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

Primary Purpose

Metastatic gpNMB Over-expressing Triple Negative Breast Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CDX-011
Capecitabine
Sponsored by
Celldex Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic gpNMB Over-expressing Triple Negative Breast Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alabama Oncology
  • University of Alabama at Birmingham
  • University of South Alabama Cancer Research Insititute
  • Arizona Cancer Research Alliance
  • Arizona Cancer Center
  • University of Arkansas for Medical Sciences
  • Compassionate Care Research Group
  • St. Jude Heritage Medical Group
  • USC Norris Comprehensive Cancer Center and Hospital
  • University of California Davis Medical Center
  • Pacific Cancer Care
  • University of California San Francisco
  • Kaiser Permaente
  • Wellness Hematology Oncology
  • University of Miami Miller School of Medicine
  • Florida Cancer Specialists South
  • Memorial Regional Hospital
  • Baptist Cancer Institute
  • Florida Cancer Specialists
  • Tallahassee Memorial HealthCare
  • Peachtree Hematology Oncology Consultants, PC
  • Winship Cancer Institute, Emory University
  • Georgia Cancer Specialists Clinic
  • Northwest Georgia Oncology Centers P.C.
  • Summit Cancer Care, PC-Savannah
  • University of Chicago
  • Ingalis Memorial Hospital
  • Illinois CancerCare
  • Orchard Healthcare Research Inc.
  • Carle Cancer Center
  • Lafayette General Medical Center
  • Hematology and Oncology Specialists
  • Louisiana State University Health New Orleans
  • Oschner Medical Center
  • Anne Arundel Medical Center
  • University of Maryland
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Frederick Memorial Hospital
  • Holy Cross Hospital
  • Virginia Piper Cancer Center
  • HCA Midwest Health
  • Washington University Dept of Oncology
  • St John's Mercy Medical Center
  • Hunterdon Regional Cancer Center
  • Hackensack University Medical Center
  • Clinical Research Alliance, Inc.
  • ProHEALTH Care Associates
  • Beth Isreal Medical Center
  • Weill Cornell Medical Center
  • Stony Brook University Medical Center
  • Novant Health
  • Duke University Medical Center
  • Oncology Hematology Care
  • Cleveland Clinic-Taussig Cancer Institute-R35
  • Signal Point Clinical Research Center, LLC
  • Mercy Clinic of Oklahoma
  • Oregon Health and Science University
  • St Mary Medical Center
  • Fox Chase Cancer Center
  • Guthrie Clinical Research
  • Charleston Hematology Oncology Associates (CHOA)
  • Chattanooga Oncology Hematology Associates
  • Center for Biomedical Research, LLC
  • Sarah Cannon Cancer Center
  • Oncology Hematology Consultants PA
  • Baylor College of Medicine
  • Houston Methodist Cancer Center
  • University of Texas Health Science Center at Houston
  • Texas Tech University Health Sciences Center
  • Swedish Cancer Institute
  • Seattle Cancer Care Alliance
  • St. Vincents Hospital Sydney
  • Macquarie University
  • The Tweed Hospital
  • Sydney Adventist Hospital
  • Townsville Hospital
  • Box Hill Hospital
  • Western Hospital
  • Joint Ludwig-Austin Dept of Medical Oncology
  • Epworth Health Care
  • GasthuisZusters Antwerpen
  • Grand Hopital de Charleroi asbl
  • UZ Leuven
  • Clinique Edith Cavell
  • Institute Jules Bordet
  • Algoma District Cancer Program Sault Area Hospital
  • Sunnybrook Health Sciences Centre Odette Cancer Center
  • St. MIchael's Hospital
  • Sir Mortimer B Davis Jewish General Hospital
  • Universite de Montreal-Hopital Du Sacre-Coeur De Montreal
  • Centre Antoine Lacassagne Centre Régional de Lutte Contre Le Cancer
  • Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes
  • Centre Jean Bernard Clinique Victor Hugo
  • Institut Sainte Catherine
  • Centre Oscar Lambret
  • Hôpital de La Croix Rousse
  • Centre Hospitalier de Mont de Marson - Hôpital Layné
  • Institut Curie
  • Hospices Civils de Lyon
  • Centre Hospitalier Prive Saint-Gregoire
  • Klinikum Essingen GmbH
  • Helios Klinikum Berlin Buch
  • Kliniken der Stadt Koeln gGmbH - Krankenhaus Holweide
  • Universitätsklinikum Düsseldorf
  • Universitätsklinikum Erlangen
  • Klinikum Frankfurt Höchst GmbH
  • Martin-Luther-Universität Halle-Wittenberg
  • Universität Des Saarlandes
  • Rotkreuzklinikum München
  • Universitätsklinikum Münster
  • Hämatologisch-Onkologische Schwerpunktpraxis
  • Istituto Scientifico romagnolo Per Lo Studio E La Cura Del Tumori IRST
  • Fondazione Policlinico Universitario A Gemelli
  • Azienda Ospedaliera Fatebenefratelli e Oftaimico
  • Istituto Nazionale Dei Tumori
  • Istituto Europeo Di Oncologia
  • Istituto Clinico Humanitas
  • Centro Di Riferimento Oncologico
  • Azienda Ospedaliera Universitaria Pisana
  • Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
  • Azienda Ospedaliera Citta della Salute e della Scienza de Torino
  • Hospital Universitario Central de Asturias
  • Hospital Universitari Germans Trias i Pujol
  • Corporacio Sanitaria Parc Tauli
  • Consorcio Hospitalario Provincial de Castellon
  • Hospital Universitario Ramon y Cajal
  • Hospital Regional Universitario de Malaga - Hospital General
  • Hospital Universitario Vall d'Hebron
  • Hospital Clinic de Barcelona
  • MD Anderson Cancer Center Madrid-Espana
  • Hospital Clinico San Carlos
  • Hospital Clinico Universitario de Valencia
  • Barts Health NHS Trust
  • Derriford Hospital
  • Royal Sussex County Hospital
  • Beatson West of Scotland Cancer Centre
  • Blackpool Victoria Hospital
  • University College London
  • Nottingham University Hospitals NHS Trust
  • Sarah Cannon Research Institute UK

