TRAQinform Assessment of Immunotherapy Response

This prospective, non-interventional clinical study will enroll patients with metastatic

melanoma, who have been selected by their oncologist to receive standard of care (SOC)

dual-agent immunotherapy and monitored for treatment response using SOC FDG PET/CTs.

The primary objective of this clinical study is to investigate intent to change treatment

decisions after the addition of treatment response information from the TRAQinform Immuno

technology. For each subject, FDG PET/CT #1, #2 and #3 will be transmitted to AIQ

Solutions (Madison, WI) for treatment response analysis using TRAQinform Immuno, a

software technology that identifies, matches and quantifies metastatic cancer regions of

interest. A TRAQinform Immuno report will be returned to the oncology/nuclear medicine

paired investigator teams, after the first clinical decision point following FDG PET/CT

#1 and #2 and again after the second clinical decision point following FDG PET/CT #3. The

investigator team at each site will complete an "intent to change" questionnaire for each

subject at Data Collection Point #1 and at Data Collection Point #2. The clinical study

will evaluate the Data Collection Point questionnaires to help understand the clinical

impact of the addition of TRAQinform Immuno analysis into the clinical workflow.

To address the status quo bias of the investigator teams, the TRAQinform Immuno reports

for subjects enrolled at each site, including the additional limited data that is

necessary to make a treatment decision, will be shared between teams. The first

investigator team, without knowledge of the treatment decision made by the second

investigator team, will independently answer the Data Collection Point #3 questionnaire

and vice versa.

An exploratory objective of this clinical trial is to investigate if treatment

effectiveness and adverse events could be detected on FDG PET/CT images at 3-4 weeks of

the combination immunotherapy.