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.

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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.

Contacts and locations

Locations

  • Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599, United States

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