Actively Recruiting
Neoadjuvant Ipilimumab/Nivolumab for Patients With Recurrent, High Risk, Resectable Melanoma
Led by University of Utah · Updated on 2026-01-29
25
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Neoadjuvant Ipilimumab/Nivolumab for Patients With Recurrent, High Risk, Resectable Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed Stage IIIB-D or Stage IV recurrent metastatic melanoma that is resectable or borderline resectable
- Recurrent disease confirmed by biopsy during or within 3 months after adjuvant anti-PD-1 therapy
- ECOG Performance Status 0 or 1
- Adequate blood counts and organ function including hematologic, hepatic, and renal criteria
- For subjects of childbearing potential, negative pregnancy test or post-menopausal status or permanent surgical sterilization
- Use of effective contraception if of childbearing potential or partner is of childbearing potential
- Availability of archival tissue or willingness to undergo fresh biopsy
- Recovery to baseline or Grade 1 or less from prior treatment toxicities unless clinically nonsignificant and stable
- Ability to provide informed consent and willingness to sign consent form
You will not qualify if you...
- Receiving other investigational agents currently or within 28 days before study treatment
- Prior systemic anti-cancer therapy within 14 days or five half-lives before study treatment
- Radiotherapy within 45 days before first study dose
- Major surgery within 4 weeks before starting study drug or not fully recovered
- Active infections requiring systemic antibiotics
- Use of systemic steroids above physiologic dose or immunosuppressive therapy within 7 days before registration
- Active secondary malignancy that may interfere with safety evaluation
- Known brain metastases or cranial epidural disease
- Significant uncontrolled illnesses including serious heart conditions, recent stroke or heart attack, prolonged QTc, uncontrolled hypertension
- Conditions preventing safe participation such as infection or inability to swallow medication
- HIV infection with detectable viral load within 6 months before treatment (except controlled on therapy)
- Active tuberculosis, hepatitis B or C infection (except resolved or controlled cases)
- Medical, psychiatric, or cognitive conditions limiting ability to comply with protocol
- History of severe hypersensitivity to study drugs or their components
- Use of prohibited medications without appropriate washout period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
K
Kaitlin Stephens
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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