A Phase 2 interventional study of Ipilimumab and Nivolumab in Melanoma, sponsored by University of Utah. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by University of Utah · Phase 2, Interventional, and Treatment
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.
3,006 studies on the registry are indexed under Melanoma; 519 are open to participants now.
This study's planned enrollment of 25 is below the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →University of Utah is the lead sponsor of 970 studies on the registry; 179 are open to participants now.
Of its 107 completed or terminated interventional studies of FDA-regulated products, 62 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adequate organ function as defined as:
Hematologic:
Hepatic:
AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN
Renal:
For subjects of childbearing potential: Negative pregnancy test or evidence of post-menopausal status or evidence of permanent surgical sterilization. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
Subjects \< 50 years of age:
Subjects ≥ 50 years of age:
Exclusion Criteria:
Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions:
Cardiovascular disorders:
HIV infection with a detectable viral load within 6 months of the anticipated start of treatment.
--Note: Subjects on effective antiretroviral therapy with an undetectable viral load within 6 months of the anticipated start of treatment are eligible for this trial.
Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination, radiographic findings, and TB testing in line with local practice), hepatitis B (positive HBV surface antigen (HBsAg) result), or hepatitis C.
--Note: Subjects with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Subjects positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
Neoadjuvant Ipilimumab and Nivolumab
Drug: Ipilimumab · Drug: Nivolumab
Two cycles of neoadjuvant ipilimumab prior to surgical resection.
two cycles of neoadjuvant nivolumab prior to surgical resection.
Rate of pathologic response rate (pCR, mCR/nCR, or pPR) at the time of surgery.
Assess the pathologic response rate (pRR) at the time of surgery after two doses of neoadjuvant Ipilimumab and Nivolumab for patients with resectable disease that have recurred after receiving systemic anti-PD1 therapy.
Time frame: 2 months
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.
Assess the safety and tolerability of Ipilimumab and Nivolumab in the study population.
Time frame: 2 months
Rate of adverse events that occur within 30 days post-surgery.
Assess the impact of neoadjuvant ipi/nivo on morbidity of definitive surgery.
Time frame: 30 days
Rate of Event Free Survival (EFS).
Assess EFS in the study population.
Time frame: 11 years
Rate of Overall Survival (OS).
Assess OS in this study population.
Time frame: 11 years
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.
Determine RECIST 1.1 response rate (confirmed CR and PR) before surgical resection and to evaluate associations between radiographic and pathologic response rate and event free survival/overall survival.
Time frame: 11 years
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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University of Utah