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Trial Title:
TRAQinform Assessment of Immunotherapy Response
NCT ID:
NCT05819255
Condition:
Melanoma
Conditions: Official terms:
Melanoma
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Non-Interventional
Description:
This prospective, non-interventional clinical study will enroll patients with metastatic
melanoma, who have been selected by their oncologist to receive standard of care
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.
Summary:
The intent of this study is to evaluate the actionable information output from the
TRAQinform Immuno technology in a prospective, non-interventional clinical study.
Subjects with metastatic melanoma treated with standard of care (SOC) dual-agent
immunotherapy will be enrolled. Subjects will receive SOC immunotherapy monitored for
treatment response with FDG PET/CT's at baseline (SOC), after 3-4 weeks of treatment
(non-SOC) and 12 at weeks of treatment (SOC).
Detailed description:
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.
Criteria for eligibility:
Study pop:
Patients with metastatic melanoma.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Diagnosis of metastatic melanoma and is planned to start or has received one cycle
of treatment with standard of care, dual-agent immunotherapy.
- Previous adjuvant anti-PD-I monotherapy is allowed. Patients must be greater than 6
months from the last treatment.
- Previous adjuvant BRAF/MEK therapy is allowed.
- Ability to tolerate 3 FDG PET/CT procedures. One at baseline, prior to the start of
the combination immuno therapy, after 3 - 4 weeks of the combination immunotherapy
treatment, and at 12 weeks of the combination treatment.
- Estimated life expectancy of greater than 12 months at screening.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at
screening.
- Deemed suitable for starting standard of care combination immunotherapy for
metastatic melanoma.
- Willing and able to provide informed consent for FDG PET/CT imaging.
Exclusion Criteria:
- Any concurrent disease, infection, or comorbid condition that interferes with the
ability of the patient to participate in the trial; places the patient at undue
risk; or complicates the interpretation of the data, in the opinion of the
investigator.
- A second malignancy
- Pregnancy or women who are breast feeding
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Aleigha Lawless
Phone:
617-643-3578
Email:
ALAWLESS@PARTNERS.ORG
Facility:
Name:
University of Wisconsin Carbone Cancer Center
Address:
City:
Madison
Zip:
53792
Country:
United States
Status:
Recruiting
Contact:
Last name:
Renae Quale
Phone:
608-265-2789
Email:
rmq@medicine.wisc.edu
Start date:
June 23, 2023
Completion date:
April 30, 2025
Lead sponsor:
Agency:
AIQ Solutions
Agency class:
Industry
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Collaborator:
Agency:
Massachusetts General Hospital
Agency class:
Other
Collaborator:
Agency:
University of Wisconsin, Madison
Agency class:
Other
Source:
AIQ Solutions
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05819255
