Trial Outcomes & Findings for Imaging FDG Flare in Melanoma (NCT NCT02791594)

Last Updated: 2024-11-08

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

21 participants

Primary outcome timeframe

6 months

Results posted on

2024-11-08

Participant Flow

Participant milestones

Participant milestones
Measure	Early FDG PET/CT Imaging Group Patients with advanced melanoma (Stage 3B - Stage 4) scheduled to be treated with pembrolizumab had a baseline 18F-fluorodeoxyglucose (FDG) PET/CT scan (PET0) at a median of 9 days (range, 0 - 24 days) prior to initiation of pembrolizumab, and a follow-up FDG PET/CT scan (PET1) at a median of 7 days (range, 3 - 21 days) after the first dose of pembrolizumab.
Overall Study STARTED	21
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Early FDG PET/CT Imaging Group Patients with advanced melanoma (Stage 3B - Stage 4) scheduled to be treated with pembrolizumab had a baseline 18F-fluorodeoxyglucose (FDG) PET/CT scan (PET0) at a median of 9 days (range, 0 - 24 days) prior to initiation of pembrolizumab, and a follow-up FDG PET/CT scan (PET1) at a median of 7 days (range, 3 - 21 days) after the first dose of pembrolizumab.
Overall Study Physician Decision	2

Baseline Characteristics

Imaging FDG Flare in Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Early FDG PET/CT Imaging Group n=19 Participants Patients with advanced melanoma (Stage 3B - Stage 4) scheduled to be treated with pembrolizumab had a baseline 18F-fluorodeoxyglucose (FDG) PET/CT scan (PET0) at a median of 9 days (range, 0 - 24 days) prior to initiation of pembrolizumab, and a follow-up FDG PET/CT scan (PET1) at a median of 7 days (range, 3 - 21 days) after the first dose of pembrolizumab.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants
Cancer Stage Stage 3B	2 Participants n=5 Participants
Cancer Stage Stage 3C	4 Participants n=5 Participants
Cancer Stage Stage 4	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Early FDG PET/CT Imaging Group n=19 Participants Patients with advanced melanoma (Stage 3B - Stage 4) scheduled to be treated with pembrolizumab had a baseline 18F-fluorodeoxyglucose (FDG) PET/CT scan (PET0) at a median of 9 days (range, 0 - 24 days) prior to initiation of pembrolizumab, and a follow-up FDG PET/CT scan (PET1) at a median of 7 days (range, 3 - 21 days) after the first dose of pembrolizumab.
Objective Response by RECIST Version 1.1 Responders (complete response + partial response)	11 Participants
Objective Response by RECIST Version 1.1 Non-responders (progressive disease or pathologic non-response)	8 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Early FDG PET/CT Imaging Group n=19 Participants Patients with advanced melanoma (Stage 3B - Stage 4) scheduled to be treated with pembrolizumab had a baseline 18F-fluorodeoxyglucose (FDG) PET/CT scan (PET0) at a median of 9 days (range, 0 - 24 days) prior to initiation of pembrolizumab, and a follow-up FDG PET/CT scan (PET1) at a median of 7 days (range, 3 - 21 days) after the first dose of pembrolizumab.
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 Metabolic Flare or Metabolic Response	6 Participants
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 Stable Metabolism	13 Participants

SECONDARY outcome

Timeframe: 4 years

Population: The overall number of participants analyzed is 19, but the progression-free survival was calculated for each cohort: MF-MR cohort (6 participants) and SM cohort (13 participants).

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.

Outcome measures

Outcome measures
Measure	Early FDG PET/CT Imaging Group n=19 Participants Patients with advanced melanoma (Stage 3B - Stage 4) scheduled to be treated with pembrolizumab had a baseline 18F-fluorodeoxyglucose (FDG) PET/CT scan (PET0) at a median of 9 days (range, 0 - 24 days) prior to initiation of pembrolizumab, and a follow-up FDG PET/CT scan (PET1) at a median of 7 days (range, 3 - 21 days) after the first dose of pembrolizumab.
Progression-Free Survival MF-MR cohort	NA months Median PFS was not reached in this cohort (but was \>38 months) because there were an insufficient number of participants with events.
Progression-Free Survival SM cohort	2.8 months Interval 0.3 to 5.2

SECONDARY outcome

Timeframe: 4 years

Population: The overall number of participants analyzed is 19, but the overall survival was calculated for each cohort: MF-MR cohort (6 participants) and SM cohort (13 participants).

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.

Outcome measures

Outcome measures
Measure	Early FDG PET/CT Imaging Group n=19 Participants Patients with advanced melanoma (Stage 3B - Stage 4) scheduled to be treated with pembrolizumab had a baseline 18F-fluorodeoxyglucose (FDG) PET/CT scan (PET0) at a median of 9 days (range, 0 - 24 days) prior to initiation of pembrolizumab, and a follow-up FDG PET/CT scan (PET1) at a median of 7 days (range, 3 - 21 days) after the first dose of pembrolizumab.
Overall Survival MF-MR cohort	17 percentage of patients that died
Overall Survival SM cohort	38 percentage of patients that died

Adverse Events

Early FDG PET/CT Imaging Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 6 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michael Farwell

Abramson Cancer Center

Phone: 215-662-7750

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place