Observational Study of Patients with Advanced Melanoma (skin Cancer) to Assess If IOpener®-melanoma Test Can Predict Response to Immunotherapy. (COMO)

February 25, 2025 updated by: Pamgene International B.V.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

196

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
    • Baden-Württemberg
      • Tübingen, Baden-Württemberg, Germany, 72016
        • Recruiting
        • Universitatsklinikum Tubingen
        • Contact:
          • Teresa Amaral
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with advanced-stage melanoma who will receive standard-of-care treatment with immune checkpoint inhibitors (ICIs).

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Standard of care anti-PD1 monotherapy
Patients receiving nivolumab or pembrolizumab.
Diagnostic test: PBMC Kinase Activity Profile
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
Other Names:
  • IOpener-melanoma
Standard of care combination therapy
Patients receiving ipilimumab plus nivolumab.
Diagnostic test: PBMC Kinase Activity Profile
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
Other Names:
  • IOpener-melanoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the enrollment to 12 months follow up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Control Rate at 1 year
Time Frame: From enrollment to 12 months follow up.
Disease Control Rate (DCR, "clinical benefit") at 1 year, based on Best Overall Response (BOR) according to RECIST 1.1.
From enrollment to 12 months follow up.
Overall Response Rate (ORR) at 1 year
Time Frame: From enrollment to 12 months follow up.
Overall Response Rate (ORR) at 1 year based on Best Overall Response (BOR) according to RECIST 1.1.
From enrollment to 12 months follow up.
Progression Free Survival
Time Frame: From enrollment to month 24 follow up.
Progression Free Survival
From enrollment to month 24 follow up.
Overall Survival
Time Frame: From enrollment to month 24 follow up.
Overall Survival
From enrollment to month 24 follow up.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: From enrollment to month 24 follow up.
Occurrence and type of adverse event or toxicity associated with standard of care.
From enrollment to month 24 follow up.
Medical costs
Time Frame: From enrollment to month 24 follow up.
Medical costs/medical care consumption associated with adverse events
From enrollment to month 24 follow up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pamgene International B.V.

Collaborators

University Hospital Tuebingen
lron Bridge GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

January 6, 2025

First Submitted That Met QC Criteria

January 15, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 25, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IOpener®-melanoma COMO

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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