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

University of Utah1 site in 1 country25 target enrollmentFebruary 1, 2026

ConditionsMelanoma

InterventionsIpilimumab Nivolumab

Overview

Phase: Phase 2
Intervention: Ipilimumab
Conditions: Melanoma
Sponsor: University of Utah
Enrollment: 25
Locations: 1
Primary Endpoint: Rate of pathologic response rate (pCR, mCR/nCR, or pPR) at the time of surgery.
Status: Recruiting
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

February 1, 2026

End Date

August 1, 2029

Last Updated

3 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Utah

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects aged ≥ 18 years.
•Histologically confirmed Stage IIIB-D or Stage IV recurrent metastatic melanoma that is resectable or borderline resectable as determined by a Surgical Oncologist.
•Recurrent disease at eligibility must have been confirmed with biopsy while receiving or within 3 months of completion of adjuvant anti-PD1 therapy.
•ECOG Performance Status ≤
•Adequate organ function as defined as:
•Hematologic:
•Absolute neutrophil count (ANC) ≥ 1500/mm3
•Platelet count ≥ 100,000/mm3
•Hemoglobin ≥ 10 g/dL
•Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN)

Exclusion Criteria

•Receiving other investigational agents currently or within 28 days of study treatment.
•Prior systemic anti-cancer therapy ≤ 14 days or within five half-lives prior to starting study treatment, whichever is shorter.
•Prior radiotherapy 45 days prior to the first dose of study treatment.
•Major surgery 4 weeks prior to starting study drug or who have not fully recovered from major surgery.
•Active infection requiring the use of systemic antibiotics.
•Systemic steroid therapy greater than physiologic equivalent (10mg prednisone/day) or any other form of systemic immunosuppressive therapy within 7 days prior to registration.
•Active secondary malignancy, unless the malignancy is not expected to interfere with the evaluation of safety
•Known brain metastases or cranial epidural disease.
•Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions:
•-Cardiovascular disorders:

Arms & Interventions

Treatment: All Patients

Neoadjuvant Ipilimumab and Nivolumab

Intervention: Ipilimumab

Treatment: All Patients

Neoadjuvant Ipilimumab and Nivolumab

Intervention: Nivolumab

Outcomes

Primary Outcomes

Rate of pathologic response rate (pCR, mCR/nCR, or pPR) at the time of surgery.

Time Frame: 2 months

Assess the pathologic response rate (pRR) at the time of surgery after two doses of neoadjuvant Ipilimumab and Nivolumab for patients that have recurred while receiving/recently completed adjuvant anti-PD1 therapy.

Secondary Outcomes

Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE, version 5.0), seriousness, duration, and relationship to study treatment.(2 months)
Rate of Event Free Survival (EFS).(11 years)
Rate of Overall Survival (OS).(11 years)
Rate of adverse events that occur within 30 days post-surgery.(30 days)
Objective response rate (ORR) defined as the proportion of subjects achieving a confirmed PR and CR as defined by RECIST 1.1 prior to surgical resection.(11 years)