Clinical Stage III Nodal or Intransit Disease or Resectable Stage IV MelanomaNCT02716077

Early FDG PET in Melanoma

A study testing FDG PET/CT imaging in people with Clinical Stage III Nodal or Intransit Disease or Resectable Stage IV Melanoma, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Adult patients with histologically proven melanoma who will be treated with pembrolizumab will undergo FDG PET/CT scan as an early evaluation of response to therapy. Changes in FDG uptake will be correlated with lab and pathology results. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Clinical Stage III Nodal or Intransit Disease or Resectable Stage IV Melanoma
What is being tested?: FDG PET/CT imaging
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteUnited States
Study dates: Mar 2016to Mar 2021
Phase: Interventional
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

Adult patients, at least 18 years of age
History of histologically confirmed melanoma as assessed per medical record review.
Eligible for the trial UPCC #01615, "A Phase Ib Tissue Collection Study of Pembrolizumab (MK-3475) in Subjects with Resectable Advanced Melanoma."
Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.

Who cannot join

Females who are pregnant or breast-feeding at the time of screening will not be eligible for this study. Female participants of child-bearing potential will have a urine or serum pregnancy test at the time of the screening visit.
Inability to tolerate imaging procedures in the opinion of the investigator or treating physician.
Serious or unstable medical or psychological conditions that, in the opinion of the investigator would compromise the subject's safety or successful participation in the study.
Ineligible for the trial UPCC #01615, "A Phase Ib Tissue Collection Study of Pembrolizumab (MK-3475) in Subjects with Resectable Advanced Melanoma."
Only individuals (aged 18 or over) who can understand and give informed consent will be eligible to participate in this study. Individuals who are considered to be mentally disabled will not be recruited for this study. All subjects must be able to give informed consent. We will not be using specific methods to assess decisional capacity. Economically disadvantaged persons will not be vulnerable to undue influence, as this study offers no compensation. All individuals will be told that their choice regarding study participation will in no way change their access to clinical care. This should negate any undue influence or coercion. Children, fetuses, neonates, or prisoners are not included in this research study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Early FDG PET/CT Imaging as a Measure of Response in Patients With Melanoma on Pembrolizumab.

Conditions: Clinical Stage III Nodal or Intransit Disease or Resectable Stage IV Melanoma
Being tested: FDG PET/CT imaging

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FDG PET/CT imagingRadiation

Study groups in NCT02716077
Study group	Role	What they receive
Single arm	Experimental	FDG PET/CT scan pre-therapy Receives: Radiation: FDG PET/CT imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

disease-free survival
Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2016Mar 2021

First posted23 Mar 2016 (estimated)
Study startMar 2016
Primary completionMar 2021
Study completionMar 2021

Why it stopped: low recruitment due to changing treatment landscape for subject population

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Clinical Stage III Nodal or Intransit Disease or Resectable Stage IV 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 N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02716077
Sponsor's protocol ID: UPCC 11615
Status last verified: Jul 2021
First submitted: 14 Mar 2016
Last updated: 23 Jul 2021
Results posted: No
Data monitoring committee: Yes

Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Early FDG PET/CT Imaging as a Measure of Response in Patients With Melanoma on Pembrolizumab.
ClinicalTrials.gov ID: NCT02716077
Acronym / sponsor ID: UPCC 11615
Conditions: Clinical Stage III Nodal or Intransit Disease or Resectable Stage IV Melanoma
Study type: Interventional
Recruitment status: TerminatedReason stopped: low recruitment due to changing treatment landscape for subject population
Enrolment: 6 participants (actual)
Lead sponsor: Abramson Cancer Center at Penn MedicineUniversity, hospital or other
Study start: Mar 2016
Primary completion: Mar 2021 (actual)
Study completion: Mar 2021 (actual)
First posted: 23 Mar 2016 (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.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Number of arms: 1

Arm	Type	Receives
Single arm	Experimental	Radiation: FDG PET/CT imagingFDG PET/CT scan pre-therapy

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Adult patients, at least 18 years of age
History of histologically confirmed melanoma as assessed per medical record review.
Eligible for the trial UPCC #01615, "A Phase Ib Tissue Collection Study of Pembrolizumab (MK-3475) in Subjects with Resectable Advanced Melanoma."
Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.

Key exclusion criteria (5 listed)

Females who are pregnant or breast-feeding at the time of screening will not be eligible for this study. Female participants of child-bearing potential will have a urine or serum pregnancy test at the time of the screening visit.
Inability to tolerate imaging procedures in the opinion of the investigator or treating physician.
Serious or unstable medical or psychological conditions that, in the opinion of the investigator would compromise the subject's safety or successful participation in the study.
Ineligible for the trial UPCC #01615, "A Phase Ib Tissue Collection Study of Pembrolizumab (MK-3475) in Subjects with Resectable Advanced Melanoma."
Only individuals (aged 18 or over) who can understand and give informed consent will be eligible to participate in this study. Individuals who are considered to be mentally disabled will not be recruited for this study. All subjects must be able to give informed consent. We will not be using specific methods to assess decisional capacity. Economically disadvantaged persons will not be vulnerable to undue influence, as this study offers no compensation. All individuals will be told that their choice regarding study participation will in no way change their access to clinical care. This should negate any undue influence or coercion. Children, fetuses, neonates, or prisoners are not included in this research study.

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
FDG PET/CT imaging	Radiation	Single arm

Primary outcome

disease-free survival
Time frame: 3 years

Results and safety

The study was stopped early (reason given: low recruitment due to changing treatment landscape for subject population). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.

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.

Michael Farwell, MD principal investigator

Abramson Cancer Center at Penn Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 5 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 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

Are results available for this study?

The study was stopped early (reason given: low recruitment due to changing treatment landscape for subject population). 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?

disease-free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02716077.

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 23 Jul 2021.