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Metastatic gpNMB Over-expressing Triple Negative Breast CancerPhase 2METRICNCT01997333

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

A Phase 2 study testing CDX-011 and Capecitabine in people with Metastatic gpNMB Over-expressing Triple Negative Breast Cancer, run by Celldex Therapeutics at 140 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CDX-011 and Capecitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
327 participants
Where
140 sitesin 9 countries
Study dates
Nov 2013to 7 Aug 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Among other criteria, patients must meet all of the following conditions to be eligible for the study:
  • 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
  • Documented progression of disease based on radiographic, clinical or pathologic assessment during or subsequent to the last anticancer regimen received.
  • 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.
Show all 10Show fewer
  • Received no more than two prior chemotherapy treatments for advanced (locally advanced/recurrent or metastatic) breast cancer.
  • Prior chemotherapy treatment must have contained an anthracycline (e.g. doxorubicin or Doxil) if clinically indicated and a taxane (eg: Taxol).
  • ECOG performance status of 0 - 1.
  • Adequate bone marrow, liver and renal function.

Who cannot join

  • Among other criteria, patients who meet any of the following conditions are NOT eligible for the study:
  • Progression/recurrence of breast cancer during or within 3 months of completion of neoadjuvant or adjuvant chemotherapy.
  • Ongoing neuropathy or other chemotherapy or radiation-related toxicities that are moderate (Grade 2) or worse in severity.
  • Known brain metastases, unless previously treated and asymptomatic for 2 months and not progressive in size or number for 2 months.
  • Significant cardiovascular disease.
  • Previously received capecitabine and discontinued due to progression or intolerance; previously received CDX-011 or other MMAE containing agents.
  • Active systemic infection requiring treatment. Infection controlled by oral therapy will not be exclusionary.
  • Chronic use of systemic corticosteroids.

Trial locations and contacts

140 sites in 9 countries.

140 sites in 9 countries

United States71 sites

  • Anne Arundel Medical Center

    Annapolis, Maryland, 21401

  • Peachtree Hematology Oncology Consultants, PC

    Atlanta, Georgia, 30318

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia, 30322

  • Georgia Cancer Specialists Clinic

    Atlanta, Georgia, 30341

  • University of Maryland

    Baltimore, Maryland, 21201

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21287-0013

  • Oregon Health and Science University

    Beaverton, Oregon, 97006

  • Alabama Oncology

    Birmingham, Alabama, 35211

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Charleston Hematology Oncology Associates (CHOA)

    Charleston, South Carolina, 29414

  • Novant Health

    Charlotte, North Carolina, 28204

  • Chattanooga Oncology Hematology Associates

    Chattanooga, Tennessee, 37404

  • University of Chicago

    Chicago, Illinois, 60637

  • Oncology Hematology Care

    Cincinnati, Ohio, 45242

  • Cleveland Clinic-Taussig Cancer Institute-R35

    Cleveland, Ohio, 44195

  • University of Miami Miller School of Medicine

    Deerfield Beach, Florida, 33442

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Hunterdon Regional Cancer Center

    Flemington, New Jersey, 08822

  • Florida Cancer Specialists South

    Fort Myers, Florida, 33916

  • Oncology Hematology Consultants PA

    Fort Worth, Texas, 76104

  • Compassionate Care Research Group

    Fountain Valley, California, 92708

  • Frederick Memorial Hospital

    Frederick, Maryland, 21701

  • St. Jude Heritage Medical Group

    Fullerton, California, 92835

  • Arizona Cancer Research Alliance

    Glendale, Arizona, 85304

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Ingalis Memorial Hospital

    Harvey, Illinois, 60426

  • Memorial Regional Hospital

    Hollywood, Florida, 33021

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Houston Methodist Cancer Center

    Houston, Texas, 77030

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • Baptist Cancer Institute

    Jacksonville, Florida, 32207

  • HCA Midwest Health

    Kansas City, Missouri, 64132

  • Center for Biomedical Research, LLC

    Knoxville, Tennessee, 37909

  • Lafayette General Medical Center

    Lafayette, Louisiana, 70503

  • Clinical Research Alliance, Inc.

    Lake Success, New York, 11042

  • ProHEALTH Care Associates

    Lake Success, New York, 11042

  • St Mary Medical Center

    Langhorne, Pennsylvania, 19047

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • USC Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90033

  • Texas Tech University Health Sciences Center

    Lubbock, Texas, 79430

  • Northwest Georgia Oncology Centers P.C.

