Melanoma MetastaticCOMONCT06784778
Observational Study of Patients With Advanced Melanoma (Skin Cancer) to Assess if IOpener®-Melanoma Test Can Predict Response to Immunotherapy.
An observational study of Melanoma Metastatic and Melanoma, Skin, run by Pamgene International B.V. at 3 sites in Germany.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma Metastatic, Melanoma, Skin, Melanoma Stage III or IV
- What is being tested?
- PBMC Kinase Activity Profile
- How many people
- 196 participants
- Where
- 3 sitesGermany
- Study dates
- 12 Jul 2024to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with advanced-stage melanoma who will receive standard-of-care treatment with immune checkpoint inhibitors (ICIs).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany3 sites, 3 recruiting
- Recruiting
Heidelberg University Hospital
Heidelberg, 69120
Jessica Hassel, Prof. Dr. med., +49 6221 56 8562, nct.dermaonko@med.uni-heidelberg.de
- Recruiting
LMU Klinikum
München, 80337
Lucie Heinzerling, Prof. Dr. med., MPH, +4989440056326, DER.onko.studien@med.uni-muenchen.de
- Recruiting
Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, 72016
Teresa Amaral, MD, PhD, +49 7071 29 84555, teresa.amaral@med.uni-tuebingen.de
Teresa Amaral
About this study
Official title: A Prospective, Observational, 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.
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.
- Being tested
- PBMC Kinase Activity Profile
- Keywords
- melanoma, IOpener, immunotherapy, immune checkpoint inhibitor
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBMC Kinase Activity ProfileDiagnostic test
Also called IOpener-melanoma
Kinase activity profile will be correlated to the observed clinical outcome parameters (including survival and toxicity associated with the therapy) of standard of care treatments
| Study group | Role | What they receive |
|---|---|---|
| Standard of care anti-PD1 monotherapy | Patients receiving nivolumab or pembrolizumab. Receives: Diagnostic Test: PBMC Kinase Activity Profile | |
| Standard of care combination therapy | Patients receiving ipilimumab plus nivolumab. Receives: Diagnostic Test: PBMC Kinase Activity Profile |
What is being measured
The primary outcome is the main question the study is designed to answer.
12 months Progression Free Survival rate
Predictive value of IOpener-melanoma for 1-year Progression Free Survival (PFS), i.e., proportion of patients without progressive disease (PD) ≥ 1 year, stratified according to treatment group and IOpener-melanoma test result.
Measured: From the enrollment to 12 months follow up.
Secondary outcomes (4)
Disease Control Rate at 1 year
Disease Control Rate (DCR, "clinical benefit") at 1 year, based on Best Overall Response (BOR) according to RECIST 1.1.
Measured: From enrollment to 12 months follow up.
Overall Response Rate (ORR) at 1 year
Overall Response Rate (ORR) at 1 year based on Best Overall Response (BOR) according to RECIST 1.1.
Measured: From enrollment to 12 months follow up.
Progression Free Survival
Progression Free Survival
Measured: From enrollment to month 24 follow up.
Overall Survival
Overall Survival
Measured: From enrollment to month 24 follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start12 Jul 2024
- Primary completionJul 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamgene International B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital Tuebingen, lron Bridge GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06784778
- Sponsor's protocol ID
- IOpener®-melanoma COMO
- Acronym
- COMO
- Status last verified
- Jan 2025
- First submitted
- 6 Jan 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational, 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.
- ClinicalTrials.gov ID
- NCT06784778
- Acronym / sponsor ID
- COMO / IOpener®-melanoma COMO
- Keywords
- melanoma, IOpener, immunotherapy, immune checkpoint inhibitor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Pamgene International B.V.Industry (pharma, biotech, devices)
- Collaborators
- University Hospital Tuebingen, lron Bridge GmbH
- Study start
- 12 Jul 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care anti-PD1 monotherapy | – | Diagnostic Test: PBMC Kinase Activity ProfilePatients receiving nivolumab or pembrolizumab. |
| Standard of care combination therapy | – | Diagnostic Test: PBMC Kinase Activity ProfilePatients receiving ipilimumab plus nivolumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced-stage melanoma who will receive standard-of-care treatment with immune checkpoint inhibitors (ICIs).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PBMC Kinase Activity ProfileAlso: IOpener-melanomaKinase activity profile will be correlated to the observed clinical outcome parameters (including survival and toxicity associated with the therapy) of standard of care treatments | Diagnostic test | Standard of care anti-PD1 monotherapy, Standard of care combination therapy |
Primary outcome
12 months Progression Free Survival rate
Time frame: From the enrollment to 12 months follow up.
Predictive value of IOpener-melanoma for 1-year Progression Free Survival (PFS), i.e., proportion of patients without progressive disease (PD) ≥ 1 year, stratified according to treatment group and IOpener-melanoma test result.
4 secondary outcomes
Disease Control Rate at 1 year
Time frame: From enrollment to 12 months follow up.
Overall Response Rate (ORR) at 1 year
Time frame: From enrollment to 12 months follow up.
Progression Free Survival
Time frame: From enrollment to month 24 follow up.
Overall Survival
Time frame: From enrollment to month 24 follow up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma Metastatic and Melanoma, Skin, run by Pamgene International B.V. at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Project Leader Clinical Trials (+ 31 (0) 73 615 80 71, dvdheuvel@pamgene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12 months Progression Free Survival rate (time frame: From the enrollment to 12 months follow up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.