Observational Study of Patients With Advanced Melanoma (Skin Cancer) to Assess if IOpener®-Melanoma Test Can Predict Response to Immunotherapy.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PBMC Kinase Activity Profile.
- Who it may be relevant to
- Registry conditions: Melanoma Metastatic, Melanoma, Skin, Melanoma Stage III or IV, Melanoma Advanced. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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.
Overview
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.
Interventions
- Diagnostic test PBMC Kinase Activity Profile
Kinase activity profile will be correlated to the observed clinical outcome parameters (including survival and toxicity associated with the therapy) of standard of care treatments
Primary outcome measures
- 12 months Progression Free Survival rate [Time frame: From the enrollment to 12 months follow up.]
Secondary outcome measures (4)
- Disease Control Rate at 1 year [Time frame: From enrollment to 12 months follow up.]
- Overall Response Rate (ORR) at 1 year [Time frame: From enrollment to 12 months follow up.]
- Progression Free Survival [Time frame: From enrollment to month 24 follow up.]
- Overall Survival [Time frame: From enrollment to month 24 follow up.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 3 centers
- Universitätsklinikum Tübingen — Tübingen
- Heidelberg University Hospital — Heidelberg
- LMU Klinikum — München
Identifiers
NCT: NCT06784778 · IOpener®-melanoma COMO