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

NCT ID: NCT06365619

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2029-08-31

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.

Conditions

Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment: All Patients

Neoadjuvant Ipilimumab and Nivolumab

Group Type: EXPERIMENTAL

Ipilimumab

Intervention Type: DRUG

Two cycles of neoadjuvant ipilimumab prior to surgical resection.

Nivolumab

Intervention Type: DRUG

two cycles of neoadjuvant nivolumab prior to surgical resection.

Interventions

Ipilimumab

Two cycles of neoadjuvant ipilimumab prior to surgical resection.

Intervention Type: DRUG

Nivolumab

two cycles of neoadjuvant nivolumab prior to surgical resection.

Intervention Type: DRUG

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 ≤ 1.
• Adequate organ function as defined as:

• Hematologic:

• Absolute neutrophil count (ANC) ≥ 1500/mm3
• Platelet count ≥ 100,000/mm3
• Hemoglobin ≥ 10 g/dL
• Hepatic:

• Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN)
• AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN ----Subjects with liver metastases will be allowed to enroll with AST and ALT levels ≤ 5 x ULN.
• Renal:

• Estimated creatinine clearance ≥ 50 mL/min by Cockcroft-Gault formula:
• 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:

• Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and
• Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution
• Subjects ≥ 50 years of age:

• Amenorrheic for ≥ 12 months following cessation of all exogenous hormonal treatments; or
• Had radiation-induced menopause with last menses >1 year ago; or
• Had chemotherapy-induced menopause with last menses >1 year ago
• Subjects of childbearing potential and subjects with a sexual partner of childbearing potential must agree to use a highly effective method of contraception as described in Section 5.3.1.
• Subject has adequate archival tissue or agrees to undergo a fresh tissue biopsy if sufficient archival tissue is unavailable.
• Recovery to baseline or ≤ Grade 1 CTCAE v5 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy per the treating investigator.
• Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.

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:

• Congestive heart failure New York Heart Association Class III or IV, unstable angina pectoris, serious cardiac arrhythmias.
• Stroke (including transient ischemic attack [TIA]), myocardial infarction (MI), or other ischemic events, or thromboembolic event (eg, deep venous thrombosis, pulmonary embolism) within 3 months before the first dose.
• QTc prolongation defined as a QTcF > 500 ms.
• Known congenital long QT.
• Left ventricular ejection fraction < 55%.
• Uncontrolled hypertension defined as ≥ 140/90 as assessed from the mean of three consecutive blood pressure measurements taken over 10 minutes.
• Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, [subjects may not receive the drug through a feeding tube], social/psychological issues, etc.)
• 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.

• Medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study.
• Known prior severe hypersensitivity to investigational product (IP) or any component in its formulations (NCI CTCAE v5.0 Grade ≥ 3).
• Subjects taking prohibited medications as described in Section 6.7.2. A washout period of prohibited medications for a period of at least five half-lives or as clinically indicated should occur before the start of treatment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Siwen Hu-Lieskovan, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Huntsman Cancer Institute

Locations

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kaitlin Stephens

Role: CONTACT

kaitlin.stephens@hci.utah.edu

801-213-8494

Facility Contacts

Kaitlin Stephens

Role: primary

Kaitlin.Stephens@hci.utah.edu

801-213-8494

Other Identifiers

HCI168525

Identifier Type: -

Identifier Source: org_study_id