    Marietta, Georgia, 30060

  • Hematology and Oncology Specialists

    Marrero, Louisiana, 70072

  • Signal Point Clinical Research Center, LLC

    Middletown, Ohio, 45042

  • Virginia Piper Cancer Center

    Minneapolis, Minnesota, 55407

  • University of South Alabama Cancer Research Insititute

    Mobile, Alabama, 36604

  • Sarah Cannon Cancer Center

    Nashville, Tennessee, 37203

  • Louisiana State University Health New Orleans

    New Orleans, Louisiana, 70112

  • Oschner Medical Center

    New Orleans, Louisiana, 70121

  • Florida Cancer Specialists

    New Port Richey, Florida, 34655

  • Beth Isreal Medical Center

    New York, New York, 10011

  • Weill Cornell Medical Center

    New York, New York, 10021

  • Mercy Clinic of Oklahoma

    Oklahoma City, Oklahoma, 73120

  • Illinois CancerCare

    Peoria, Illinois, 60615

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • University of California Davis Medical Center

    Sacramento, California, 95817

  • Pacific Cancer Care

    Salinas, California, 93901

  • University of California San Francisco

    San Francisco, California, 94115

  • Summit Cancer Care, PC-Savannah

    Savannah, Georgia, 31405

  • Guthrie Clinical Research

    Sayre, Pennsylvania, 18840

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Holy Cross Hospital

    Silver Spring, Maryland, 20902

  • Orchard Healthcare Research Inc.

    Skokie, Illinois, 60077

  • Washington University Dept of Oncology

    St Louis, Missouri, 63110

  • St John's Mercy Medical Center

    St Louis, Missouri, 63141

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • Tallahassee Memorial HealthCare

    Tallahassee, Florida, 32308

  • Arizona Cancer Center

    Tucson, Arizona, 85724

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • Kaiser Permaente

    Vallejo, California, 94589

  • Wellness Hematology Oncology

    West Hills, California, 91307

Other trials in United States

Germany11 sites

  • Helios Klinikum Berlin Buch

    Berlin, 13125

  • Kliniken der Stadt Koeln gGmbH - Krankenhaus Holweide

    Cologne, 51067

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225

  • Universitätsklinikum Erlangen

    Erlangen, 91054

  • Klinikum Essingen GmbH

    Esslingen am Neckar, Baden-Wurttemberg, 73730

  • Klinikum Frankfurt Höchst GmbH

    Frankfurt am Main, 65929

  • Martin-Luther-Universität Halle-Wittenberg

    Halle, 06120

  • Universität Des Saarlandes

    Homberg (Efze), 66421

  • Rotkreuzklinikum München

    Munich, 80637

  • Universitätsklinikum Münster

    Münster, 48149

  • Hämatologisch-Onkologische Schwerpunktpraxis

    Troisdorf, 53840

Other trials in Germany

Spain11 sites

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Consorcio Hospitalario Provincial de Castellon

    Castellon, Castellón, 12002

  • Hospital Universitario Ramon y Cajal

    Madrid, Communidad Delaware, 28034

  • MD Anderson Cancer Center Madrid-Espana

    Madrid, 28033

  • Hospital Clinico San Carlos

    Madrid

  • Hospital Regional Universitario de Malaga - Hospital General

    Málaga, Málaga, 29011

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

  • Corporacio Sanitaria Parc Tauli

    Sabadell, Barcelona, 08208

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

France10 sites

  • Institut Sainte Catherine

    Avignon, 84000

  • Centre Jean Bernard Clinique Victor Hugo

    Le Mans, Sarthe, 72000

  • Centre Oscar Lambret

    Lille, 59000

  • Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes

    Lyon, Rhône, 69373

  • Hôpital de La Croix Rousse

    Lyon, 69317

  • Centre Hospitalier de Mont de Marson - Hôpital Layné

    Mont-de-Marsan, 40000

  • Centre Antoine Lacassagne Centre Régional de Lutte Contre Le Cancer

    Nice, Alpes-Maritimes, 06189

  • Institut Curie

    Paris, 75005

  • Hospices Civils de Lyon

    Pierre-Bénite, 69495

  • Centre Hospitalier Prive Saint-Gregoire

    Saint-Grégoire, 35768

Other trials in France

Italy10 sites

  • Centro Di Riferimento Oncologico

    Aviano, Pordenone, 33081

  • Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi

    Bologna, 40138

  • Istituto Scientifico romagnolo Per Lo Studio E La Cura Del Tumori IRST

    Meldola, Emilia-Romagna, 47014

  • Azienda Ospedaliera Fatebenefratelli e Oftaimico

    Milan, Lombardy, 20121

  • Istituto Nazionale Dei Tumori

    Milan, Lombardy, 20133

  • Istituto Europeo Di Oncologia

    Milan, Lombardy, 20141

  • Azienda Ospedaliera Universitaria Pisana

    Pisa, Tuscany, 56126

  • Fondazione Policlinico Universitario A Gemelli

    Rome, Lazio, 00168

  • Istituto Clinico Humanitas

    Rozzano, Lombardy, 20089

  • Azienda Ospedaliera Citta della Salute e della Scienza de Torino

    Torino, 10126

Other trials in Italy

Australia9 sites

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • St. Vincents Hospital Sydney

