Clinical trial · Observational
Observational Study of Patients With Advanced Melanoma (Skin Cancer) to Assess if IOpener®-Melanoma Test Can Predict Response to Immunotherapy.
A Prospective, Observational, Multicenter Clinical Performance Study to Evaluate IOpener®-Melanoma Test for Predicting Response to Combination or Mono Immunotherapy in Stage III or IV Cutaneous Melanoma Patients.
- 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 goal of this observational study is to assess whether the IOpener® melanoma test can assist treating physicians in deciding which therapy is most suitable for patients with skin cancer (advanced cutaneous melanoma). For this purpose it is evaluated how well the IOpener-melanoma test can predict the result of cancer treatment in the treatment groups (standard of care anti-PD1 mono-therapy and standard of care anti-PD1 + anti-CTLA-4 therapy). Participants will be asked to provide blood sample for analysis using IOpener®-melanoma test. Patients will receive regular medical care, the test results will not be used to make any treatment decisions. The patients will visit the clinic for treatment administration and clinical evaluation as part of their regular medical care.
Conditions
Conditions (4)
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 Advanced | — | UNRESOLVED | — |
| Melanoma Metastatic | — | UNRESOLVED | — |
| Melanoma, Skin | Cutaneous Melanoma | ALIAS | 0.90 |
| Melanoma Stage III or IV | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PBMC Kinase Activity Profile | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Standard of care anti-PD1 monotherapy
- description
- Patients receiving nivolumab or pembrolizumab.
- interventionNames
- Diagnostic Test: PBMC Kinase Activity Profile
- label
- Standard of care combination therapy
- description
- Patients receiving ipilimumab plus nivolumab.
- interventionNames
- Diagnostic Test: PBMC Kinase Activity Profile
Primary outcomes (1)
- measure
- 12 months Progression Free Survival rate
- timeFrame
- From the enrollment to 12 months follow up.
- description
- Predictive value of IOpener-melanoma for 1-year Progression Free Survival (PFS), i.e., proportion of patients without progressive disease (PD) ≥ 1 year, stratified according to treatment group and IOpener-melanoma test result.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * First line treatment for unresectable stage III or IV cutaneous melanoma (according to AJCC version 8) with anti-PD1 monotherapy (nivolumab or pembrolizumab) or anti-PD1 + anti-CTL4A combination therapy (nivolumab and ipilimumab). * Anticipated life expectancy exceeding 3 months. * Aged 18 years or older and able to provide written informed consent. Patients who have completed adjuvant treatment with anti-PD1 immunotherapy at least 6 months ago can be included. Exclusion Criteria: * Prior treatment for irresectable stage III or stage IV melanoma with BRAF/MEK inhibitors. * Presence of progressive/symptomatic brain metastases at baseline. * WHO performance score ≥ 2. * Adjuvant treatment with anti-PD1 immunotherapy received within the last 6 months. * Patients undergoing experimental treatments or therapies. * Presence of any medical or other condition that in the opinion of the investigator(s) would preclude the participation in a clinical study. * Unwillingness or inability to comply with study and follow-up procedures.
References
Publications (0)
Data not yet available