Metastatic MelanomaNCT02791594

Imaging FDG Flare in Melanoma

An observational study of Metastatic Melanoma, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Metastatic Melanoma
What is being tested?: Pembrolizumab
How many people: 21 participants
Where: 1 siteUnited States
Study dates: Jun 2016to 1 Jul 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Study population: Melanoma

Who may be able to join

The subject 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.
The subject must be ≥ 18 years of age on day of signing informed consent.
The subject must have biopsy proven or clinically documented advanced stage metastatic melanoma.
The subject must have measurable disease (per RECIST 1.1) that is seen on CT, MRI, or FDG PET/CT.
The subject must be recommended to start pembrolizumab.

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 pregnancy test at the time of the screening visit.
Subject is not able to tolerate imaging procedures in the opinion of the investigator or treating physician.
Subject has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Subject has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent as assessed by medical record review and/or self-reported.
Subject has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies) as determined by medical record review.
Subject has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.

Show all 9Show fewer

Subject has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected) as determined by medical record review.
Subject has known active central nervous system metastases and/or carcinomatous meningitis.
Note: Subjects with previously treated brain metastases will be eligible to participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to receiving pembrolizumab and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment.

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: Imaging the Flare Response With FDG PET/CT in Patients With Advanced Metastatic Melanoma on Pembrolizumab.

Up to 35 adult patients with metastatic melanoma planning to start pembrolizumab will be enrolled in this study with a target enrollment of 30 evaluable subjects. Subjects will complete a baseline FDG PET/CT and an on-treatment FDG PET/CT after 1 week of pembrolizumab therapy. Subjects may also be a part of the Penn Melanoma Tissue Collection Program and then will be asked to have one additional tumor biopsy and one additional blood draw for the purposes of this imaging study. Changes in tumor FDG uptake between the baseline and early on-treatment FDG PET/CT scans will be correlated with blood and tissue results from the patient's medical records and from the data collected as part of the Penn Melanoma Tissue Collection Program and with outcomes including objective response, progression free survival, and overall survival.

Conditions: Metastatic Melanoma
Being tested: Pembrolizumab
Medical subject headings: Melanoma

What participants receive

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

PembrolizumabDrug
Patients were treated with pembrolizumab according to standard of care.

What is being measured

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

Objective Response by RECIST Version 1.1
Objective response is defined as the proportion of patients with a complete response or partial response by RECIST version 1.1. A complete response is defined as the disappearance of all tumor lesions, and a decrease in size of all pathological lymph nodes to <10 mm along the short axis. A partial response is at least a 30% decrease in the sum of diameters of target tumor lesions, taking as reference the baseline sum diameters.
Measured: 6 months
Number of Participants With Change in Tumor FDG Uptake Between Baseline FDG PET/CT and Early On-Treatment FDG PET/CT Obtained 1 Week After Initiation of Pembrolizumab
FDG PET scans were evaluated for changes in maximum standardized uptake value (SUVmax) for up to 5 RECIST-measurable lesions (2 per organ) for each patient. The percentage change in SUVmax was defined as (sum of PET1 SUVmax - sum of PET0 SUVmax)/(sum of PET0 SUVmax) x 100, where PET0 was the baseline FDG PET/CT and PET1 was the on-treatment FDG PET/CT acquired at ~1 week after starting pembrolizumab. A metabolic flare (MF) was defined as >70% increase in tumor SUVmax between baseline and follow-up scans, and a metabolic response (MR) was defined as a >30% decrease in tumor SUVmax. If the change in tumor SUVmax was neither MF or MR it was classified as stable metabolism (SM).
Measured: Baseline and 1 week after initiation of pembrolizumab

Secondary outcomes (2)

Progression-Free Survival
Progression-Free Survival is defined as time from the PET1 scan (acquired 1 week after starting pembrolizumab) to progression, according to RECIST 1.1, or death from any cause, whichever occurs first. Patients who neither progress nor die during the study will be censored at the date of last disease assessment without progression.
Measured: 4 years
Overall Survival
Overall Survival (OS) was defined as time from the PET1 scan (6-10 days after start of immunotherapy) to death from any cause, with patient censoring at date last known alive.
Measured: 4 years

Timeline

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

Jun 20161 Jul 2020

First posted7 Jun 2016 (estimated)
Study startJun 2016
Primary completion1 Jul 2020
Study completion1 Jul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Metastatic 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02791594
Sponsor's protocol ID: UPCC 02616
Status last verified: Nov 2024
First submitted: 1 Jun 2016
Last updated: 8 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis
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SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma
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Active, not recruitingPhase 2
Infliximab for Treatment of Immune Checkpoint Inhibitor Colitis
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RecruitingPhase 1/2
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All Metastatic Melanoma trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Imaging the Flare Response With FDG PET/CT in Patients With Advanced Metastatic Melanoma on Pembrolizumab.
ClinicalTrials.gov ID: NCT02791594
Acronym / sponsor ID: UPCC 02616
Conditions: Metastatic Melanoma
Study type: Observational
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Abramson Cancer Center at Penn MedicineUniversity, hospital or other
Collaborators: Merck Sharp & Dohme LLC
Study start: Jun 2016
Primary completion: 1 Jul 2020 (actual)
Study completion: 1 Jul 2020 (actual)
First posted: 7 Jun 2016 (estimated)
Results: Posted 8 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

