RecruitingPhase 2NCT06365619

Neoadjuvant Ipilimumab/Nivolumab for Patients With Recurrent, High Risk, Resectable Melanoma

Phase II Study of Neoadjuvant Ipilimumab/Nivolumab for Patients With Recurrent, High Risk, Resectable Melanoma

Sponsor

University of Utah

Enrollment

25 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

Melanoma

Summary

The goal of this clinical trial is to study the impact of Neoadjuvant ipilimumab and nivolumab for melanoma patients that had recurrence during or after adjuvant anti-PD-1 therapy. Participants will receive 2 cycles of treatment prior to their standard of care surgery. After surgery participants will receive standard of care adjuvant therapy and be followed for response.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether two immunotherapy drugs — ipilimumab and nivolumab — given before surgery can improve outcomes for people with melanoma (skin cancer) that has come back and can potentially be removed surgically. **You may be eligible if...** - You are 18 or older - You have been diagnosed with advanced melanoma (Stage IIIB–D or Stage IV) that has returned and is considered removable by a surgeon - Your recurrence was confirmed by a biopsy while receiving a specific type of immunotherapy (anti-PD-1 therapy) - You have acceptable organ function and performance status **You may NOT be eligible if...** - Your melanoma is in the eye (uveal melanoma) or originated in a mucous membrane - You have active autoimmune disease requiring treatment - You have received certain prior treatments that would conflict with the study drugs - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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