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Study of Glembatumumab Vedotin (CDX-011) in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer (METRIC)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01997333
First Posted: November 28, 2013
Last Update Posted: August 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Celldex Therapeutics
  Purpose
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.

Condition Intervention Phase
Metastatic gpNMB Over-expressing Triple Negative Breast Cancer Drug: CDX-011 Drug: Capecitabine Phase 2

Access to an investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)

Resource links provided by NLM:


Further study details as provided by Celldex Therapeutics:

Primary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: Evaluated every 6 - 9 weeks following treatment initiation ]
    PFS is defined as the time from randomization to the earlier of disease progression or death due to any cause.


Secondary Outcome Measures:
  • Objective Response Rate (ORR) [ Time Frame: Evaluated every 6 - 9 weeks following treatment initiation ]
    ORR is defined as the proportion of patients who achieve best overall response of complete or partial response according to RECIST 1.1.

  • Duration of Response (DOR) [ Time Frame: Evaluated every 6 - 9 weeks following treatment initiation ]
  • Overall Survival (OS) [ Time Frame: During treatment and 3 months from end of treatment through end of study or approximately up to 5 years. ]
  • 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) ]
    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. ]
    Concentration of the antibody-drug conjugate, total antibody and free MMAE will be determined.


Enrollment: 327
Study Start Date: November 2013
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Capecitabine
Capecitabine will be administered on Days 1 through 14 of each 21 day cycle.
Drug: Capecitabine
Experimental: Drug: CDX-011
CDX-011 administered as an intravenous infusion on Day 1 of each 21 day cycle.
Drug: CDX-011

Detailed Description:

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 efficacy 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Among other criteria, patients must meet all of the following conditions to be eligible for the study:

  1. Diagnosed with metastatic (i.e., cancer that has spread) TNBC

    • minimal or no expression of estrogen and progesterone receptors (ER/PR) <10% of cells positive by immunohistochemistry
    • HER 2 staining 0 or 1+ by IHC or copy number <4.0 signals/cell
  2. Documented progression of disease based on radiographic, clinical or pathologic assessment during or subsequent to the last anticancer regimen received.
  3. Breast cancer tumor confirmed to express gpNMB. This will be determined by submitting a tissue sample from the advanced (locally advanced/recurrent or metastatic) disease setting to a central laboratory for analysis.
  4. Received no more than two prior chemotherapy treatments for advanced (locally advanced/recurrent or metastatic) breast cancer.
  5. Prior chemotherapy treatment must have contained an anthracycline (e.g. doxorubicin or Doxil) if clinically indicated and a taxane (eg: Taxol).
  6. ECOG performance status of 0 - 1.
  7. Adequate bone marrow, liver and renal function.

Exclusion:

Among other criteria, patients who meet any of the following conditions are NOT eligible for the study:

  1. Progression/recurrence of breast cancer during or within 3 months of completion of neoadjuvant or adjuvant chemotherapy.
  2. Ongoing neuropathy or other chemotherapy or radiation-related toxicities that are moderate (Grade 2) or worse in severity.
  3. Known brain metastases, unless previously treated and asymptomatic for 2 months and not progressive in size or number for 2 months.
  4. Significant cardiovascular disease.
  5. Previously received capecitabine and discontinued due to progression or intolerance; previously received CDX-011 or other MMAE containing agents.
  6. Active systemic infection requiring treatment. Infection controlled by oral therapy will not be exclusionary.
  7. Chronic use of systemic corticosteroids.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01997333


