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Anti-CD20 (Cluster of Differentiation Antigen 20) Therapy to Treat Metastatic Melanoma

NCT01376713 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2015-10-06

No results posted yet for this study

Summary

The purpose of this study is to assess the overall disease control rate of Ofatumumab wo/w Dacarbazine in subjects with American Joint Committee on Cancer (AJCC 2009) unresectable stage III or stage IV melanoma.

Conditions

  • Stage III Melanoma
  • Stage IV Melanoma

Interventions

BIOLOGICAL

Ofatumumab

Ofatumumab will be administered at a dose of 1000mg iv weekly for 8 weeks and q4w for another 16 weeks

BIOLOGICAL

Ofatumumab plus Dacarbazine

Ofatumumab will be administered at a dose of 1000mg iv weekly for 8 weeks and q4w for another 16 weeks. Dacarbazine administered q4w at a dose of 1000mg/m2, 4 days before next administration of Ofatumumab for 24 weeks.

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Stephan N Wagner, MD · Medical University of Vienna

  • Klemens Rappersberger, Prof. Dr. · Hospital Rudolfstiftung

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2015-01-31
Completion
2015-05-31

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01376713 on ClinicalTrials.gov