Immuno-monitoring of Patients With Metastatic Melanoma (AJCC Stadium IV) Under Chemotherapy

Completed

• Conditions: Immuno-monitoring

• Registration Number: NCT02332642
• Lead Sponsor: Universitätsmedizin Mannheim

Brief Summary

This pilot clinical trial aims at evaluating immuno-modulating effects of palliative treatment with specifically dosed standard chemotherapeutics in patients with metastatic melanoma (AJCC stage IV) by assessing myeloid-derived suppressor cells' (MDSCs) count and activity.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2015-01-05
• Study First Submitted QC: 2015-01-06
• Study First Posted: 2015-01-07
• Primary Completion: 2016-12
• Study Completion: 2016-12-31
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-06
• Last Update Posted: 2017-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• histologically defined metastatic melanoma patients (AJCC stage IV)
• aged 18 to 80 years
• at least one prior systemic anti-melanoma therapy; if BRAFV600 positive, at least one prior BRAFi therapy

Exclusion Criteria

• therapy-naive patients
• any contra-indications for (specific) systemic chemotherapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immuno-monitoring	Immediate

Trial Locations

Locations (1)

Universitätsmedizin Mannheim, Klinik für Dermatologie, Venerologie und Allergologie; 🇩🇪 Mannheim, Germany