Biomarkers for the Activity of Immune Checkpoint Inhibitor Therapy in Patients With Advanced Melanoma

Study Overview
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Brief Summary
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Screen and recruitment: patients will be screened based on their prior history and intention to initiate treatment with an immune checkpoint inhibitor. Study phase: Collection of baseline demographic data, prior disease history, nature of ICI therapy, outcome data of ICI therapy (treatment disposition, toxicity, tumor response and survival). Collection of blood samples will be performed every 3 to 4 weeks for the first year on ICI therapy and every 6 to 12 weeks thereafter until the end of ICI therapy, disease progression, death or loss to follow-up. Collection of blood samples will be aligned with the visits necessary for the administration of the ICI therapy. Collection of archival melanoma metastasis tissues will be performed on a continuous basis and be triggered by availability of such tissue following therapeutic resections of melanoma metastases. Follow-up phase

Detailed Description
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Screen and recruitment: patients will be screened based on their prior history and intention to initiate treatment with an immune checkpoint inhibitor. This screening of candidate patients by the investigators will be non-interventional. Patients that are considered eligible candidates will be invited to participate in this study and to Page 3/18 provide written informed consent. Study phase: Collection of baseline demographic data, prior disease history, nature of ICI therapy, outcome data of ICI therapy (treatment disposition, toxicity, tumor response and survival). Collection of blood samples will be performed every 3 to 4 weeks for the first year on ICI therapy and every 6 to 12 weeks thereafter until the end of ICI therapy, disease progression, death or loss to follow-up. Collection of blood samples will be aligned with the visits necessary for the administration of the ICI therapy. Collection of archival melanoma metastasis tissues will be performed on a continuous basis and be triggered by availability of such tissue following therapeutic resections of melanoma metastases. Follow-up phase: patients who stop treatment with the immune checkpoint inhibitor will be followed-up for

Official Title
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Biomarkers for the Activity of Immune Checkpoint Inhibitor Therapy in Patients With Advanced Melanoma

Conditions
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Malignant Melanoma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed malignant melanoma; AJCC Stage IIIC or IV melanoma with evaluable disease; Treatment with an immune checkpoint inhibitor; Willing and able to give written informed consent; Accessible for treatment and follow-up; Exclusion Criteria: non

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| observational arm<br>From start treatment till date of death or date of cure, the patient will be followed for survival and adverse events on pembrolizumab | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| explore the value of biomarkers present in blood, and tumor tissue for the purpose of predicting the efficacy of ICI therapy or for the purpose of monitoring the therapeutic effect of ICI therapy | explore the value of biomarkers present in blood, and tumor tissue for the purpose of predicting the efficacy of ICI therapy or for the purpose of monitoring the therapeutic effect of ICI therapy | 1year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline demographic data, prior disease history, nature of ICI therapy, treatment disposition, adverse events | Baseline demographic data, prior disease history, nature of ICI therapy, treatment disposition, adverse events | 1year | 
| Tumor response according to the RECISTv1.1 and irRC criteria | Tumor response according to the RECISTv1.1 and irRC criteria | 1 year | 
| Survival (PFS, and OS) by Kaplan-Meier estimates | Survival (PFS, and OS) by Kaplan-Meier estimates | 1year | 
| Data collection on the nature and disposition of ICI therapy as well as its efficacy and treatment related adverse events will be collected on a non-interventional basis | Data collection on the nature and disposition of ICI therapy as well as its efficacy and treatment related adverse events will be collected on a non-interventional basis | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Melanoma