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

Key inclusion criteria (5 listed)

The subject 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.
The subject must be ≥ 18 years of age on day of signing informed consent.
The subject must have biopsy proven or clinically documented advanced stage metastatic melanoma.
The subject must have measurable disease (per RECIST 1.1) that is seen on CT, MRI, or FDG PET/CT.
The subject must be recommended to start pembrolizumab.

Key exclusion criteria (9 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 pregnancy test at the time of the screening visit.
Subject is not able to tolerate imaging procedures in the opinion of the investigator or treating physician.
Subject has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Subject has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent as assessed by medical record review and/or self-reported.
Subject has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies) as determined by medical record review.

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
PembrolizumabPatients were treated with pembrolizumab according to standard of care.	Drug	–

Primary outcome

Objective Response by RECIST Version 1.1
Time frame: 6 months
Objective response is defined as the proportion of patients with a complete response or partial response by RECIST version 1.1. A complete response is defined as the disappearance of all tumor lesions, and a decrease in size of all pathological lymph nodes to <10 mm along the short axis. A partial response is at least a 30% decrease in the sum of diameters of target tumor lesions, taking as reference the baseline sum diameters.
Number of Participants With Change in Tumor FDG Uptake Between Baseline FDG PET/CT and Early On-Treatment FDG PET/CT Obtained 1 Week After Initiation of Pembrolizumab
Time frame: Baseline and 1 week after initiation of pembrolizumab
FDG PET scans were evaluated for changes in maximum standardized uptake value (SUVmax) for up to 5 RECIST-measurable lesions (2 per organ) for each patient. The percentage change in SUVmax was defined as (sum of PET1 SUVmax - sum of PET0 SUVmax)/(sum of PET0 SUVmax) x 100, where PET0 was the baseline FDG PET/CT and PET1 was the on-treatment FDG PET/CT acquired at ~1 week after starting pembrolizumab. A metabolic flare (MF) was defined as >70% increase in tumor SUVmax between baseline and follow-up scans, and a metabolic response (MR) was defined as a >30% decrease in tumor SUVmax. If the change in tumor SUVmax was neither MF or MR it was classified as stable metabolism (SM).

2 secondary outcomes

Progression-Free Survival
Time frame: 4 years
Overall Survival
Time frame: 4 years

Results and safety

Results posted to the registry on 8 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Early FDG PET/CT Imaging Group	21	19

Primary outcome: Objective Response by RECIST Version 1.1

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Early FDG PET/CT Imaging Group n = 19
Responders (complete response + partial response)	11
Non-responders (progressive disease or pathologic non-response)	8

Primary outcome: Number of Participants With Change in Tumor FDG Uptake Between Baseline FDG PET/CT and Early On-Treatment FDG PET/CT Obtained 1 Week After Initiation of Pembrolizumab

Time frame: Baseline and 1 week after initiation of pembrolizumab. Count of participants. Unit: Participants

Measure	Early FDG PET/CT Imaging Group n = 19
Metabolic Flare or Metabolic Response	6
Stable Metabolism	13

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-Cause Mortality was monitored/assessed for up to 4 years. Adverse events were monitored/assessed for the period of time from the injection of FDG to the completion of the imaging exam (for 2 hours).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Early FDG PET/CT Imaging Group	0 of 19 (0%)	0 of 19 (0%)	6 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Metastatic Melanoma

Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1/2
Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis
Metastatic Melanoma, Liver Metastases
RecruitingPhase 3
SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma
Melanoma, Cutaneous Malignant, Mucosal Melanoma
Active, not recruitingPhase 2
Infliximab for Treatment of Immune Checkpoint Inhibitor Colitis
Melanoma Stage III, Melanoma Stage IV
RecruitingPhase 1/2
A Study of BL-M08D in Patients With Locally Advanced or Metastatic Melanoma and Other Solid Tumors
Melanoma, Solid Tumors

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?

An observational study of Metastatic Melanoma, run by Abramson Cancer Center at Penn Medicine at 1 site 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 9 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: finished, as of the sponsor's last update on 8 Nov 2024. 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?

Yes. Results are posted in the registry (first posted 8 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Objective Response by RECIST Version 1.1 (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT02791594.

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 Nov 2024.