Tissue Procurement Substudy for Participants in Study CP-MGA271-01

Study Overview
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Brief Summary
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The purpose of this study is to gain a better understanding about how the study drug MGA271 works. No test drug will be given in this study. Patients with easily accessible tumors at the screening visit for participation in Study CP-MGA271-01 will be asked to participate in this substudy. Patients will undergo two excisional biopsies, punch biopsies, or core needle biopsies.

Detailed Description
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Patients with easily accessible tumors (generally, metastatic deposits involving skin, subcutaneous tissues, or peripheral lymph node whose excision would not require general anaesthesia or the invasion of a body cavity) at the screening visit for participation in Study CP-MGA271-01 (the main study) will be asked to participate in this substudy. After providing appropriate informed consent, patients will undergo excisional biopsy, punch biopsy, or core needle biopsy of the accessible tumor prior to receiving study drug in the main study and then again after the first cycle of study drug is completed. Some of the biopsy tissue will be sent to a central laboratory for research purposes. The central lab will analyze the tissue to see what effects that the study drug might have on tumors.

Official Title
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A Tissue Procurement and Examination Substudy of Study CP-MGA271-01 (NCT01391143)

Conditions
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Melanoma

Intervention / Treatment
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* Biological: MGA271


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Qualified, by meeting all inclusion and exclusion criteria, for participation in Study CP-MGA271-01. Must have provided informed consent to participate in Study CP-MGA271-01. Must have accessible tumors (generally speaking, metastatic deposits involving skin, subcutaneous tissue, or peripheral lymph node whose excision, punch biopsy, or core needle biopsy would not require general anaesthesia or the invasion of a body cavity). Willing to undergo two minor surgical procedures with no expectation of personal benefit Have provided Informed Consent for this substudy as indicated by a signature on an approved consent document obtained from the patient or his/her legally authorized representative Exclusion Criteria: Any medical condition that would contraindicate the use of local or locoregional anaesthesia, or conscious sedation for the intended minor surgical procedure. Any medical condition (eg. skin disease or bleeding diathesis) that would hinder wound healing following a minor surgical procedure. Dementia or altered mental status that would preclude understanding and rendering of informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MGA271<br>MGA271 (administered in main study CP-MGA271-01) | Biological: MGA271<br>* MGA271 anti-B7-H3 monoclonal antibody<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanism of Action | Exploratory analyses from immunohistochemistry (IHC) and flow cytometry testing to determine the effect of MGA271 on tumor cells. | up to 50 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Accessible tumors, B7-H3 positive tumors, Melanoma