Clinical trial · Observational
TRAQinform Assessment of Immunotherapy Response
Comprehensive Assessment of Cancer Immunotherapy Response; Investigating the Intent to Change Treatment Decisions Based Upon TRAQinform Immuno Technology
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-Interventional | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To Investigate Intent to Change Treatment Decisions.
- timeFrame
- 12 weeks
- description
- Treatment response will be analyzed using TRAQinform Immuno Technology which is a software technology that identifies, matches, and quantifies metastatic cancer regions of interest. The clinical study will evaluate investigator questionaries to help understand the clinical impact of the addition of the TRAQinform Immuno analysis into the clinical work flow.
Secondary outcomes (1)
- measure
- Adverse Events and Treatment Efficacy Prediction
- timeFrame
- 4 weeks
- description
- To investigate if treatment effectiveness and adverse events can be detected on week 3-4 FDG PET/CT. An additional FDG PET/CT will be obtained on all subjects between weeks three and four to evaluate if TRAQinform Immuno can predict adverse events and treatment effectiveness.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available