Neoadjuvant Ipilimumab/Nivolumab for Patients With Recurrent, High Risk, Resectable Melanoma (NCT06365619) | Clinical Trial Compass
RecruitingPhase 2
Neoadjuvant Ipilimumab/Nivolumab for Patients With Recurrent, High Risk, Resectable Melanoma
United States25 participantsStarted 2026-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
-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.
-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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 2 trial combining two immunotherapy drugs — ipilimumab and nivolumab — before surgery, what is currently known about the safety profile of this combination, and what side effects should I be prepared for?
2The trial is measuring how well the tumor responds before surgery — called a pathologic response — so how would my doctors assess whether my tumor is responding, and what happens if it doesn't respond well enough?
3My melanoma is described as 'recurrent and high risk' — can you help me understand how my specific situation fits those criteria, and whether this neoadjuvant approach is more appropriate for me than going straight to surgery followed by treatment?
4If I enroll and receive ipilimumab and nivolumab before surgery, how might that affect the surgery itself, including timing, complexity, or recovery?
5Are there standard treatment options I should consider first before a trial like this, and how does the evidence for those compare to what we know so far from Phase 2 studies of this pre-surgery immunotherapy approach?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of pathologic response rate (pCR, mCR/nCR, or pPR) at the time of surgery.