Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04489940
Recruitment Status : Recruiting
First Posted : July 28, 2020
Last Update Posted : April 30, 2021
Sponsor:
Collaborator:
Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
EMD Serono ( EMD Serono Research & Development Institute, Inc. )

Tracking Information
First Submitted Date  ICMJE July 27, 2020
First Posted Date  ICMJE July 28, 2020
Last Update Posted Date April 30, 2021
Actual Study Start Date  ICMJE October 12, 2020
Estimated Primary Completion Date February 23, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2020)
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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2020)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Concentration of Bintrafusp alfa at the end of Infusion (Ceoi) [ Time Frame: Time from first treatment to planned final assessment at approximately 2 years ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bintrafusp Alfa in High Mobility Group AT-Hook 2 (HMGA2) Expressing Triple Negative Breast Cancer
Official Title  ICMJE A Phase II, Multicenter, Open Label Study of Bintrafusp Alfa (M7824) Monotherapy in Participants With HMGA2-expressing Triple Negative Breast Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Triple Negative Breast Neoplasms
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Bintrafusp alfa
Intervention: Drug: Bintrafusp alfa
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 27, 2020)
29
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 23, 2023
Estimated Primary Completion Date February 23, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: US Medical Information 888-275-7376 eMediUSA@emdserono.com
Contact: Communication Center +49 6151 72 5200 service@emdgroup.com
Listed Location Countries  ICMJE Belgium,   France,   Italy,   Russian Federation,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04489940
Other Study ID Numbers  ICMJE MS200647_0020
2019-004833-18 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients 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 https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html
Responsible Party EMD Serono ( EMD Serono Research & Development Institute, Inc. )
Study Sponsor  ICMJE EMD Serono Research & Development Institute, Inc.
Collaborators  ICMJE Merck KGaA, Darmstadt, Germany
Investigators  ICMJE
Study Director: Medical Responsible Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
PRS Account EMD Serono
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP