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Observational Study of Patients With Advanced Melanoma (Skin Cancer) to Assess if IOpener®-Melanoma Test Can Predict Response to Immunotherapy.

NCT06784778 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 196

Last updated 2025-02-28

No results posted yet for this study

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). 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.

Conditions

  • Melanoma Metastatic
  • Melanoma, Skin
  • Melanoma Stage III or IV
  • Melanoma Advanced

Interventions

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

Sponsors & Collaborators

  • University Hospital Tuebingen

    collaborator OTHER

  • lron Bridge GmbH

    collaborator UNKNOWN

  • Pamgene International B.V.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-12
Primary Completion
2026-07-31
Completion
2027-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06784778 on ClinicalTrials.gov