NCT02332642

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
Last Updated

March 7, 2017

Status Verified

March 1, 2017

Enrollment Period

2.1 years

First QC Date

January 5, 2015

Last Update Submit

March 6, 2017

Conditions

Immuno-monitoring

Outcome Measures

Primary Outcomes (1)

  • Immuno-monitoring

    Immediate

Interventions

Immuno-monitoringOTHER

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Metastatic melanoma patients (AJCC stage IV)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsmedizin Mannheim, Klinik für Dermatologie, Venerologie und Allergologie

Mannheim, 68167, Germany

Location

Related Links

Study Officials

  • Christoffer Gebhardt, M.D.

    Universitätsmedizin Mannheim

    PRINCIPAL INVESTIGATOR

  • Jochen Utikal, M.D.

    Universitätsmedizin Mannheim

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 5, 2015

First Posted

January 7, 2015

Study Start

November 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 31, 2016

Last Updated

March 7, 2017

Record last verified: 2017-03

Locations

DE(1)