Bintrafusp Alfa in High Mobility Group AT-Hook 2 (HMGA2) Expressing Triple Negative Breast Cancer
NCT ID: NCT04489940
Last Updated: 2023-04-10
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
11 participants
INTERVENTIONAL
2020-10-12
2022-07-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Bintrafusp alfa
Bintrafusp alfa
Participants received an intravenous infusion of 1200 milligrams (mg) bintrafusp alfa once every 2 weeks until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
Interventions
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Bintrafusp alfa
Participants received an intravenous infusion of 1200 milligrams (mg) bintrafusp alfa once every 2 weeks until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Absence of human epidermal growth factor receptor 2 (HER2), estrogen receptor, and progesterone receptor expression must be documented (criteria for defining TNBC are outlined in the protocol)
* Participants must have received at least one line of systemic therapy for metastatic disease and have progressed on the line of therapy immediately prior to study entry. There is no limit to the number of prior therapies
* Participants may prescreen for HMGA2 expression while on preceding treatment, however screening should only occur if in the opinion of the Investigator, the participant would likely be eligible for study within 6 months
* Participants must have measurable disease
* Availability of either archival tumor tissue or fresh core or excisional biopsy of a tumor lesion (primary or metastatic, excluding bone biopsies) is mandatory to determine HMGA2 expression level prior to enrollment
* HMGA2 high tumor expression is required and will be determined by a central lab
* Participants who have Eastern Cooperative Oncology Group (ECOG) PS of 0 to 1
* Participants have a life expectancy greater than or equal to (\>=) 12 weeks as judged by the Investigator at study start
* Participants have adequate hematological, hepatic and renal and coagulation function as defined in the protocol
* Participants with known Human Immunodeficiency Virus (HIV) infections are in general eligible if the criteria as defined in the protocol are met (Food and Drug Administration \[FDA\] Guidance on Cancer Clinical Trial Eligibility, March 2019)
* Participants with hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infections are in general eligible if the criteria as defined in the protocol are met (FDA Guidance on Cancer Clinical Trial Eligibility, March 2019)
Exclusion Criteria
* Participants must not have received prior cancer treatment with any other immunotherapy or checkpoint inhibitors, or any other immune-modulating monoclonal antibody
* Participants that received any organ transplantation, including stem-cell transplantation, but with the exception of transplants that do not require immunosuppression
* Participants with significant acute or chronic infections
* Participants with active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
* Participants with clinically significant cardiovascular/cerebrovascular disease including: cerebral vascular accident/stroke, myocardial infarction, unstable angina, congestive heart failure, or serious cardiac arrhythmia
18 Years
ALL
No
Sponsors
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Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
INDUSTRY
EMD Serono Research & Development Institute, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Locations
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Medical Oncology Hematology Consultants, PA, Helen F. Graham Cancer Center, Suite 3400
Newark, Delaware, United States
Mayo Clinic-Jacksonville
Jacksonville, Florida, United States
Maryland Oncology Hematology, P.A.
Silver Spring, Maryland, United States
New York Oncology Hematology, P.C. - Albany
Albany, New York, United States
TheOhio State University, Stefanie Spielman Comprehensive Breast Center
Columbus, Ohio, United States
UPMC Hillman Cancer Center - Hillman Cancer Center
Monroeville, Pennsylvania, United States
Charleston Hematology Oncology Associates, PA
Charleston, South Carolina, United States
The West Clinic
Germantown, Tennessee, United States
Texas Oncology, P.A. - Austin - Austin Central Cancer Center
Austin, Texas, United States
Texas Oncology, P.A. - Medical City Dallas - Pediatric Hematology/Oncology
Dallas, Texas, United States
Texas Oncology, P.A. - Plano
Plano, Texas, United States
Texas Oncology-San Antonio Stone Oak
San Antonio, Texas, United States
Texas Oncology, P.A. - Tyler
Tyler, Texas, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Virginia Oncology Associates - Hampton
Norfolk, Virginia, United States
Universitair Ziekenhuis Brussel - Geriatrie
Brussels, , Belgium
UZ Leuven
Leuven, , Belgium
AZ Sint-Maarten - PARENT
Mechelen, , Belgium
Centre François Baclesse - Pathologies Gynecologiques
Caen, , France
Centre Léon Bérard
Lyon, , France
Hôpital Privé du Confluent SAS
Nantes, , France
Groupe Hospitalier Diaconesses - Hôpital De La Croix Saint Simon - service d'oncologie medicale
Paris, , France
CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie
Plérin, , France
Institut Curie - Centre René Huguenin - Service d'Oncologie Médicale
Saint-Cloud, , France
IEO Istituto Europeo di Oncologia
Milan, , Italy
Ospedale San Raffaele
Milan, , Italy
Istituto Nazionale Tumori Fondazione G. Pascale - Dipartimento di Senologia
Napoli, , Italy
IOV - Istituto Oncologico Veneto IRCCS - Oncologia Medica 2
Padua, , Italy
Azienda Ospedaliero Universitaria Pisana - U.O. Oncologia II
Pisa, , Italy
Policlinico Universitario Agostino Gemelli - UOC Oncologia Medica
Roma, , Italy
Istituto Clinico Humanitas
Rozzano, , Italy
SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary" - Chemotherapy
Arkhangelsk, , Russia
SBIH " Clinical Oncological Dispensary # 1" - Location
Krasnodar, , Russia
SBIH " Clinical Oncological Dispensary 1" - Location
Krasnodar, , Russia
FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin" - Moscow Cancer Research Centre
Moscow, , Russia
BHI of Omsk region "Clinical Oncology Dispensary"
Omsk, , Russia
LLC "ClinicaUZI4D"
Pyatigorsk, , Russia
FSBI "Clinical Research and Practical Center for specialized medical care (oncology)"
Saint Petersburg, , Russia
Tomsk Research Instutite of Oncology - Chemotherapy
Tomsk, , Russia
SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan
Ufa, , Russia
Hospital Universitario Reina Sofia - Dept of Oncology
Córdoba, , Spain
Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica
Madrid, , Spain
Hospital Ruber Internacional - Servicio de Oncologia
Madrid, , Spain
Hospital Universitario Ramon y Cajal - Servicio de Oncologia
Madrid, , Spain
Hospital Universitario Virgen del Rocio - Servicio de Oncologia
Seville, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Trial Awareness and Transparency website
US Medical Information website, Medical Resources
Other Identifiers
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2019-004833-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MS200647_0020
Identifier Type: -
Identifier Source: org_study_id
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