    Darlinghurst, New South Wales, 2010

  • Townsville Hospital

    Douglas, Queensland, 4814

  • Western Hospital

    Footscray, Victoria, 3011

  • Joint Ludwig-Austin Dept of Medical Oncology

    Heidelberg, Victoria, 3084

  • Macquarie University

    Macquarie Park, New South Wales, 2109

  • Epworth Health Care

    Richmond, Victoria, 3121

  • The Tweed Hospital

    Tweed Heads, New South Wales, 2485

  • Sydney Adventist Hospital

    Wahroonga, New South Wales, 2076

Other trials in Australia

United Kingdom8 sites

  • Blackpool Victoria Hospital

    Blackpool, Lancashire, FY3 8NR

  • Royal Sussex County Hospital

    Brighton, East Sussex, BN2 5BE

  • Sarah Cannon Research Institute UK

    City of London, W1G 6AD

  • Beatson West of Scotland Cancer Centre

    Glasgow, Glasgow City, G12 0YN

  • Barts Health NHS Trust

    London, City of London, EC1A 7BE

  • University College London

    London, London, City of, NW1 2PG

  • Nottingham University Hospitals NHS Trust

    Nottingham, Nottinghamshire, NG5 1PB

  • Derriford Hospital

    Plymouth, Devon, PL6 8DH

Other trials in United Kingdom

Belgium5 sites

  • Institute Jules Bordet

    Brussels, 1000

  • Clinique Edith Cavell

    Brussels Capital Region, 1180

  • Grand Hopital de Charleroi asbl

    Charleroi, Hainaut, 6000

  • UZ Leuven

    Leuven, Vlaams Brabant, 3000

  • GasthuisZusters Antwerpen

    Wilrijk, Antwerpen, 2610

Other trials in Belgium

Canada5 sites

  • Sir Mortimer B Davis Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Universite de Montreal-Hopital Du Sacre-Coeur De Montreal

    Montreal, Quebec, H4J 1C5

  • Algoma District Cancer Program Sault Area Hospital

    Sault Ste. Marie, Ontario, P6B-0A8

  • Sunnybrook Health Sciences Centre Odette Cancer Center

    Toronto, Ontario, M4N 3M5

  • St. MIchael's Hospital

    Toronto, Ontario, M5B 1W8

Other trials in Canada

About this study

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)

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.

Read the 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.

Being tested
CDX-011, Capecitabine
Keywords
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
Medical subject headings
Breast Neoplasms, Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01997333
Study groupRoleWhat they receive
CapecitabineActive comparatorCapecitabine will be administered on Days 1 through 14 of each 21 day cycle.
Receives: Drug: Capecitabine
Drug: CDX-011ExperimentalCDX-011 administered as an intravenous infusion on Day 1 of each 21 day cycle.
Receives: Drug: CDX-011

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    PFS is defined as the time from randomization to the earlier of disease progression or death due to any cause. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or progression in a non-target lesion, or the appearance of new lesions. The primary analysis of PFS was based on PFS events determined retrospectively by the central independent review committee, blinded to treatment assignment and investigator assessments according to RECIST 1.1 criteria.

    Measured: Evaluated every 6 - 9 weeks following treatment initiation

Secondary outcomes (5)

  1. Objective Response Rate (ORR)

    ORR is defined as the percentage of patients who achieve best overall response of complete or partial response. The analysis of ORR was based on ORR events determined retrospectively by the central independent review committee, blinded to treatment assignment and investigator assessments according to RECIST 1.1 criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), Complete Response (CR) = Disappearance of all target lesions and non-target lesions, Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions with no progression in non-target lesions and no new lesions.

    Measured: Evaluated every 6 - 9 weeks following treatment initiation

  2. Duration of Response

    Duration of response (DOR) is the number of months from the time criteria are first met for either CR or PR, until the first date that PD is objectively documented. The analysis of DOR was determined retrospectively by the central independent review committee,blinded to treatment assignment and investigator assessments according to RECIST 1.1 criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), Complete Response (CR) = Disappearance of all target lesions and non-target lesions, Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions with no progression in non-target lesions and no new lesions.

    Measured: Evaluated every 6 - 9 weeks following treatment initiation

  3. Overall Survival

    Overall Survival (OS) is defined as the number of months from randomization to the date of death due to any cause.

    Measured: During treatment and 3 months from end of treatment through end of study or approximately up to 5 years.

  4. Adverse Events (AE)

    The percentage of patients experiencing one or more adverse events will be summarized by treatment arm, relationship to study drug, and severity.

    Measured: Usually following at least 1 cycle of study treatment (1 dose of CDX-011 or capecitabine and until discontinuation of follow-up)

  5. Pharmacokinetics (PK)

    Concentration of the antibody drug conjugate (ADC), total antibody (TA) and free MMAE will be determined.

    Measured: Following 1 dose of CDX-011.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2013 (estimated)
  2. Study startNov 2013
  3. Primary completion30 Nov 2017
  4. Study completion7 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
327 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01997333
Sponsor's protocol ID
CDX011-04
Acronym
METRIC
Status last verified
Mar 2019
First submitted
18 Nov 2013
Last updated
8 Mar 2019
Data monitoring committee
Yes
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CDX-011 and Capecitabine in people with Metastatic gpNMB Over-expressing Triple Negative Breast Cancer, run by Celldex Therapeutics at 140 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 140 sites in United States, Germany, Spain, France, Italy and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: Evaluated every 6 - 9 weeks following treatment initiation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01997333.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2019.

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