Last updated 8 days ago
A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011)
1000 patients around the world
Available in Argentina, United States
Merck Sharp & Dohme LLC
1Research sites
1000Patients around the world
This study is for people with
Breast Cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
Instituto Médico de la Fundación Estudios Clínicos - Rosario
Recruiting
SponsorMerck Sharp & Dohme LLC
Study typeInterventional
Conditions
Breast Cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06841354
