NCT01918930

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2013

Typical duration for phase_1

Geographic Reach
1 country

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 8, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

February 8, 2022

Status Verified

January 1, 2022

Enrollment Period

3.3 years

First QC Date

July 30, 2013

Last Update Submit

February 4, 2022

Conditions

Melanoma

Keywords

MelanomaAccessible tumorsB7-H3 positive tumors

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

MGA271

EXPERIMENTAL

MGA271 (administered in main study CP-MGA271-01)

Biological: MGA271

Interventions

MGA271BIOLOGICAL

MGA271 anti-B7-H3 monoclonal antibody

MGA271

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

UCLA Hematology-Oncology Clinic

Los Angeles, California, 90095, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Carolina BioOncology Institute

Huntersville, North Carolina, 28078, United States

Location

Hospital of the University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Chief Medical Officer

    MacroGenics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2013

First Posted

August 8, 2013

Study Start

July 1, 2013

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

February 8, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(7)