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

NCT04274816 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2020-02-18

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Tremelimumab

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).

Sponsors & Collaborators

  • A.J.M. van den Eertwegh

    lead OTHER

Principal Investigators

  • Tanja D de Gruijl · Amsterdam UMC, location VUmc

  • Alfons JM van den Eertwegh · Amsterdam UMC, location VUmc

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-10
Primary Completion
2014-02-27
Completion
2014-02-27

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04274816 on ClinicalTrials.gov