OncoMatch/Clinical Trials/NCT06240143
Intradermal Ipilimumab and Nivolumab in High Risk Stage II Melanoma
Is NCT06240143 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Ipilimumab and Nivolumab for melanoma.
Treatment: Ipilimumab · Nivolumab · Nivolumab — This open label, single country trial will test if local injection of low-dose ipilimumab and nivolumab, is safe and reduces the sentinel node positivity in high-risk stage II melanoma patients.
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Disease stage
Required: Stage PT3, PT4
Performance status
WHO 0–1
Prior therapy
Cannot have received: immunotherapy targeting CTLA-4, PD-1, PD-L1 or LAG-3
No prior immunotherapy targeting CTLA-4, PD-1, PD-L1 or LAG-3
Cannot have received: BRAF inhibitor
No prior targeted therapy with BRAF/MEK inhibition
Cannot have received: MEK inhibitor
No prior targeted therapy with BRAF/MEK inhibition
Cannot have received: radiation therapy
Exception: targeting the affected lymph node region(s)
Prior radiotherapy targeting the affected lymph node region(s)
Cannot have received: surgery
Exception: prior sentinel node procedure or lymph node dissection in the affected lymph node region(s)
Prior surgery, including prior sentinel node procedure or lymph node dissection, in the affected lymph node region(s)
Lab requirements
Blood counts
WBC ≥2.0x10^9/L, neutrophils ≥1.5x10^9/L, platelets ≥100x10^9/L, hemoglobin ≥5.5 mmol/L
Kidney function
creatinine ≤1.5x upper limit of normal (ULN)
Liver function
AST ≤1.5x ULN, ALT ≤1.5x ULN, bilirubin ≤1.5x ULN (except for subjects with Gilbert syndrome who must have a total bilirubin <3.0 mg/dL)
Screening laboratory values must meet the following criteria: WBC ≥2.0x10^9/L, neutrophils ≥1.5x10^9/L, platelets ≥100x10^9/L, hemoglobin ≥5.5 mmol/L, creatinine ≤1.5xupper limit of normal (ULN), AST ≤1.5x ULN, ALT ≤1.5x ULN, bilirubin ≤1.5x ULN (except for subjects with Gilbert syndrome who must have a total bilirubin <3.0 mg/dL); LDH level ≤ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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