2025-520913-29-00RecruitingPhase 4
CO2MO
(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.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 25 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To evaluate clinical performance of IOpener-melanoma in patients where standard of care treatment selection is based on IOpener-melanoma test result
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 96 (estimated)
- First submitted
- 16 May 2025
- Start date
- 14 Jan 2026
- Lead sponsor
- Leids Universitair Medisch Centrum (LUMC)
- Diseases
- Melanoma
- EU CT number
- 2025-520913-29-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 96
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment for irresectable stage III or stage IV melanoma with BRAF/MEK inhibitors or immunotherapy
- (Neo)adjuvant treatment with anti-PD1 immunotherapy received within the last 6 months.
- Patients undergoing other experimental treatments or therapies that may interfere with the immunotherapy's mechanism of action or assessment of its effects might be excluded.
Lab values
- Serum LDH >2x ULN.
Other
- Presence of symptomatic brain metastases
- WHO performance score > 2.
- Pregnant, lactating, or breast-feeding women.
- Presence of any medical or other conditiën 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
Who the study is looking for
- Unresectable stage III or stage IV cutaneous melanoma for whom treatment with immune checkpoint inhibitors (ICIs) is considered by the treating physician.
- Inclusion of patients with brain metastases is permitted if the metastases are asymptomatic or have been treated.
- Anticipated life expectancy exceeding 3 months.
- Aged 18 years or older and written informed consent for participation in the study.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Leids Universitair Medisch Centrum (LUMC) | Leiden | Netherlands | Recruiting |
| Isala Klinieken Stichting | Zwolle | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.