CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 327 enrolled
Drug / intervention
CDX-011 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01997333
NCT01997333Phase 2Completed
CompareCT.gov

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

Celldex Therapeutics·interventional·Posted Nov 28, 2013·Updated Mar 8, 2019

In Brief

A Phase 2 clinical trial evaluating CDX-011 and Capecitabine for Metastatic gpNMB Over-expressing Triple Negative Breast Cancer. Completed, enrolled 327 participants across 140 sites in 9 countries.

Detailed Summary

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), and whose tumor cells make 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic gpNMB Over-expressing Triple Negative Breast Cancer
CountriesAustralia, Belgium, Canada, France, Germany, Italy, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 28, 2013
Enrollment StartNov 1, 2013
Primary CompletionNov 30, 2017
Study CompletionAug 7, 2018
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 12.6 years ago

Interventions

CDX-011drug

Capecitabinedrug