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

NCT01997333 | Completed Phase 2 Results DMC

• 1 other identifier: CDX011-04
• Study Type: interventional
• Target: 327
• Locations: 9 countries
• Sites: 140

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.

Conditions

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

Outcome Measures

Primary Outcomes (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.

  Evaluated every 6 - 9 weeks following treatment initiation

Secondary Outcomes (5)

• Objective Response Rate (ORR)

  Evaluated every 6 - 9 weeks following treatment initiation

• Duration of Response

  Evaluated every 6 - 9 weeks following treatment initiation

• Overall Survival

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

• Adverse Events (AE)

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

• Pharmacokinetics (PK)

  Following 1 dose of CDX-011.

Study Arms (2)

Capecitabine

ACTIVE COMPARATOR

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

Drug: Capecitabine

Drug: CDX-011

EXPERIMENTAL

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

Drug: CDX-011

Interventions

CDX-011 DRUG

Drug: CDX-011

Capecitabine DRUG

Capecitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Chronic use of systemic corticosteroids.

Sponsors & Collaborators

• Celldex Therapeutics: lead

Study Sites (140)

Alabama Oncology

Birmingham, Alabama, 35211, United States

Location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of South Alabama Cancer Research Insititute

Mobile, Alabama, 36604, United States

Location

Arizona Cancer Research Alliance

Glendale, Arizona, 85304, United States

Location

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Compassionate Care Research Group

Fountain Valley, California, 92708, United States

Location

St. Jude Heritage Medical Group

Fullerton, California, 92835, United States

Location

USC Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90033, United States

Location

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

Pacific Cancer Care

Salinas, California, 93901, United States

Location

University of California San Francisco

San Francisco, California, 94115, United States

Location

Kaiser Permaente

Vallejo, California, 94589, United States

Location

Wellness Hematology Oncology

West Hills, California, 91307, United States

Location

University of Miami Miller School of Medicine

Deerfield Beach, Florida, 33442, United States

Location

Florida Cancer Specialists South

Fort Myers, Florida, 33916, United States

Location

Memorial Regional Hospital

Hollywood, Florida, 33021, United States

Location

Baptist Cancer Institute

Jacksonville, Florida, 32207, United States

Location

Florida Cancer Specialists

New Port Richey, Florida, 34655, United States

Location

Tallahassee Memorial HealthCare

Tallahassee, Florida, 32308, United States

Location

Peachtree Hematology Oncology Consultants, PC

Atlanta, Georgia, 30318, United States

Location

Winship Cancer Institute, Emory University

Atlanta, Georgia, 30322, United States

Location

Georgia Cancer Specialists Clinic

Atlanta, Georgia, 30341, United States

Location

Northwest Georgia Oncology Centers P.C.

Marietta, Georgia, 30060, United States

Location

Summit Cancer Care, PC-Savannah

Savannah, Georgia, 31405, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Ingalis Memorial Hospital

Harvey, Illinois, 60426, United States

Location

Illinois CancerCare

Peoria, Illinois, 60615, United States

Location

Orchard Healthcare Research Inc.

Skokie, Illinois, 60077, United States

Location

Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Lafayette General Medical Center

Lafayette, Louisiana, 70503, United States

Location

Hematology and Oncology Specialists

Marrero, Louisiana, 70072, United States

Location

Louisiana State University Health New Orleans

New Orleans, Louisiana, 70112, United States

Location

Oschner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Anne Arundel Medical Center

Annapolis, Maryland, 21401, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21287-0013, United States

Location

Frederick Memorial Hospital

Frederick, Maryland, 21701, United States

Location

Holy Cross Hospital

Silver Spring, Maryland, 20902, United States

Location

Virginia Piper Cancer Center

Minneapolis, Minnesota, 55407, United States

Location

HCA Midwest Health

Kansas City, Missouri, 64132, United States

Location

Washington University Dept of Oncology

St Louis, Missouri, 63110, United States

Location

St John's Mercy Medical Center

St Louis, Missouri, 63141, United States

Location

Hunterdon Regional Cancer Center

Flemington, New Jersey, 08822, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Clinical Research Alliance, Inc.

