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



Status:Recruiting
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:July 2013
End Date:February 2016
Contact:Jan Baughman, MPH
Email:baughmanj@macrogenics.com
Phone:650 624-2676

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

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.

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.

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.
We found this trial at
7
sites
55 Fruit St
Boston, Massachusetts 02114
(617) 724-4000
Principal Investigator: Greg Cote, M.D.
Phone: 617-724-4800
Massachusetts General Hospital Cancer Center An integral part of one of the world
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Russell Szmulewitz, M.D.
Phone: 773-702-9136
University of Chicago One of the world's premier academic and research institutions, the University of...
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9801 W. Kincey Ave
Huntersville, North Carolina 28078
704-947-6599
Principal Investigator: John D Powderly, M.D.
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Los Angeles, California 90095
Principal Investigator: Bartosz Chmielowski, M.D., Ph.D.
Phone: 310-829-5471
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Los Angeles, CA
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Principal Investigator: Howard Burris, M.D.
Phone: 615-339-4214
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Nashville, TN
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Philadelphia, Pennsylvania 19104
Principal Investigator: Roger Cohen, M.D.
Phone: 215-662-7452
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Philadelphia, PA
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Tampa, Florida 33612
Principal Investigator: Jeffrey Weber, M.D., Ph.D.
Phone: 813-745-8352
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Tampa, FL
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