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

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01918930
• Other study ID #: CP-MGA271-01a
• Status: Terminated
• Phase: Phase 1
• Start date: July 2013
• Est. completion date: October 2016

Study information

• Verified date: January 2022
• Source: MacroGenics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma

Intervention

Biological:
• MGA271
MGA271 anti-B7-H3 monoclonal antibody

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts
United States	The University of Chicago	Chicago	Illinois
United States	Carolina BioOncology Institute	Huntersville	North Carolina
United States	UCLA Hematology-Oncology Clinic	Los Angeles	California
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Hospital of the University of Pennsylvania/Abramson Cancer Center	Philadelphia	Pennsylvania
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
MacroGenics	Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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