MelanomaPhase 1NCT01918930
Tissue Procurement Substudy for Participants in Study CP-MGA271-01
A Phase 1 study testing MGA271 in people with Melanoma, run by MacroGenics at 7 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- MGA271
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 7 sitesUnited States
- Study dates
- Jul 2013to Oct 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
The University of Chicago
Chicago, Illinois, 60637
Carolina BioOncology Institute
Huntersville, North Carolina, 28078
UCLA Hematology-Oncology Clinic
Los Angeles, California, 90095
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Hospital of the University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: 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.
Read the 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.
- Conditions
- Melanoma
- Being tested
- MGA271
- Keywords
- Melanoma, Accessible tumors, B7-H3 positive tumors
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MGA271Biological
MGA271 anti-B7-H3 monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| MGA271 | Experimental | MGA271 (administered in main study CP-MGA271-01) Receives: Biological: MGA271 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanism of Action
Exploratory analyses from immunohistochemistry (IHC) and flow cytometry testing to determine the effect of MGA271 on tumor cells.
Measured: up to 50 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionOct 2016
- Study completionOct 2016
Why it stopped: Unable to accrue as planned for optional biopsies
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- MacroGenics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study director, MacroGenics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918930
- Sponsor's protocol ID
- CP-MGA271-01a
- Status last verified
- Jan 2022
- First submitted
- 30 Jul 2013
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Tissue Procurement and Examination Substudy of Study CP-MGA271-01 (NCT01391143)
- ClinicalTrials.gov ID
- NCT01918930
- Acronym / sponsor ID
- CP-MGA271-01a
- Conditions
- Melanoma
- Keywords
- Melanoma, Accessible tumors, B7-H3 positive tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to accrue as planned for optional biopsies
- Enrolment
- 6 participants (actual)
- Lead sponsor
- MacroGenicsIndustry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital
- Study start
- Jul 2013
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 8 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MGA271 | Experimental | Biological: MGA271MGA271 (administered in main study CP-MGA271-01) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MGA271MGA271 anti-B7-H3 monoclonal antibody | Biological | MGA271 |
Primary outcome
Mechanism of Action
Time frame: up to 50 days
Exploratory analyses from immunohistochemistry (IHC) and flow cytometry testing to determine the effect of MGA271 on tumor cells.
Results and safety
The study was stopped early (reason given: Unable to accrue as planned for optional biopsies). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chief Medical Officer study director
MacroGenics
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MGA271 in people with Melanoma, run by MacroGenics at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Unable to accrue as planned for optional biopsies). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mechanism of Action (time frame: up to 50 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022; AzTrials last refreshed its copy on 30 Oct 2026.