NCT06784778

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.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 196 (estimated)
• Sponsor: Pamgene International B.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Melanoma Metastatic
• Melanoma, Skin
• Melanoma Stage III or IV
• Melanoma Advanced

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	PBMC Kinase Activity Profile	Kinase activity profile will be correlated to the observed clinical outcome parameters (including survival and toxicity associated with the therapy) of standard of care treatments

Timeline

• Start date: 2024-07-12
• Primary completion: 2026-07-01
• Completion: 2027-07-01
• First posted: 2025-01-20
• Last updated: 2025-02-28

Locations

3 sites across 1 country: Germany