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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-10

Study Completion Date

2014-02-27

Brief Summary

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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.

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Detailed Description

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Although of limited therapeutic value, the SLN procedure has proven a useful prognostic tool for the assessment of melanoma relapse and mortality risk. Moreover, the SLN is of great value for the assessment of immunological interventions for melanoma. Since early melanoma development is accompanied by impaired immune effector functions primarily in the SLN, there is a strong rationale for therapeutic immune modulation of the SLN aimed at strengthening cellular immune functions.

The investigator now propose a phase I dose escalation study to administer intradermally a single clinical dose of tremelimumab/anti-CTLA-4 locally at the primary tumor excision site of patients with clinical stage I/II melanoma. Such a single local administration aimed at conditioning of the SLN should allow for the use of relatively low anti-CTLA-4 dosages without excess risk of autoimmune effects.

Conditions

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Cutaneous Melanoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Seven days before undergoing a SNB, clinical stage I/II melanoma patients will be treated with an intradermal injection of tremelimumab, around the excision site of the primary tumor. Escalating doses of 2, 5, 10, or 20 mg of tremelimumab will be given (3 patients per dose level with an expansion at the optimal dose level with an additional 5 patients).

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Tremelimumab

Intervention Type 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).

Interventions

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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).

Intervention Type DRUG

Other Intervention Names

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Anti-CTLA-4

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* Clinical stage I/II melanoma patients, planned to undergo a sentinel lymph node biopsy (SNB)
* ECOG performance status 0 or 1
* White blood count (WBC) ≥ 3 x10\^9/L
* Platelet count ≥ 100 x10\^9/L
* Hemoglobin ≥ 6.5 mmol/L
* Serum creatinine ≤ 2.5 x ULN
* Total serum bilirubin, AST, ALT and LDH ≤ 2x ULN

Exclusion Criteria

* Non-oncology vaccine therapy used for prevention of infectious diseases (up-to) 4 weeks prior and/r 8 weeks after any dose of tremelimumab
* Prior treatment with a CD137 agonist or CTLA-4 inhibitor or agonist
* Uncontrolled infectious disease including negative testing for HIV, HBV, HCV
* Autoimmune disease

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No