NCT06784778Recruiting
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 · Last updated 28 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 196 (estimated)
- First submitted
- 6 Jan 2025
- Start date
- 12 Jul 2024
- Primary completion date
- Jul 2026
- Lead sponsor
- Pamgene International B.V.
- Diseases
- Melanoma
- NCT number
- NCT06784778
What you commit to
- Study type: Observational
- Planned participants: 196
- From 12 Jul 2024 to the primary completion date, Jul 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Presence of any medical or other condition that in the opinion of the investigator(s) would preclude the participation in a clinical study.
Other
- Presence of progressive/symptomatic brain metastases at baseline.
- WHO performance score ≥ 2.
- Unwillingness or inability to comply with study and follow-up procedures.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Heidelberg University Hospital Coordinator of this site? Confirm its status | Heidelberg | Germany | Recruiting |
| LMU Klinikum Coordinator of this site? Confirm its status | München | Germany | Recruiting |
| Universitätsklinikum Tübingen Coordinator of this site? Confirm its status | Tübingen | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.