CO2MO
Key facts
- Where
- Leiden és Zwolle, HollandiaSee the 2 sites
- Phase
- 4. fázis
Where in Hollandia
- Leids Universitair Medisch Centrum (LUMC)Leiden, HollandiaTaking people
- Isala Klinieken StichtingZwolle, HollandiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Leids Universitair Medisch Centrum (LUMC)
- Trial code
- EU 2025-520913-29-00
- Record updated
- 2025. július 25.
- Original description
To evaluate clinical performance of IOpener-melanoma in patients where standard of care treatment selection is based on IOpener-melanoma test resultRead full original descriptionShow less
(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.
To evaluate clinical performance of IOpener-melanoma in patients where standard of care treatment selection is based on IOpener-melanoma test result
Inclusion: 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.
Exclusion: 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; Serum LDH >2x ULN; 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.