Intradermal Ipilimumab and Nivolumab in High Risk Stage II Melanoma

Sponsor
The Netherlands Cancer Institute
Study ID
NCT06240143
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Mar 8, 2024
Status verified
Nov 2024
Primary completion
Jul 31, 2029
Completion
Mar 31, 2034

Study Design

Enrollment
96 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: A: 2x low dose intradermal
    2 cycles of intradermal ipilimumab 0.5 mg + nivolumab 1 mg every 3 weeks
  • Experimental: B: 6x low dose intradermal
    6 cycles of intradermal ipilimumab 0.5 mg + nivolumab 1 mg every week
  • Experimental: C: 2x higher dose intradermal
    2 cycles of intradermal ipilimumab 10 mg + nivolumab 20 mg every 3 weeks
  • Experimental: D: intradermal + intravenous
    intradermal ipilimumab + nivolumab according to the optimal intradermal regimen plus 2 cycles of intravenous nivolumab 240mg every 3 weeks

Primary Outcome Measure

Feasibility of application of studytreatment [ Time Frame: Up to 100 days after treatment ]

Central Contacts

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