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Bintrafusp Alfa in High Mobility Group AT-Hook 2 (HMGA2) Expressing Triple Negative Breast Cancer

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ClinicalTrials.gov Identifier: NCT04489940
Recruitment Status : Completed
First Posted : July 28, 2020
Last Update Posted : July 14, 2022
Sponsor:
Collaborator:
Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
EMD Serono ( EMD Serono Research & Development Institute, Inc. )

Study Description
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Brief Summary:
The main purpose of this study is to evaluate bintrafusp alfa monotherapy in participants with triple negative breast cancer (TNBC) who express high levels of HMGA2 as determined by a centralized reverse transcriptase-polymerase chain reaction (RT-PCR) test.

Condition or disease Intervention/treatment Phase
Triple Negative Breast Neoplasms Drug: Bintrafusp alfa Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Multicenter, Open Label Study of Bintrafusp Alfa (M7824) Monotherapy in Participants With HMGA2-expressing Triple Negative Breast Cancer
Actual Study Start Date : October 12, 2020
Actual Primary Completion Date : January 27, 2022
Actual Study Completion Date : July 8, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Bintrafusp alfa Drug: Bintrafusp alfa
Participants will receive an intravenous infusion of 1200 milligrams (mg) bintrafusp alfa once every 2 weeks until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
Other Name: M7824


Outcome Measures
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Primary Outcome Measures :
  1. Confirmed Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by an Independent Review Committee [ Time Frame: From first administration of study intervention up to study end (assessed up to approximately 2 years) ]

Secondary Outcome Measures :
  1. Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by an Independent Review Committee (IRC) [ Time Frame: From first documentation of objective response to the date of first documentation of objective progression disease or death due to any cause, assessed up to approximately 2 years ]
  2. Durable Response of at Least 6 Months Assessed by an Independent Review Committee (IRC) [ Time Frame: From first documentation of objective response to the date of first documentation of objective progression disease or death due to any cause, assessed up to approximately 2 years ]
  3. Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by an Independent Review Committee (IRC) [ Time Frame: From first documentation of objective response to the date of first documentation of objective progression disease or death due to any cause, assessed up to approximately 2 years ]
  4. Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by the Investigator [ Time Frame: From first documentation of objective response to the date of first documentation of objective progression disease or death due to any cause, assessed up to approximately 2 years ]
  5. Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by the Investigator [ Time Frame: From first documentation of objective response to the date of first documentation of objective progression disease or death due to any cause, assessed up to approximately 2 years ]
  6. Durable Response Rate (DRR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator [ Time Frame: From first documentation of objective response to the date of first documentation of objective progression disease or death due to any cause, assessed up to approximately 2 years ]
  7. Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator [ Time Frame: From first documentation of objective response to the date of first documentation of objective progression disease or death due to any cause, assessed up to approximately 2 years ]
  8. Overall Survival (OS) [ Time Frame: From first administration of study intervention to the date of death due to any cause, assessed up to approximately 2 years ]
  9. Occurrence of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related AEs, Including Adverse Events of Special Interest (AESIs) [ Time Frame: From first dose to final assessment up to approximately 2 years ]
  10. Concentration of Bintrafusp alfa at the end of Infusion (Ceoi) [ Time Frame: Time from first treatment to planned final assessment at approximately 2 years ]
  11. Concentration of Bintrafusp alfa at the end of the Dosing Interval (C trough) [ Time Frame: Time from first treatment to planned final assessment at approximately 2 years ]
  12. Immunogenicity of Bintrafusp alfa as Measured by Anti-drug Antibodies Concentration [ Time Frame: Time from first administration of treatment intervention to planned final assessment at approximately 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Study participants have histologically or cytologically confirmed TNBC
  • 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)
  • Other protocol defined inclusion criteria could apply

Exclusion Criteria:

  • Participants with active central nervous system (CNS) metastases causing clinical symptoms or metastases that require therapeutic intervention are excluded. Participants with a history of treated CNS metastases (by surgery or radiation therapy) are not eligible unless they have fully recovered from treatment, demonstrated no progression for at least 4 weeks, and are not using steroids for at least 7 days prior to the start of study intervention
  • 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
  • Other protocol defined exclusion criteria could apply
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04489940


Locations
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Sponsors and Collaborators
EMD Serono Research & Development Institute, Inc.
Merck KGaA, Darmstadt, Germany
Investigators
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Study Director: Medical Responsible Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
More Information
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Additional Information:

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Responsible Party: EMD Serono Research & Development Institute, Inc.
ClinicalTrials.gov Identifier: NCT04489940    
Other Study ID Numbers: MS200647_0020
2019-004833-18 ( EudraCT Number )
First Posted: July 28, 2020    Key Record Dates
Last Update Posted: July 14, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
Access Criteria: Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.
URL: http://bit.ly/IPD21

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by EMD Serono ( EMD Serono Research & Development Institute, Inc. ):
M7824
Bintrafusp alfa
Programmed death-ligand 1
 Transforming growth factor-β (TGF-β)
Breast Cancer
MS200647
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
 Neoplasms
Breast Diseases
Skin Diseases