Intradermal Ipilimumab and Nivolumab in High Risk Stage II Melanoma

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.

Trial Details

NCT ID
NCT06240143
Phase
PHASE1 / PHASE2
Sponsor
The Netherlands Cancer Institute
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • Ipilimumab
  • Nivolumab
Locations (sample)
  • Amsterdam, Netherlands|52.37403,4.88969
  • Amsterdam, Netherlands|52.37403,4.88969
  • Groningen, Netherlands|53.21917,6.56667
  • Leiden, Netherlands|52.15833,4.49306
  • Rotterdam, Netherlands|51.9225,4.47917

Key Eligibility Criteria

  • Men and women, at least 18 years of age;
  • World Health Organization (WHO) Performance Status 0 or 1;
  • Histologically confirmed, stage pT3-4 cutaneous melanoma (Breslow thickness \>2.0mm; according to AJCC criteria 8th edition);
  • Having ≥44% risk for SN positivity as assessed by the MIA Sentinel Node Metastasis Risk prediction tool (melanomarisk.org.au/SNLForm)1;

For full eligibility, visit ClinicalTrials.gov.

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