Malignant Melanoma
Conditions
Keywords
Melanoma
Brief summary
1. Screen and recruitment: patients will be screened based on their prior history and intention to initiate treatment with an immune checkpoint inhibitor. 2. 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. 3. Follow-up phase
Detailed description
1. 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. 2. 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. 3. Follow-up phase: patients who stop treatment with the immune checkpoint inhibitor will be followed-up for
Interventions
None listed
Sponsors
Universitair Ziekenhuis Brussel
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed malignant melanoma; 2. AJCC Stage IIIC or IV melanoma with evaluable disease; 3. Treatment with an immune checkpoint inhibitor; 4. Willing and able to give written informed consent; 5. Accessible for treatment and follow-up;
Exclusion criteria
* non
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Baseline demographic data, prior disease history, nature of ICI therapy, treatment disposition, adverse events | 1year | Baseline demographic data, prior disease history, nature of ICI therapy, treatment disposition, adverse events |
| Tumor response according to the RECISTv1.1 and irRC criteria | 1 year | Tumor response according to the RECISTv1.1 and irRC criteria |
| Survival (PFS, and OS) by Kaplan-Meier estimates | 1year | Survival (PFS, and OS) by Kaplan-Meier estimates |
| 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 | 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 |
Countries
Belgium
Contacts
Primary ContactBart Neyns, MD; PhD
Backup ContactYanina Jansen, MD
Outcome results
None listed