NCT06784778 Observational Study of Patients With Advanced Melanoma (Skin Cancer) to Assess if IOpener®-Melanoma Test Can Predict Response to Immunotherapy.
| NCT ID | NCT06784778 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pamgene International B.V. |
| Condition | Melanoma Metastatic |
| Study Type | OBSERVATIONAL |
| Enrollment | 196 participants |
| Start Date | 2024-07-12 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 196 participants in total. It began in 2024-07-12 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06784778 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Melanoma Metastatic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06784778 currently recruiting?
Yes, NCT06784778 is actively recruiting participants. Contact the research team at dvdheuvel@pamgene.com for enrollment information.
Where is the NCT06784778 trial being conducted?
This trial is being conducted at Tübingen, Germany, Heidelberg, Germany, München, Germany.
Who is sponsoring the NCT06784778 clinical trial?
NCT06784778 is sponsored by Pamgene International B.V.. The trial plans to enroll 196 participants.
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