Description:
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.
Title
- Brief Title: Bintrafusp Alfa in High Mobility Group AT-Hook 2 (HMGA2) Expressing Triple Negative Breast Cancer
- Official Title: A Phase II, Multicenter, Open Label Study of Bintrafusp Alfa (M7824) Monotherapy in Participants With HMGA2-expressing Triple Negative Breast Cancer
Clinical Trial IDs
- ORG STUDY ID:
MS200647_0020
- SECONDARY ID:
2019-004833-18
- NCT ID:
NCT04489940
Conditions
- Triple Negative Breast Neoplasms
Interventions
Drug | Synonyms | Arms |
---|
Bintrafusp alfa | M7824 | Bintrafusp alfa |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Bintrafusp alfa | Experimental | | |
Eligibility 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | 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) |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | 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 |
Safety Issue: | |
Description: | |
Measure: | 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 |
Safety Issue: | |
Description: | |
Measure: | 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 |
Safety Issue: | |
Description: | |
Measure: | 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 |
Safety Issue: | |
Description: | |
Measure: | 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 |
Safety Issue: | |
Description: | |
Measure: | 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 |
Safety Issue: | |
Description: | |
Measure: | 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 |
Safety Issue: | |
Description: | |
Measure: | 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 |
Safety Issue: | |
Description: | |
Measure: | 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 |
Safety Issue: | |
Description: | |
Measure: | Concentration of Bintrafusp alfa at the end of Infusion (Ceoi) |
Time Frame: | Time from first treatment to planned final assessment at approximately 2 years |
Safety Issue: | |
Description: | |
Measure: | 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 |
Safety Issue: | |
Description: | |
Measure: | 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 |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | EMD Serono Research & Development Institute, Inc. |
Trial Keywords
- M7824
- INTR@PID Breast 020
- Bintrafusp alfa
- Programmed death-ligand 1
- Transforming growth factor-β (TGF-β)
- Breast Cancer
- MS200647
Last Updated
April 30, 2021