Observational Study of Patients With Advanced Melanoma (Skin Cancer) to Assess if IOpener®-Melanoma Test Can Predict Response to Immunotherapy.

Launched by PAMGENE INTERNATIONAL B.V. · Jan 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the IOpener® melanoma test, which is designed to help doctors understand how well certain treatments might work for patients with advanced skin cancer known as melanoma. Specifically, the trial aims to see if this test can predict how patients will respond to two types of standard immunotherapy treatments: one that uses a single drug (anti-PD1) and another that uses a combination of two drugs (anti-PD1 and anti-CTLA-4).

To be eligible for the study, participants need to be at least 18 years old and have been diagnosed with advanced melanoma that cannot be surgically removed. They should also be starting their first round of treatment with one of the specified therapies and expect to live for at least three more months. If you decide to participate, you will provide a blood sample for the IOpener® test, but it won’t affect your treatment decisions. Throughout the trial, you will continue to receive your regular medical care and attend clinic visits for treatment and check-ups. The study is currently looking for participants, so if you or someone you know meets the criteria, it might be a good opportunity to consider.

Gender

ALL

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.