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Taking people in NetherlandsPhase 4

Tests a melanoma test to guide choice of immunotherapy treatment

Tests the IOpener-melanoma test to guide immunotherapy in adults with advanced melanoma.

Key facts

Who runs it
Leids Universitair Medisch Centrum (LUMC)
Where
Leiden and Zwolle, NetherlandsSee the 2 sites
Registry title
CO2MO
Status
Recruiting
Phase
Phase 4
People taking part
96 people, planned
Started
14 Jan 2026
Expected to end
1 Jul 2030
Type of study
Interventional
Record updated
25 July 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with melanoma that cannot be removed by surgery (stage III or IV), for whom immunotherapy with checkpoint inhibitors is being considered.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Cutaneous (skin) melanoma, stage III that cannot be removed by surgery, or stage IV. Brain metastases are allowed only if they cause no symptoms or have been treated.
Earlier treatment
No earlier treatment for unresectable stage III or stage IV melanoma with BRAF/MEK inhibitors or immunotherapy. No anti-PD1 immunotherapy before or after surgery within the last 6 months.

Main reasons for not taking part

  • Serum LDH more than 2x ULN
  • Brain metastases that cause symptoms
  • WHO performance score above 2
  • Pregnant, lactating or breast-feeding women
  • Other experimental treatments that may interfere with the immunotherapy

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Netherlands

  • Leids Universitair Medisch Centrum (LUMC)Leiden, NetherlandsTaking people
  • Isala Klinieken StichtingZwolle, NetherlandsTaking people

About the trial

What the trial wants to find out

To evaluate clinical performance of IOpener-melanoma in patients where standard of care treatment selection is based on IOpener-melanoma test result

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
(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.
Plain-language title
Tests a melanoma test to guide choice of immunotherapy treatmentGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
25 July 2025