Melanoma Advanced, Melanoma Metastatic, Melanoma, Skin, Melanoma Stage III or IV
Conditions
Keywords
melanoma, IOpener, immunotherapy, immune checkpoint inhibitor
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.
Interventions
DIAGNOSTIC_TESTPBMC 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
University Hospital Tuebingen
lron Bridge GmbH
Pamgene International B.V.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 12 months Progression Free Survival rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Control Rate at 1 year | 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. |
| Overall Response Rate (ORR) at 1 year | 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. |
| Progression Free Survival | From enrollment to month 24 follow up. | Progression Free Survival |
| Overall Survival | From enrollment to month 24 follow up. | Overall Survival |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | From enrollment to month 24 follow up. | Occurrence and type of adverse event or toxicity associated with standard of care. |
| Medical costs | From enrollment to month 24 follow up. | Medical costs/medical care consumption associated with adverse events |
Countries
Germany
Contacts
Primary ContactProject Leader Clinical Trials
Outcome results
None listed