A Phase II, Randomized, Multicenter Study of CDX-011 (CR011-vcMMAE) in Patients With Advanced GPNMB-expressing Breast Cancer (EMERGE)

NCT01156753 Phase 2 COMPLETED

The main purpose of this study is to see whether CDX-011 is effective in treating patients who have advanced breast cancer that makes a protein called glycoprotein NMB (GPNMB), and who have already received (or were not candidates for) all available approved therapies for their breast cancer. This study will also further characterize the safety of CDX-011 treatment in this patient population.

Details

Lead sponsor	Celldex Therapeutics
Phase	Phase 2
Status	COMPLETED
Enrolment	120
Start date	2010-07
Completion	2012-11

Conditions

• Breast Cancer

Interventions

• CDX-011
• "Investigator's Choice" chemotherapy

Primary outcomes

• Objective response rate — 6 or more weeks following treatment initiation
  The objective response rate (ORR) is defined as the proportion of patients who achieve radiographic partial or complete response (PR or CR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guideline.

Countries

United States