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NCT06312176 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study of Breast Neoplasms, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 1,200
- Enrollment target
- 20
- Study locations
NCT06312176 is a Phase 3 study of Breast Neoplasms that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 1,200 participants, above the 557-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (115% higher). The trial reports 20 study locations across 10 states.
The verdict
NCT06312176, a Phase 3 study of Breast Neoplasms, is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,200 participants
- Enrollment target
- 20
- Study locations
Study 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 Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Capecitabine
- DRUG Paclitaxel
- DRUG Nab-paclitaxel
- DRUG Sacituzumab tirumotecan
Study Locations (20)
California
- Providence Medical Foundation-Oncology ( Site 0020) - Fullerton
- Moores Cancer Center ( Site 0059) - La Jolla
- Cancer and Blood Specialty Clinic ( Site 0001) - Los Alamitos
Colorado
- University of Colorado Anschutz Medical Campus ( Site 0061) - Aurora
- UCHealth Cherry Creek Medical Center ( Site 0094) - Denver
- University of Colorado Health - Highlands Ranch Hospital ( Site 0095) - Highlands Ranch
Florida
- AdventHealth Altamonte Springs ( Site 0021) - Altamonte Springs
- University of Florida College of Medicine ( Site 0063) - Gainesville
- Orlando Health Cancer Institute ( Site 0011) - Orlando
Arizona
- Ironwood Cancer & Research Centers ( Site 0066) - Chandler
- Banner MD Anderson Cancer Center-Oncology ( Site 0004) - Gilbert
Connecticut
- Yale Cancer Center ( Site 0060) - New Haven
- Stamford Hospital ( Site 0049) - Stamford
Illinois
- Rush University Medical Center ( Site 0079) - Chicago
- University of Chicago Medical Center ( Site 0067) - Chicago
Maryland
- Greenebaum Comprehensive Cancer Center ( Site 0036) - Baltimore
- Mercy Medical Center - Baltimore-Medical Oncology and Hematology ( Site 0028) - Baltimore
Georgia
- Archbold Memorial Hospital-Lewis Hall Singletary Oncology Center ( Site 0032) - Thomasville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,200 participants |
| Start Date | 2024-04-14 |
| Est. Completion | 2031-04-12 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06312176
The ClinicalTrials.gov registry entry for NCT06312176 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 1,200 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 557-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (115% higher). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Breast Neoplasms appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT06312176 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Colorado, Florida.
Frequently Asked Questions
What is clinical trial NCT06312176 about?
NCT06312176 is a clinical study titled "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)". 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 adv...
What is the current status of trial NCT06312176?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,200 participants. The study started on 2024-04-14. Estimated completion is 2031-04-12.
What conditions does trial NCT06312176 study?
This clinical trial studies the following conditions: Breast Neoplasms.
What interventions are being tested in trial NCT06312176?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Capecitabine (DRUG), Paclitaxel (DRUG), Nab-paclitaxel (DRUG), Sacituzumab tirumotecan (DRUG).
Who is sponsoring clinical trial NCT06312176?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06312176 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.