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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.

NCT06784778•Pamgene International B.V.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (3)

Universitätsklinikum Tübingen

Tübingen, Baden-Wurttemberg, Germany

Heidelberg University Hospital

Heidelberg, Germany

LMU Klinikum

München, Germany

Key Dates

Start Date

July 12, 2024

Primary Completion Date

July 1, 2026

Completion Date

July 1, 2027

Last Updated

February 28, 2025

Enrollment

196

ESTIMATED participants

Conditions

Melanoma MetastaticMelanoma, SkinMelanoma Stage III or IVMelanoma Advanced

Interventions

PBMC Kinase Activity Profile

DIAGNOSTIC_TEST

Contacts

Project Leader Clinical Trials

CONTACT

+ 31 (0) 73 615 80 71 dvdheuvel@pamgene.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Phase II Clinical Study of Multimodal Ablation Combined With Systemic Drug Therapy for Advanced Solid Tumors.

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