Lake Success, New York, 11042, United States

Location

ProHEALTH Care Associates

Lake Success, New York, 11042, United States

Location

Beth Isreal Medical Center

New York, New York, 10011, United States

Location

Weill Cornell Medical Center

New York, New York, 10021, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

Novant Health

Charlotte, North Carolina, 28204, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Oncology Hematology Care

Cincinnati, Ohio, 45242, United States

Location

Cleveland Clinic-Taussig Cancer Institute-R35

Cleveland, Ohio, 44195, United States

Location

Signal Point Clinical Research Center, LLC

Middletown, Ohio, 45042, United States

Location

Mercy Clinic of Oklahoma

Oklahoma City, Oklahoma, 73120, United States

Location

Oregon Health and Science University

Beaverton, Oregon, 97006, United States

Location

St Mary Medical Center

Langhorne, Pennsylvania, 19047, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Guthrie Clinical Research

Sayre, Pennsylvania, 18840, United States

Location

Charleston Hematology Oncology Associates (CHOA)

Charleston, South Carolina, 29414, United States

Location

Chattanooga Oncology Hematology Associates

Chattanooga, Tennessee, 37404, United States

Location

Center for Biomedical Research, LLC

Knoxville, Tennessee, 37909, United States

Location

Sarah Cannon Cancer Center

Nashville, Tennessee, 37203, United States

Location

Oncology Hematology Consultants PA

Fort Worth, Texas, 76104, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Houston Methodist Cancer Center

Houston, Texas, 77030, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

St. Vincents Hospital Sydney

Darlinghurst, New South Wales, 2010, Australia

Location

Macquarie University

Macquarie Park, New South Wales, 2109, Australia

Location

The Tweed Hospital

Tweed Heads, New South Wales, 2485, Australia

Location

Sydney Adventist Hospital

Wahroonga, New South Wales, 2076, Australia

Location

Townsville Hospital

Douglas, Queensland, 4814, Australia

Location

Box Hill Hospital

Box Hill, Victoria, 3128, Australia

Location

Western Hospital

Footscray, Victoria, 3011, Australia

Location

Joint Ludwig-Austin Dept of Medical Oncology

Heidelberg, Victoria, 3084, Australia

Location

Epworth Health Care

Richmond, Victoria, 3121, Australia

Location

GasthuisZusters Antwerpen

Wilrijk, Antwerpen, 2610, Belgium

Location

Grand Hopital de Charleroi asbl

Charleroi, Hainaut, 6000, Belgium

Location

UZ Leuven

Leuven, Vlaams Brabant, 3000, Belgium

Location

Institute Jules Bordet

Brussels, 1000, Belgium

Location

Clinique Edith Cavell

Brussels Capital Region, 1180, Belgium

Location

Algoma District Cancer Program Sault Area Hospital

Sault Ste. Marie, Ontario, P6B-0A8, Canada

Location

Sunnybrook Health Sciences Centre Odette Cancer Center

Toronto, Ontario, M4N 3M5, Canada

Location

St. MIchael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Sir Mortimer B Davis Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Universite de Montreal-Hopital Du Sacre-Coeur De Montreal

