Evaluating Immunotherapy Response in Metastatic Melanoma
Comprehensive Assessment of Cancer Immunotherapy Response; Investigating the Intent to Change Treatment Decisions Based Upon TRAQinform Immuno Technology
This study is testing if a new technology can help doctors make better treatment decisions for patients with advanced melanoma who are receiving standard immunotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AIQ Solutions Industry-sponsored |
| Drugs / interventions | immunotherapy |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT05819255 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness of the TRAQinform Immuno technology in providing actionable insights for patients with metastatic melanoma undergoing standard dual-agent immunotherapy. Participants will receive routine FDG PET/CT scans at baseline, after 3-4 weeks, and at 12 weeks of treatment to monitor their response. The study will analyze how the information from TRAQinform Immuno influences treatment decisions made by oncologists. Data will be collected through questionnaires to evaluate the clinical impact of integrating this technology into standard care.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with metastatic melanoma who are starting or have received one cycle of standard dual-agent immunotherapy.
Not a fit: Patients with concurrent diseases or conditions that interfere with treatment or imaging may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance treatment decision-making for patients with metastatic melanoma, potentially leading to improved outcomes.
How similar studies have performed: While the use of imaging technology in treatment response evaluation is established, the specific application of TRAQinform Immuno in this context is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts and 1 other locations
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- University of Wisconsin Carbone Cancer Center — Madison, Wisconsin, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.