  Hide Study Locations
Locations
United States, Alabama
Alabama Oncology
Birmingham, Alabama, United States, 35211
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
University of South Alabama Cancer Research Insititute
Mobile, Alabama, United States, 36604
United States, Arizona
Arizona Cancer Research Alliance
Glendale, Arizona, United States, 85304
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Compassionate Care Research Group
Fountain Valley, California, United States, 92708
St. Jude Heritage Medical Group
Fullerton, California, United States, 92835
USC Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033
University of California Davis Medical Center
Sacramento, California, United States, 95817
Pacific Cancer Care
Salinas, California, United States, 93901
University of California San Francisco
San Francisco, California, United States, 94115
Kaiser Permaente
Vallejo, California, United States, 94589
Wellness Hematology Oncology
West Hills, California, United States, 91307
United States, Florida
University of Miami Miller School of Medicine
Deerfield Beach, Florida, United States, 33442
Florida Cancer Specialists South
Fort Myers, Florida, United States, 33916
Memorial Regional Hospital
Hollywood, Florida, United States, 33021
Baptist Cancer Institute
Jacksonville, Florida, United States, 32207
Florida Cancer Specialists
New Port Richey, Florida, United States, 34655
Tallahassee Memorial HealthCare
Tallahassee, Florida, United States, 32308
United States, Georgia
Peachtree Hematology Oncology Consultants, PC
Atlanta, Georgia, United States, 30318
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
Georgia Cancer Specialists Clinic
Atlanta, Georgia, United States, 30341
Northwest Georgia Oncology Centers P.C.
Marietta, Georgia, United States, 30060
Summit Cancer Care, PC-Savannah
Savannah, Georgia, United States, 31405
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Ingalis Memorial Hospital
Harvey, Illinois, United States, 60426
Illinois CancerCare
Peoria, Illinois, United States, 60615
Orchard Healthcare Research Inc.
Skokie, Illinois, United States, 60077
Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Louisiana
Lafayette General Medical Center
Lafayette, Louisiana, United States, 70503
Hematology and Oncology Specialists
Marrero, Louisiana, United States, 70072
Louisiana State University Health New Orleans
New Orleans, Louisiana, United States, 70112
Oschner Medical Center
New Orleans, Louisiana, United States, 70121
United States, Maryland
Anne Arundel Medical Center
Annapolis, Maryland, United States, 21401
University of Maryland
Baltimore, Maryland, United States, 21201
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21287-0013
Frederick Memorial Hospital
Frederick, Maryland, United States, 21701
Holy Cross Hospital
Silver Spring, Maryland, United States, 20902
United States, Minnesota
Virginia Piper Cancer Center
Minneapolis, Minnesota, United States, 55407
United States, Missouri
HCA Midwest Health
Kansas City, Missouri, United States, 64132
Washington University Dept of Oncology
Saint Louis, Missouri, United States, 63110
St John's Mercy Medical Center
Saint Louis, Missouri, United States, 63141
United States, New Jersey
Hunterdon Regional Cancer Center
Flemington, New Jersey, United States, 08822
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Clinical Research Alliance, Inc.
Lake Success, New York, United States, 11042
ProHEALTH Care Associates
Lake Success, New York, United States, 11042
Beth Isreal Medical Center
New York, New York, United States, 10011
Weill Cornell Medical Center
New York, New York, United States, 10021
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
United States, North Carolina
Novant Health
Charlotte, North Carolina, United States, 28204
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Oncology Hematology Care
Cincinnati, Ohio, United States, 45242
Cleveland Clinic-Taussig Cancer Institute-R35
Cleveland, Ohio, United States, 44195
Signal Point Clinical Research Center, LLC
Middletown, Ohio, United States, 45042
United States, Oklahoma
Mercy Clinic of Oklahoma
Oklahoma City, Oklahoma, United States, 73120
United States, Oregon
Oregon Health and Science University
Beaverton, Oregon, United States, 97006
United States, Pennsylvania
St Mary Medical Center
Langhorne, Pennsylvania, United States, 19047
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Guthrie Clinical Research
Sayre, Pennsylvania, United States, 18840
United States, South Carolina
Charleston Hematology Oncology Associates (CHOA)
Charleston, South Carolina, United States, 29414
United States, Tennessee
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, United States, 37404
Center for Biomedical Research, LLC
Knoxville, Tennessee, United States, 37909
Sarah Cannon Cancer Center
Nashville, Tennessee, United States, 37203
United States, Texas
Oncology Hematology Consultants PA
Fort Worth, Texas, United States, 76104
Baylor College of Medicine
Houston, Texas, United States, 77030
Houston Methodist Cancer Center
Houston, Texas, United States, 77030
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Texas Tech University Health Sciences Center
Lubbock, Texas, United States, 79430
United States, Washington
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Australia, New South Wales
St. Vincents Hospital Sydney
Darlinghurst, New South Wales, Australia, 2010
