NCT00412828 (CLINICAL TRIAL / GLEMBATUMUMAB VEDOTIN / CDX-011 / CR011-VCMMAE)

Study Title
A Phase I/II Study of CR011-vcMMAE in Subjects With Unresectable Stage III or Stage IV Melanoma (NCT00412828)

Trial Description
This study will evaluate the safety, tolerability and pharmacokinetics of glembatumumab vedotin (also known as CDX-011 or CR011-vcMMAE) in patients who have unresectable stage III or stage IV melanoma and have failed no more than 1 line of prior cytotoxic therapy. CR011-vcMMAE will be administered intravenously (IV) once every 3 weeks at escalating doses until the maximum tolerated dose (MTD) is reached.

Once the MTD is defined, 18-32 patients will be enrolled to further evaluate the safety and efficacy of CR011-vcMMAE at this dose level. Additional dosing schedules of CR011-vcMMAE will also be explored.

This trial is sponsored by Celldex Therapeutics.

Study Data

  • Condition: Melanoma
  • Interventions:
  • Phase: I & II
  • Enrollment: 117
  • Start: June 2006
  • Completion: May 2011
  • Last verified: February 2015

Study Schematic 

NCT00412828 (CLINICAL TRIAL / GLEMBATUMUMAB VEDOTIN / CDX-011 / CR011-VCMMAE)


Last Editorial review: July 29, 2016
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.

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