(CO2MO) A prospective, 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

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-520913-29-00

Acronym

CO2MO

Enrollment

Registered

2025-07-25

Start date

2026-01-14

Completion date

Unknown

Last updated

2025-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

Brief summary

• 1-Year PFS (proportion of patients with Progression Free Survival ^ 1 year)

Detailed description

Disease Control Rate (DCR, "clinical benefit”), based on Best Overall Response according to RECIST 1.1, overal response Rate (ORR) based on Best Overall Response according tot RECIST 1.1, overall survival (OS) and progression free survial (PFS), Quality of Life (QoL) using EQ-5D-5L, Medical Costs

Interventions

DRUGPEMBROLIZUMAB

DRUGNIVOLUMAB

DRUGIPILIMUMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
• 1-Year PFS (proportion of patients with Progression Free Survival ^ 1 year)	—

Secondary

Measure	Time frame
Disease Control Rate (DCR, "clinical benefit”), based on Best Overall Response according to RECIST 1.1, overal response Rate (ORR) based on Best Overall Response according tot RECIST 1.1, overall survival (OS) and progression free survial (PFS), Quality of Life (QoL) using EQ-5D-5L, Medical Costs	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026