METRIC a study in GPNMB over expressing triple negative breast cancer

• Research type

  Research Study

• Full title

  A Randomized Multicenter Pivotal Study of CDX-011 (CR011-vcMMAE) in Patients with Metastatic, GPNMB Over-Expressing, Triple-Negative Breast Cancer (The “METRIC” Study)

• IRAS ID

  192795

• Contact name

  Peter Schmid

• Contact email

  p.schmid@qmul.ac.uk

• Sponsor organisation

  Celldex Therapeutics, Inc

• Eudract number

  2015-003693-33

• Duration of Study in the UK

  5 years, 0 months, 1 days

• Research summary

  This is a randomised, open-label study of CDX011-04 compared to capecitabine. Capecitabine is a form of chemotherapy given in tablet that is routinely used to treat metastatic breast cancer. CDX-011 is an experimental drug combining an antibody that binds directly to cancer cells and chemotherapy drug linked with the antibody to specifically deliver it to the cancer cells.
  The purpose of this study is to see whether CDX-011 is effective in treating patients who have advanced Triple-Negative Breast Cancer (TNBC) (a subtype of breast cancer that does not respond to endocrine therapy) that contains the protein gpNMB, and to examine the side effects associated with CDX-011 treatment.
  Data collected during prior clinical studies show CDX-011 is generally well-tolerated and active in patients with advanced breast cancer.
  Participants enrolled in this study will have been diagnosed with metastatic TNBC and have received no more than 2 prior chemotherapy regimens for advanced breast cancer.
  Approximately 300 patients will be enrolled in this study globally.
  Eligible participants will be randomised on a ratio of 2:1 to receive CDX-011 or Capecitabine. Depending on which group they are assigned, they will either receive CDX-011 given into the vein (IV) once every 3 weeks or will receive capecitabine, which is taken as tables for the first 14 days of each cycle. Each cycle is 21 days. Treatment will continue as long as there are no serious side effects and their cancer has not worsened, haven’t withdrawn, study completion or study termination. Participation in the study is expected to last up to 5 years. This includes screening, treatment visits, disease assessment and end of treatment. After study discontinuation, participants will be followed up every 3 months until death, loss to follow-up, withdrawal or study termination

  Study procedures will include physical examinations, vital signs, ECG, disease assessment, questionnaires and blood and urine samples.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  15/LO/2124

• Date of REC Opinion

  18 Jan 2016

• REC opinion

  Further Information Favourable Opinion