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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02673970
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Universitair Ziekenhuis Brussel
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Bart NEyns, MD; PhD
Principal Investigator Affiliation	Universitair Ziekenhuis Brussel
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Belgium
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Malignant Melanoma

Additional Details

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

Arms & Interventions

Arms

: observational arm

From start treatment till date of death or date of cure, the patient will be followed for survival and adverse events on pembrolizumab

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

UZ Brussel, Jette, Brabant, Belgium

Status

Recruiting

Address

UZ Brussel

Jette, Brabant, 1090

Site Contact

Bart Neyns, Phd,Md

[email protected]

0032(0)2477 64 15

UZ Brussel, Jette, Brussels, Belgium

Status

Recruiting

Address

UZ Brussel

Jette, Brussels, 1090

Site Contact

Katrien Vandenbossche, study nurse

[email protected]

0032 2 477 54 47

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