OncoMatch/Clinical Trials/NCT06365619
Neoadjuvant Ipilimumab/Nivolumab for Patients With Recurrent, High Risk, Resectable Melanoma
Is NCT06365619 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Ipilimumab and Nivolumab for melanoma.
Treatment: Ipilimumab · Nivolumab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Cancer type
Melanoma
Disease stage
Required: Stage IIIB, IIIC, IIID, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-1 therapy — adjuvant
Recurrent disease at eligibility must have been confirmed with biopsy while receiving or within 3 months of completion of adjuvant anti-PD1 therapy
Cannot have received: systemic anti-cancer therapy
Prior systemic anti-cancer therapy ≤ 14 days or within five half-lives prior to starting study treatment, whichever is shorter
Cannot have received: radiation therapy
Prior radiotherapy 45 days prior to the first dose of study treatment
Lab requirements
Blood counts
ANC ≥ 1500/mm3; Platelet count ≥ 100,000/mm3; Hemoglobin ≥ 10 g/dL
Kidney function
Estimated creatinine clearance ≥ 50 mL/min by Cockcroft-Gault formula
Liver function
Total Bilirubin ≤ 1.5x institutional ULN; AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN (≤ 5x ULN if liver metastases)
Adequate organ function as defined as: Hematologic: ANC ≥ 1500/mm3, Platelet count ≥ 100,000/mm3, Hemoglobin ≥ 10 g/dL; Hepatic: Total Bilirubin ≤ 1.5x institutional ULN, AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN (≤ 5x ULN if liver metastases); Renal: Estimated creatinine clearance ≥ 50 mL/min by Cockcroft-Gault formula
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Huntsman Cancer Institute · Salt Lake City, Utah
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06365619 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic anti-cancer therapy, radiation therapy disqualifies patients from enrollment.
What disease stage is eligible?
Stage IIIB or IIIC or IIID or IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages