Intradermal Injection of Anti-CTLA-4 in Patients With Stage I/II Melanoma

Sponsor
A.J.M. van den Eertwegh
Study ID
NCT04274816
Phase
PHASE1
Status
Completed

Conditions

  • Cutaneous Melanoma

Eligibility Criteria

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

Interventions

  • Tremelimumab — DRUG
    Intradermal injection of tremelimumab 7 days prior to sentinel node biopsy, with escalating doses of 2, 5, 10 or 20 mg tremelimumab (3 patients per dose level with an expansion at the optimal dose level with an additional 5 patients).

Study Details

This study evaluates the clinical safety and tolerability, and the immunological effects of local intradermal injection of tremelimumab in patients with clinical stage I/II melanoma patients undergoing a sentinel node biopsy (SNB). Patients will be treated by local intradermal injections around the excision site of the primary tumor with escalating doses of 2, 5, 10 or 20 mg tremelimumab.

Key Dates

Start date
Jul 10, 2012
Status verified
Feb 2020
Primary completion
Feb 27, 2014
Completion
Feb 27, 2014

Study Design

Enrollment
13 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tremelimumab
    Intradermal injection of tremelimumab at the primary melanoma excision site, 7 days prior to sentinel node biopsy (SNB), with escalating doses of 2, 5, 10 or 20 mg tremelimumab (3 patients per dose level with an expansion at the optimal dose level with an additional 5 patients).

Primary Outcome Measure

Number of participants with adverse events as assessed by CTCAE V3.0 [ Time Frame: From the time of injection until 28 days after injection of tremelimumab ]

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