Clinical Trial

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

Recruiting Phase 3
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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.
Protocol Amendment History 3 changes
notable Trial sites expanded: 299 -> 303 locations 2026-06-23
notable Trial sites expanded: 293 -> 297 locations 2026-05-30
notable Trial sites expanded: 288 -> 292 locations 2026-05-16
Trial Details
NCT Number NCT06393374
Lead Sponsor Merck Sharp & Dohme LLC
Conditions Triple-Negative Breast Cancer
Enrollment 1,530 participants
Start Date 2024-06-24
Primary Completion 2030-12-16 (estimated)
Study Completion 2037-12-14 (estimated)
Updated on ClinicalTrials.gov 2026-08-07