Blood test study for patients with advanced skin melanoma
Tests whether a blood test can predict response to immunotherapy in advanced melanoma.
Plain-language title generated from the registry record
Registry title: Observational Study of Patients With Advanced Melanoma (Skin Cancer) to Assess if IOpener®-Melanoma Test Can Predict Response to Immunotherapy.
Key facts
- Where
- Heidelberg, München, and Tübingen, GermanySee the 3 sites
Where in Germany
- Heidelberg University HospitalHeidelberg, GermanyTaking people
- LMU KlinikumMünchen, GermanyTaking people
- Universitätsklinikum TübingenTübingen, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Pamgene International B.V.
- Trial code
- NCT06784778
- Record updated
- 28 February 2025
- Original description
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).Read full original descriptionShow less
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.
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.
Inclusion: 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: Prior treatment for irresectable stage III or stage IV melanoma with BRAF/MEK inhibitors; 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; Presence of progressive/symptomatic brain metastases at baseline; WHO performance score ≥ 2; Unwillingness or inability to comply with study and follow-up procedures.