, hepatic, and heart function Exclusion Criteria: * Prior treatment with PD-1 Programmed cell death Protein 1 (PD-1) and Cytotoxic T-lymphocyte Antigen 4 (CTLA-4). * Has an active autoimmune disease that requires systemic treatment with the use of disease-modifying agents or immunosuppressive drugs. For corticosteroids, up to 10 mg of prednisone daily, or an equivalent dose, is permitted. Hormone replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. * Any condition, including laboratory abnormalities, that, in the opinion of the investigator, places the subject at unacceptable risk if he/she were to participate in the study. This includes, but is not limited to, serious medical conditions or psychiatric illnesses that are likely to interfere with participation in this clinical study.
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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
1 site. 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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Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
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