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

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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;

Locations
Other Locations
Belgium
UZ Brussel
RECRUITING
Jette
UZ Brussel
RECRUITING
Jette
Contact Information
Primary
Bart Neyns, MD; PhD
bart.neyns@uzbrussel.be
024746040
Backup
Yanina Jansen, MD
yanina.jansen@uzbrussel.be
024746040
Time Frame
Start Date: 2014-10
Estimated Completion Date: 2025-12
Participants
Target number of participants: 200
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Universitair Ziekenhuis Brussel

This content was sourced from clinicaltrials.gov

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