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Capecitabine

Drug: CDX-011

Arm Description

Capecitabine will be administered on Days 1 through 14 of each 21 day cycle.

CDX-011 administered as an intravenous infusion on Day 1 of each 21 day cycle.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Overall Survival
Overall Survival (OS) is defined as the number of months from randomization to the date of death due to any cause.
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.
Pharmacokinetics (PK)
Concentration of the antibody drug conjugate (ADC), total antibody (TA) and free MMAE will be determined.

Full Information

First Posted
November 18, 2013
Last Updated
March 6, 2019
Sponsor
Celldex Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT01997333
Brief Title
Study of Glembatumumab Vedotin (CDX-011) in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer
Acronym
METRIC
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
November 30, 2017 (Actual)
Study Completion Date
August 7, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celldex Therapeutics

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic gpNMB Over-expressing Triple Negative Breast Cancer
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
327 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Capecitabine
Arm Type
Active Comparator
Arm Description
Capecitabine will be administered on Days 1 through 14 of each 21 day cycle.
Arm Title
Drug: CDX-011
Arm Type
Experimental
Arm Description
CDX-011 administered as an intravenous infusion on Day 1 of each 21 day cycle.
Intervention Type
Drug
Intervention Name(s)
CDX-011
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
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.
Time Frame
Evaluated every 6 - 9 weeks following treatment initiation
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
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.
Time Frame
Evaluated every 6 - 9 weeks following treatment initiation
Title
Duration of Response
Description
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.
Time Frame
Evaluated every 6 - 9 weeks following treatment initiation
Title
Overall Survival
Description
Overall Survival (OS) is defined as the number of months from randomization to the date of death due to any cause.
Time Frame
During treatment and 3 months from end of treatment through end of study or approximately up to 5 years.
Title
Adverse Events (AE)
Description
The percentage of patients experiencing one or more adverse events will be summarized by treatment arm, relationship to study drug, and severity.
Time Frame
Usually following at least 1 cycle of study treatment (1 dose of CDX-011 or capecitabine and until discontinuation of follow-up)
Title
Pharmacokinetics (PK)
Description
Concentration of the antibody drug conjugate (ADC), total antibody (TA) and free MMAE will be determined.
Time Frame
Following 1 dose of CDX-011.

10. Eligibility

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

12. IPD Sharing Statement

Learn more about this trial

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

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