Trials / Recruiting
RecruitingNCT06312176
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
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,200 (estimated)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sacituzumab tirumotecan | IV infusion |
| BIOLOGICAL | Pembrolizumab | IV infusion |
| DRUG | Paclitaxel | IV infusion |
| DRUG | Nab-paclitaxel | IV infusion |
| DRUG | Capecitabine | oral tablet |
| DRUG | Liposomal doxorubicin | IV infusion |
Timeline
- Start date
- 2024-04-14
- Primary completion
- 2027-07-11
- Completion
- 2031-04-12
- First posted
- 2024-03-15
- Last updated
- 2026-04-02
Locations
258 sites across 40 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Czechia, Denmark, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06312176. Inclusion in this directory is not an endorsement.