Study of CDX-011 (CR011-vcMMAE) in Patients With Advanced GPNMB Over-expressing Cancer. (METRIC)
The main purpose of this study is to see whether CDX-011 (glembatumumab vedotin, an antibody-drug conjugate) is effective in treating patients who have advanced Triple-Negative Breast Cancer (TNBC; i.e., tumors lacking expression of estrogen, progesterone and HER2 receptors), and whose tumor cells makes a protein called glycoprotein NMB (GPNMB), which CDX-011 binds to. The study will also further characterize the safety of CDX-011 treatment in this patient population.
Condition Intervention Phase
Breast Cancer Drug: CDX-011 Phase 2
Metastatic GPNMB Over-expressing Triple Negative Breast Cancer.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official 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)|
- Objective Response Rate (ORR) [ Time Frame: Six weeks following treatment initiation. ] [ Designated as safety issue: No ]ORR is defined as the proportion of patients who achieve best overall response of complete or partial response according to RECIST 1.1.
- Progression Free Survival (PFS) [ Time Frame: At least 18 months following treatment initiation. ] [ Designated as safety issue: No ]PFS is defined as the time from randomization to the earlier of disease progression or death due to any cause.
- Duration of Response (DOR) [ Time Frame: At least 18 months following treatment initiation ] [ Designated as safety issue: No ]
- Overall Survival (OS) [ Time Frame: During treatment and 3 months from end of treatment through end of study or approximately up to 5 years. ] [ Designated as safety issue: No ]
- Adverse Events (AE) [ Time Frame: Usually following at least 1 cycle of study treatment (1 dose of CDX-011 or capecitabine and until discontinuation of follow-up) ] [ Designated as safety issue: Yes ]The percentage of patients experiencing one or more adverse events will be summarized by treatment arm, relationship to study drug, and severity.
- Pharmacokinetic (PK) [ Time Frame: Following 1 dose of CDX-011. ] [ Designated as safety issue: Yes ]Concentration of the antibody-drug conjugate, total antibody and free MMAE will be determined.
|Study Start Date:||November 2013|
|Estimated Study Completion Date:||September 2016|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Capecitabine
Capecitabine will be administered on Days 1 through 14 of each 21 day cycle.
Capecitabine will be administered on Days 1 through 14 of each 21 day cycle
Experimental: Drug: CDX-011
CDX-011 administered as an intravenous infusion on Day 1 of each 21 day cycle.
CDX-011 is administered as an intravenous infusion on Day 1 of each 21 day cycle
CDX-011 consists of an antibody attached to a drug, monomethyl auristatin E (MMAE), that can kill cancer cells. The antibody delivers the drug to cancer cells by attaching to a protein called glycoprotein NMB (GPNMB) that is expressed on the cancer cell. The MMAE is then released inside of the cell, where it interferes with cell growth and may lead to cell death.
This study will examine the effectiveness and safety of CDX-011 in patients with advanced TNBC that makes the GPNMB protein. The effect of CDX-011 will be compared to treatment with capecitabine.
Eligible patients who enroll in the study will be randomly assigned (by chance) to receive treatment with CDX-011 or with capecitabine. For every three patients enrolled, two will receive CDX-011 and one will receive treatment with capecitabine. All patients enrolled in the study will be closely monitored to determine if their cancer is responding to treatment and for any side effects that may occur.