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

Primary Purpose

Melanoma

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

MGA271

About this trial

This is an interventional basic science trial for Melanoma focused on measuring Melanoma, Accessible tumors, B7-H3 positive tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

UCLA Hematology-Oncology Clinic
Moffitt Cancer Center
The University of Chicago
Massachusetts General Hospital Cancer Center
Carolina BioOncology Institute
Hospital of the University of Pennsylvania/Abramson Cancer Center
Sarah Cannon Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MGA271

Arm Description

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

Outcomes

Primary Outcome Measures

Mechanism of Action

Exploratory analyses from immunohistochemistry (IHC) and flow cytometry testing to determine the effect of MGA271 on tumor cells.

Secondary Outcome Measures

Full Information

NCT ID

NCT01918930

First Posted

July 30, 2013

Last Updated

February 4, 2022

Sponsor

MacroGenics

Collaborators

Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01918930

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Terminated

Why Stopped

Unable to accrue as planned for optional biopsies

Study Start Date

July 2013 (undefined)

Primary Completion Date

October 2016 (Actual)

Study Completion Date

October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

MacroGenics

Collaborators

Massachusetts General Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma

Keywords

Melanoma, Accessible tumors, B7-H3 positive tumors

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MGA271

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

MGA271

Intervention Description

MGA271 anti-B7-H3 monoclonal antibody

Primary Outcome Measure Information:

Title

Mechanism of Action

Description

Exploratory analyses from immunohistochemistry (IHC) and flow cytometry testing to determine the effect of MGA271 on tumor cells.

Time Frame

up to 50 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chief Medical Officer

Organizational Affiliation

MacroGenics

Official's Role

Study Director

Facility Information:

Facility Name

UCLA Hematology-Oncology Clinic

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

Moffitt Cancer Center

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

The University of Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

Massachusetts General Hospital Cancer Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Carolina BioOncology Institute

City

Huntersville

State/Province

North Carolina

ZIP/Postal Code

28078

Country

United States

Facility Name

Hospital of the University of Pennsylvania/Abramson Cancer Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Sarah Cannon Research Institute

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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