Macquarie University
Macquarie Park, New South Wales, Australia, 2109
The Tweed Hospital
Tweed Heads, New South Wales, Australia, 2485
Sydney Adventist Hospital
Wahroonga, New South Wales, Australia, 2076
Australia, Queensland
Townsville Hospital
Douglas, Queensland, Australia, 4814
Australia, Victoria
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Western Hospital
Footscray, Victoria, Australia, 3011
Joint Ludwig-Austin Dept of Medical Oncology
Hieidelberg, Victoria, Australia, 3084
Epworth Health Care
Richmond, Victoria, Australia, 3121
Belgium
GasthuisZusters Antwerpen
Wilrijk, Antwerpen, Belgium, 2610
Grand Hopital de Charleroi asbl
Charleroi, Hainaut, Belgium, 6000
UZ Leuven
Leuven, Vlaams Brabant, Belgium, 3000
Clinique Edith Cavell
Brussels Capital Region, Belgium, 1180
Institute Jules Bordet
Bruxelles, Belgium, 1000
Canada, Ontario
Algoma District Cancer Program Sault Area Hospital
Sault Ste Marie, Ontario, Canada, P6B-0A8
Sunnybrook Health Sciences Centre Odette Cancer Center
Toronto, Ontario, Canada, M4N 3M5
St. MIchael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
Sir Mortimer B Davis Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Universite de Montreal-Hopital Du Sacre-Coeur De Montreal
Montreal, Quebec, Canada, H4J 1C5
France
Centre Antoine Lacassagne Centre Régional de Lutte Contre Le Cancer
Nice, Alpes-Maritimes, France, 06189
Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes
Lyon, Rhône, France, 69373
Centre Jean Bernard Clinique Victor Hugo
Le Mans, Sarthe, France, 72000
Institut Sainte Catherine
Avignon, France, 84000
Centre Oscar Lambret
Lille, France, 59000
Hôpital de La Croix Rousse
Lyon, France, 69317
Centre Hospitalier de Mont de Marson - Hôpital Layné
Mont de Marsan, France, 40000
Institut Curie
Paris, France, 75005
Hospices Civils de Lyon
Pierre Benite, France, 69495
Centre Hospitalier Prive Saint-Gregoire
St Gregoire, France, 35768
Germany
Klinikum Essingen GmbH
Esslingen Am Neckar, Baden-Wurttemberg, Germany, 73730
Helios Klinikum Berlin Buch
Berlin, Germany, 13125
Kliniken der Stadt Koeln gGmbH - Krankenhaus Holweide
Cologne, Germany, 51067
Universitätsklinikum Düsseldorf
Düsseldorf, Germany, 40225
Universitätsklinikum Erlangen
Erlangen, Germany, 91054
Klinikum Frankfurt Höchst GmbH
Frankfurt am Main, Germany, 65929
Martin-Luther-Universität Halle-Wittenberg
Halle an der Saale, Germany, 06120
Universität Des Saarlandes
Homberg, Germany, 66421
Rotkreuzklinikum München
Munich, Germany, 80637
Universitätsklinikum Münster
Münster, Germany, 48149
Hämatologisch-Onkologische Schwerpunktpraxis
Troisdorf, Germany, 53840
Italy
Istituto Scientifico romagnolo Per Lo Studio E La Cura Del Tumori IRST
Meldola, Emilia-Romagna, Italy, 47014
Fondazione Policlinico Universitario A Gemelli
Roma, Lazio, Italy, 00168
Azienda Ospedaliera Fatebenefratelli e Oftaimico
Milano, Lombardia, Italy, 20121
Istituto Nazionale Dei Tumori
Milano, Lombardia, Italy, 20133
Istituto Europeo Di Oncologia
Milano, Lombardia, Italy, 20141
Istituto Clinico Humanitas
Rozzano, Lombardia, Italy, 20089
Centro Di Riferimento Oncologico
Aviano, Pordenone, Italy, 33081
Azienda Ospedaliera Universitaria Pisana
Pisa, Toscana, Italy, 56126
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
Bologna, Italy, 40138
Azienda Ospedaliera Citta della Salute e della Scienza de Torino
Torino, Italy, 10126
Spain
Hospital Universitario Central de Asturias
Oviedo, Asturias, Spain, 33011
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, Spain, 08208
Consorcio Hospitalario Provincial de Castellon
Castellon de La Plana, Castellón, Spain, 12002
Hospital Universitario Ramon y Cajal
Madrid, Communidad Delaware, Spain, 28034
Hospital Regional Universitario de Malaga - Hospital General
Malaga, Málaga, Spain, 29011
Hospital Universitario Vall d'Hebron
Barcelona, Spain, 08035
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
MD Anderson Cancer Center Madrid-Espana
Madrid, Spain, 28033
Hospital Clinico San Carlos
Madrid, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
United Kingdom
Barts Health NHS Trust
London, City of London, United Kingdom, EC1A 7BE
Derriford Hospital
Plymouth, Devon, United Kingdom, PL6 8DH
Royal Sussex County Hospital
Brighton, East Sussex, United Kingdom, BN2 5BE
Beatson West of Scotland Cancer Centre
Glasgow, Glasgow City, United Kingdom, G12 0YN
Blackpool Victoria Hospital
Blackpool, Lancashire, United Kingdom, FY3 8NR
University College London
London, London, City of, United Kingdom, NW1 2PG
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
Sarah Cannon Research Institute UK
City of London, United Kingdom, W1G 6AD
Sponsors and Collaborators
Celldex Therapeutics
  More Information

Responsible Party: Celldex Therapeutics
ClinicalTrials.gov Identifier: NCT01997333     History of Changes
Other Study ID Numbers: CDX011-04
First Submitted: November 18, 2013
First Posted: November 28, 2013
Last Update Posted: August 30, 2017
Last Verified: August 2017

Keywords provided by Celldex Therapeutics:
Metastatic Breast Cancer
Locally advanced breast cancer
Breast cancer
Triple negative
Estrogen
Progesterone
HER2 receptors
Targeted treatment for breast cancer
Antibody-drug-conjugate
Breast Neoplasms
CDX-011
gpNMB
METRIC
Glembatumumab vedotin
Triple Negative Breast Cancer
TNBC

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Antibodies, Monoclonal
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs