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

NCT06784778 | Recruiting

• 1 other identifier: IOpener®-melanoma COMO
• Study Type: observational
• Target: 196
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

melanoma; IOpener; immunotherapy; immune checkpoint inhibitor

Outcome Measures

Primary Outcomes (1)

• 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.

  From the enrollment to 12 months follow up.

Secondary Outcomes (4)

• Disease Control Rate at 1 year

  From enrollment to 12 months follow up.

• Overall Response Rate (ORR) at 1 year

  From enrollment to 12 months follow up.

• Progression Free Survival

  From enrollment to month 24 follow up.

• Overall Survival

  From enrollment to month 24 follow up.

Other Outcomes (2)

• Adverse events

  From enrollment to month 24 follow up.

• Medical costs

  From enrollment to month 24 follow up.

Study Arms (2)

Standard of care anti-PD1 monotherapy

Patients receiving nivolumab or pembrolizumab.

Diagnostic Test: PBMC Kinase Activity Profile

Standard of care combination therapy

Patients receiving ipilimumab plus nivolumab.

Diagnostic Test: PBMC Kinase Activity Profile

Interventions

PBMC Kinase Activity Profile DIAGNOSTIC_TEST

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

Also known as: IOpener-melanoma

Standard of care anti-PD1 monotherapy; Standard of care combination therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pamgene International B.V.: lead
• University Hospital Tuebingen: collaborator
• lron Bridge GmbH: collaborator

Study Sites (3)

Universitätsklinikum Tübingen

Tübingen, Baden-Wurttemberg, 72016, Germany

RECRUITING

Heidelberg University Hospital

Heidelberg, 69120, Germany

RECRUITING

LMU Klinikum

München, 80337, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral Blood Mononuclear Cells (PBMCs) isolated from blood.

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Project Leader Clinical Trials

CONTACT

+ 31 (0) 73 615 80 71; dvdheuvel@pamgene.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 20, 2025
• Study Start: July 12, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 28, 2025

Record last verified: 2025-01

Locations

DE (3)