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

Recruiting

• Conditions: Malignant Melanoma

• Registration Number: NCT02673970
• Lead Sponsor: Universitair Ziekenhuis Brussel

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

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2016-02-01
• Study First Submitted QC: 2016-02-01
• Study First Posted: 2016-02-04
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-16
• Last Update Posted: 2020-12-17
• Primary Completion: 2025-09
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Tumor response according to the RECISTv1.1 and irRC criteria	1 year	Tumor response according to the RECISTv1.1 and irRC criteria
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

Trial Locations

Locations (1)

UZ Brussel; 🇧🇪 Jette, Brussels, Belgium