Montreal, Quebec, H4J 1C5, Canada

Location

Centre Antoine Lacassagne Centre Régional de Lutte Contre Le Cancer

Nice, Alpes-Maritimes, 06189, France

Location

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

Lyon, Rhône, 69373, France

Location

Centre Jean Bernard Clinique Victor Hugo

Le Mans, Sarthe, 72000, France

Location

Institut Sainte Catherine

Avignon, 84000, France

Location

Centre Oscar Lambret

Lille, 59000, France

Location

Hôpital de La Croix Rousse

Lyon, 69317, France

Location

Centre Hospitalier de Mont de Marson - Hôpital Layné

Mont-de-Marsan, 40000, France

Location

Institut Curie

Paris, 75005, France

Location

Hospices Civils de Lyon

Pierre-Bénite, 69495, France

Location

Centre Hospitalier Prive Saint-Gregoire

Saint-Grégoire, 35768, France

Location

Klinikum Essingen GmbH

Esslingen am Neckar, Baden-Wurttemberg, 73730, Germany

Location

Helios Klinikum Berlin Buch

Berlin, 13125, Germany

Location

Kliniken der Stadt Koeln gGmbH - Krankenhaus Holweide

Cologne, 51067, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, 40225, Germany

Location

Universitätsklinikum Erlangen

Erlangen, 91054, Germany

Location

Klinikum Frankfurt Höchst GmbH

Frankfurt am Main, 65929, Germany

Location

Martin-Luther-Universität Halle-Wittenberg

Halle, 06120, Germany

Location

Universität Des Saarlandes

Homberg (Efze), 66421, Germany

Location

Rotkreuzklinikum München

Munich, 80637, Germany

Location

Universitätsklinikum Münster

Münster, 48149, Germany

Location

Hämatologisch-Onkologische Schwerpunktpraxis

Troisdorf, 53840, Germany

Location

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

Meldola, Emilia-Romagna, 47014, Italy

Location

Fondazione Policlinico Universitario A Gemelli

Rome, Lazio, 00168, Italy

Location

Azienda Ospedaliera Fatebenefratelli e Oftaimico

Milan, Lombardy, 20121, Italy

Location

Istituto Nazionale Dei Tumori

Milan, Lombardy, 20133, Italy

Location

Istituto Europeo Di Oncologia

Milan, Lombardy, 20141, Italy

Location

Istituto Clinico Humanitas

Rozzano, Lombardy, 20089, Italy

Location

Centro Di Riferimento Oncologico

Aviano, Pordenone, 33081, Italy

Location

Azienda Ospedaliera Universitaria Pisana

Pisa, Tuscany, 56126, Italy

Location

Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi

Bologna, 40138, Italy

Location

Azienda Ospedaliera Citta della Salute e della Scienza de Torino

Torino, 10126, Italy

Location

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Corporacio Sanitaria Parc Tauli

Sabadell, Barcelona, 08208, Spain

Location

Consorcio Hospitalario Provincial de Castellon

Castellon, Castellón, 12002, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, Communidad Delaware, 28034, Spain

Location

Hospital Regional Universitario de Malaga - Hospital General

Málaga, Málaga, 29011, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

MD Anderson Cancer Center Madrid-Espana

Madrid, 28033, Spain

Location

Hospital Clinico San Carlos

Madrid, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

Barts Health NHS Trust

London, City of London, EC1A 7BE, United Kingdom

Location

Derriford Hospital

Plymouth, Devon, PL6 8DH, United Kingdom

Location

Royal Sussex County Hospital

Brighton, East Sussex, BN2 5BE, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, Glasgow City, G12 0YN, United Kingdom

Location

Blackpool Victoria Hospital

Blackpool, Lancashire, FY3 8NR, United Kingdom

Location

University College London

London, London, City of, NW1 2PG, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Location

Sarah Cannon Research Institute UK

City of London, W1G 6AD, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

glembatumumab vedotin; Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Head of Regulatory Affairs
• Organization: Celldex Therapeutics

info@celldex.com

844-723-9363

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: November 18, 2013
• First Posted: November 28, 2013
• Study Start: November 1, 2013
• Primary Completion: November 30, 2017
• Study Completion: August 7, 2018
• Last Updated: March 8, 2019
• Results First Posted: March 8, 2019

Record last verified: 2019-03

Locations

CA (5); IT (10); DE (11); ES (11); US (71); GB (8); BE (5); AU (9); FR (10)