A Randomized Multicenter Pivotal Study of CDX-011 (CR011-vcMMAE)in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer (The METRIC 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.
Phase
Phase 2/3 - for trials that are a combination of phases 2 and 3.Inclusion and Exclusion 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.
Sites
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California
- USC Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, 90033
- Clinical Trials and Research Associates, Montebello, California, 90640
- St. Jude Heritage Medical Group, Fullerton, California, 92835
- Wilshire Oncology Medical Group, La Verne, California, 91750
- Wilshire Oncology Medical Group, La Verne, California, 91750
- Hematology Oncology Medical Group of Orange Country, Inc., Orange, California, 92868
- Wellness Hematology Oncology, West Hills, California, 91307
- Coastal Interactive Cancer Care, San Luis Obispo, California, 93401
- Pacific Cancer Care, Salinas/Monterey, California, 93901
- University of California San Francisco, San Francisco, California, 94115
- University of California Davis Medical Center, Sacramento, California, 95817
- Kaiser Permaente, Vallejo, California, 94589
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Arizona
- Yuma Regional Cancer Center, Yuma, Arizona, 85364
- Arizona Center for Cancer Care, Glendale, Arizona, 85306
- Arizona Cancer Research Alliance, Scottsdale, Arizona, 85251
- Arizona Cancer Center, Tucson, Arizona, 85724
-
Oregon
- Bay Area Hospital, Coos Bay, Oregon, 97420
- Oregon Health and Science University, Beaverton, Oregon, 97006
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Montana
- Montana Cancer Specialists, Missoula, Montana, 59802
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Texas
- Texas Tech University Health Sciences Center, Lubbock, Texas, 79430
- Oncology Hematology Consultants PA, Forth Worth, Texas, 76104
- Baylor Collete of Medicine, Houston, Texas, 77030
- University of Texas Health Science Center at Houston, Houston, Texas, 77030
-
Washington
- Swedish Cancer Institute, Seattle, Washington, 98104
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Oklahoma
- Mercy Clinic of Oklahoma, Oklahoma City, Oklahoma, 73120
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Nebraska
- Missouri Valley Cancer Consortium, Omaha, Nebraska, 68106
-
Arkansas
- University of Arkansas for Medical Sciences, Little Rock, Arkansas, 72205
-
Missouri
- Columbia Comprehensive Cancer Care Clinic, Jefferson City, Missouri, 65109
- St John's Mercy Medical Center, St. Louis, Missouri, 63141
- Washington University Dept of Oncology, St. Louis, Missouri, 63110
- Washington University Dept of Oncology, St. Louis, Missouri, 63110
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Iowa
- Cedar Valley Medical Specialists, Waterloo, Iowa, 50701
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Tennessee
- The Jones Clinic, PC, Germantown, Tennessee, 38138
- Sarah Cannon Cancer Center, Nashville, Tennessee, 37203
- Chattanooga Oncology Hematology Associates, Chattanooga, Tennessee, 37404
- Associates in Oncology and Hematology, Chattanooga, Tennessee, 37421
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Louisiana
- Oschner Medical Center, New Orleans, Louisiana, 70121
- Hematology and Oncology Specialists, Marrero, Louisiana, 70072
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Mississippi
- North Mississippi Hematology and Oncology Associates, Tupelo, Mississippi, 38801
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Illinois
- Carle Cancer Center, Urbana, Illinois, 61801
- Midwestern Regional Medical Center, Zion, Illinois, 60099
- Orchard Healthcare Research Inc., Skokie, Illinois, 60077
- Ingalis Memorial Hospital, Harvey, Illinois, 60426
- Edward H. Kaplan and Associates, Skokie, Illinois, 60076
- University of Chicago, Chicago, Illinois, 60637
- Illinois CancerCare, Peoria, Illinois, 60615
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Alabama
- Southern Cancer Center, Mobile, Alabama, 36608
- University of South Alabama Cancer Research Insititute, Mobile, Alabama, 36604
- University of Alabama at Birmingham, Birmingham, Alabama, 35294
- Alabama Oncology, Birmingham, Alabama, 35211
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Ohio
- Signal Point Clinical Research Center, LLC, Middletown, Ohio, 45042
- Oncology Hematology Care, Cincinnati, Ohio, 45242
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Georgia
- Northwest Georgia Oncology Centers P.C., Marietta, Georgia, 30060
- Piedmont Cancer Institute, Atlanta, Georgia, 30318
- Winship Cancer Institute, Emory University, Atlanta, Georgia, 30322
- Georgia Cancer Specialists Clinic, Atlanta, Georgia, 30341
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