OncoMatch/Clinical Trials/NCT06365619
Neoadjuvant Ipilimumab/Nivolumab for Patients With Recurrent, High Risk, Resectable Melanoma
Is NCT06365619 recruiting? Yes, currently enrolling (May 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
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
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