NCT06393374

Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)

A Phase 3, Randomized, Open-label, Study to Compare the Efficacy and Safety of Adjuvant MK-2870 in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice (TPC) in Participants With Triple-Negative Breast Cancer (TNBC) Who Received Neoadjuvant Therapy and Did Not Achieve a Pathological Complete Response (pCR) at Surgery

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,530 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, open-label study comparing the efficacy and safety of adjuvant sacituzumab tirumotecan (MK-2870) in combination with pembrolizumab compared to treatment of physician's choice (TPC) in participants with triple-negative breast cancer (TNBC) who received neoadjuvant therapy and did not achieve a pathological complete response (pCR) at surgery. The primary objective is to compare sacituzumab tirumotecan plus pembrolizumab to TPC (pembrolizumab or pembrolizumab plus capecitabine) with respect to invasive disease-free survival (iDFS) per investigator assessment. It is hypothesized that sacituzumab tirumotecan plus pembrolizumab is superior to TPC with respect to iDFS per investigator assessment.

Conditions

• Triple-Negative Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab	Pembrolizumab 400 mg intravenous (IV) infusion q6w
BIOLOGICAL	Sacituzumab tirumotecan	Sacituzumab tirumotecan 4 mg/kg IV infusion q2w
DRUG	Capecitabine	Capecitabine 1000 mg/m\^2 to 1250 mg/m\^2 by mouth BID

Timeline

• Start date: 2024-06-24
• Primary completion: 2030-12-16
• Completion: 2037-12-14
• First posted: 2024-05-01
• Last updated: 2026-04-13

Locations

286 sites across 31 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Czechia, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Norway, Poland, Portugal, Singapore, South Korea, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study