Triple Negative Breast Cancer MedDRA version: 20.0 Level: PT Classification code 10075566 Term: Triple negative breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: bintrafusp alfa
Product Code: M7824
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: bintrafusp alfa
Current Sponsor code: M7824
Other descriptive name: MS
Sponsors
Merck Healthcare KGaA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Study participants are = 18 years of age at the time of signing the informed consent. 2. Study participants have histologically or cytologically confirmed TNBC. • Absence of 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. 3. Participants must have measurable disease. 4. 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. 5. HMGA2 high tumor expression is required and will be determined by a central lab. 6. Participants who have Eastern Cooperative Oncology Group (ECOG) PS of 0 to 1. 7. Participants have a life expectancy = 12 weeks as judged by the Investigator at study start. 8. Participants have adequate hematological, hepatic and renal and coagulation function as defined in the protocol. 9. Participants with known HIV infections are in general eligible if the criteria as defined in the protocol are met (FDA Guidance on Cancer Clinical Trial Eligibility, March 2019). 10. 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 26 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
Exclusion criteria: 1. 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. 2. Participants with interstitial lung disease or has had a history of pneumonitis that has required oral or intravenous (IV) steroids 3. Participants must not have received prior cancer treatment with any other immunotherapy or checkpoint inhibitors, or any other immune-modulating monoclonal antibody. 4. Participants that received any organ transplantation, including stem-cell transplantation, but with the exception of transplants that do not require immunosuppression. 5. Participants with significant acute or chronic infections. 6. Participants with active autoimmune disease that might deteriorate when receiving an immunostimulatory agent. 7. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate clinical efficacy of bintrafusp alfa in participants with TNBC with high HMGA2 expression, based on ORR;Primary end point(s): Confirmed objective response according to RECIST 1.1 assessed by an IRC;Timepoint(s) of evaluation of this end point: from first administration of study intervention up to study end;Secondary Objective: To evaluate clinical efficacy of bintrafusp alfa based on DOR To evaluate clinical efficacy of bintrafusp alfa based on DRR To evaluate clinical efficacy based on PFS To evaluate ORR, DOR, DRR, and PFS by Investigator read To evaluate clinical efficacy based on OS To evaluate clinical safety of bintrafusp alfa To characterize the PK profile of bintrafusp alfa To characterize the immunogenicity of bintrafusp alfa | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.DOR according to RECIST 1.1 assessed by an IRC 2.Durable response of at least 6 months assessed by an IRC 3.PFS according to RECIST 1.1 assessed by an IRC 4.Objective response, DOR, DRR, and PFS according to RECIST 1.1 as assessed by the Investigator 5.OS 6.Occurrence of TEAEs and treatment-related AEs including AEs of special interest 7.PK (pharmacokinetic) parameters for bintrafusp alfa 8.Immunogenicity of bintrafusp alfa as measured by ADA assay ;Timepoint(s) of evaluation of this end point: 1-2-3-4.from first documentation of objective response to the date of first documentation of objective PD or death due to any cause 5.from first administration of study intervention to the date of death due to any cause 6.from first dose to final assessment up to approximately 2 years 7.From first assessment up to 28 days after last treatment 8.Time from first administration of treatment intervention to planned final assessment at approximately 2 years. | — |
Countries
Belgium, France, Italy, Russian Federation, Spain, United States
Contacts
Public ContactCommunication Center Merck KGaA
Merck Healthcare KGaA
Outcome results
None listed