Observational Study of Patients with Advanced Melanoma (skin Cancer) to Assess If IOpener®-melanoma Test Can Predict Response to Immunotherapy. (COMO)

Pamgene International B.V.

Status

Enrolling

Conditions

Melanoma Stage III or IV

Melanoma Metastatic

Melanoma Advanced

Melanoma, Skin

Treatments

Diagnostic Test: PBMC Kinase Activity Profile

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT06784778

IOpener®-melanoma COMO

Details and patient eligibility

About

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.

Enrollment

196 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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.