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NCT06312176Recruiting

A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)

An Open-label, Randomized Phase 3 Study of MK-2870 as a Single Agent and in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer
Merck Sharp & Dohme LLCPhase 3ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Breast Neoplasms
Drug/Device/Intervention
Sacituzumab tirumotecan
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Merck Sharp & Dohme LLC
Location
Nyack,Haifa,Petah Tikva,Tainan, Israel,Taiwan,United States of America
Timeline & enrollment
Phase
Phase 3
Start date
Apr 14, 2024
End date
Apr 12, 2031
Enrollment
1200 participants
Primary outcome

Progression-Free Survival (PFS) ( sacituzumab tirumotecan versus treatment of physician's choice [TPC]; pembrolizumab + sacituzumab tirumotecan versus TPC)

Summary

The purpose of this study is to compare sacituzumab tirumotecan as a single agent, and in
 combination with pembrolizumab, versus Treatment of Physician's Choice (TPC) in participants
 with hormone receptor positive/human epidermal growth factor receptor-2 negative (HR+/HER2-)
 unresectable locally advanced, or metastatic, breast cancer.
 
 The primary hypotheses are that sacituzumab tirumotecan as a single agent and sacituzumab
 tirumotecan plus pembrolizumab are superior to TPC with respect to progression-free survival
 (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded
 independent central review (BICR) in all participants.

ICD-10 classifications
Malignant neoplasm of breastMalignant neoplasm of breastMalignant neoplasm: Breast, unspecifiedBenign neoplasm of breastMalignant neoplasm: Central portion of breast
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06312176
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06312176 through Pure Global AI's free database. This Phase 3 trial is sponsored by Merck Sharp & Dohme LLC and is currently Recruiting. The study focuses on Breast Neoplasms. Target enrollment is 1200 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.