Clinical trial NCT06784778: Observational Study of Patients With Advanced Melanoma (Skin Cancer) to Assess if IOpener®-Melanoma Test Can Predict Response to Immunotherapy.
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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Melanoma Metastatic
Melanoma, Skin
Melanoma Stage III or IV
Melanoma Advanced
Keywords: melanoma
IOpener
immunotherapy
immune checkpoint inhibitor
Lead sponsor: Pamgene International B.V.
Sponsor class: INDUSTRY
Collaborators: name: University Hospital Tuebingen
name: lron Bridge GmbH
First posted: 2025-01-20
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced-stage melanoma who will receive standard-of-care treatment with immune checkpoint inhibitors (ICIs).

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 12 months Progression Free Survival rate
timeFrame: From the enrollment to 12 months follow up.
Secondary outcomes:
measure: Disease Control Rate at 1 year
timeFrame: From enrollment to 12 months follow up.
measure: Overall Response Rate (ORR) at 1 year
timeFrame: From enrollment to 12 months follow up.
measure: Progression Free Survival
timeFrame: From enrollment to month 24 follow up.
measure: Overall Survival
timeFrame: From enrollment to month 24 follow up.
Other outcomes:
measure: Adverse events
timeFrame: From enrollment to month 24 follow up.
measure: Medical costs
timeFrame: From enrollment to month 24 follow up.
Locations:
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
state: Baden-Württemberg
city: Heidelberg
country: Germany
facility: Heidelberg University Hospital
city: München
country: Germany
facility: LMU Klinikum
Study officials:
References: