Triple-Negative Breast Cancer
Conditions
Interventions
Arm A : MK-2870
Participants receive MK-2870 intravenously (IV) at a dose of 4 mg/kg every 2 weeks (Q2W) until one of the criteria for discontinuation are met. Additionally, participants may receive r
Sponsors
Fujita Tomoko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Has locally recurrent unresectable or metastatic TNBC that cannot be treated with curative intent - Has not received systemic treatment for locally recurrent unresectable or metastatic TNBC - Participants previously treated for early-stage breast cancer must have completed all prior therapy for early-stage breast cancer with curative intent at least 6 months before the first disease recurrence - Is a candidate for treatment with one of the TPC options: paclitaxel or nab-paclitaxel or gemcitabine + carboplatin - Participants who have AEs due to previous anticancer therapies must have recovered to <=Grade 1 or baseline with the exception of alopecia or vitiligo. Participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible - Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load - Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
Exclusion criteria
Exclusion criteria: - Has breast cancer amenable to treatment with curative intent - Has TNBC with evaluable tumor programmed death ligand 1 (PD-L1) expression at combined positive score (CPS) >=10 - Has received prior systemic therapy for treatment of locally recurrent unresectable or metastatic TNBC - Has Grade >=2 peripheral neuropathy - Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing - Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease - Has uncontrolled, significant cardiovascular disease or cerebrovascular disease - Has skin only metastatic disease - Has advanced/metastatic, symptomatic visceral spread at risk of rapidly evolving into life-threatening complications - Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease - Has known additional malignancy that is progressing or has required active treatment within the past 5 years - Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable - Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed - History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease - Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV deoxyribonucleic acid (DNA)) and Hepatitis C virus (HCV) (defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA)) infection - History of stem cell/solid organ transplant - Has not adequately recovered from major surgery or has ongoing surgical complications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - To compare MK-2870 to TPC with respect to progression-free survival (PFS) - To compare MK-2870 plus MK-3475 to TPC with respect to PFS - To compare MK-2870 to TPC with respect to overall survival (OS) | — |
Secondary
| Measure | Time frame |
|---|---|
| - To compare MK-2870 plus MK-3475 to TPC with respect to OS - To compare MK-2870 plus MK-3475 to MK-2870 with respect to PFS - To compare MK-2870 to TPC with respect to objective response rate (ORR) - To compare MK-2870 plus MK-3475 to TPC with respect to ORR - duration of response - health-related quality of life - safety and tolerability | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Peru, Philippines, Poland, Refer to 7-5, Romania, South Korea, Spain, Taiwan, Thailand
Contacts
Public ContactMSDJRCT inquiry mailbox
MSD K.K.
Outcome results
None listed