Recruiting

Phase 3

Sacituzumab Tirutecan & PembrolizumabA 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)

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT06312176

Conditions

Breast Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sacituzumab tirumotecan

Pembrolizumab

Paclitaxel

Nab-paclitaxel

Capecitabine

Study Details

Brief 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

Breast Neoplasms

Study ID

NCT06312176

Start date

Apr 14, 2024

Status verified date

Sep, 2026

Completion date

Apr 12, 2031

Anticipated

Primary completion date

Jul 11, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Has unresectable locally advanced or metastatic centrally-confirmed hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer
Has radiographic disease progression on one or more lines of endocrine therapy for unresectable locally advanced/metastatic HR+/HER2- breast cancer, with one in combination with a CDK4/6 inhibitor
Is a chemotherapy candidate
Has an eastern cooperative oncology group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization
Has adequate organ function
Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

Exclusion Criteria:

Has breast cancer amenable to treatment with curative intent
Has experienced an early recurrence (<6 months after completing adjuvant/neoadjuvant chemotherapy) and therefore is eligible to receive second-line (2L) treatment
Has symptomatic advanced/metastatic visceral spread at risk of rapidly evolving into life-threatening complications
Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer
Active autoimmune disease that has required systemic treatment in the past 2 years
History of (noninfectious) pneumonitis/interstitial lung disease that requires steroids, or has current pneumonitis/interstitial lung disease
Has an active infection requiring systemic therapy

Study Design

Enrollment

1200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A: Sacituzumab tirumotecan

Participants receive 4 mg/kg of sacituzumab tirumotecan once every 2 weeks (Q2W) via intravenous (IV) infusion until progressive disease or discontinuation.

experimental: Arm B:Pembrolizumab + Sacituzumab tirumotecan

Participants receive 4 mg/kg of sacituzumab tirumotecan Q2W via IV infusion until progressive disease or discontinuation PLUS 400 mg of pembrolizumab once every 6 weeks (Q6W) via IV infusion for up to 18 administrations (up to \~2 years).

active comparator: Arm C: Treatment of Physician's Choice (TPC)

At the physician's discretion, participants receive chemotherapy of 80 mg/m\^2 of paclitaxel once every week (Q1W) via IV infusion OR 90 mg/m\^2 of paclitaxel once every 4 weeks (Q4W) via IV infusion OR 100 mg/m\^2 of nab-paclitaxel Q4W via IV infusion OR 1000 mg/m\^2 of capecitabine every 3 weeks (Q3W) orally OR 50 mg/m\^2 of liposomal doxorubicin once every 4 weeks (Q4W) via IV infusion, until progressive disease or discontinuation.

Interventions

Sacituzumab tirumotecan

IV infusion

Pembrolizumab

IV infusion

Paclitaxel

IV infusion

Nab-paclitaxel

IV infusion

Capecitabine

oral tablet

Liposomal doxorubicin

IV infusion

Primary outcome measure

Progression-Free Survival (PFS) ( sacituzumab tirumotecan versus treatment of physician's choice [TPC]; pembrolizumab + sacituzumab tirumotecan versus TPC) [ Time Frame: Up to ~38 months ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839 Trialsites@msd.com

Locations

Ironwood Cancer & Research Centers ( Site 0066)

Recruiting

Chandler, Arizona, United States, 85224

Contacts

Study Coordinator

480-821-2838

Banner MD Anderson Cancer Center-Oncology ( Site 0004)

Recruiting

Gilbert, Arizona, United States, 85234

Contacts

Study Coordinator

480-256-6444

Providence Medical Foundation-Oncology ( Site 0020)

Recruiting

Fullerton, California, United States, 92835

Contacts

Study Coordinator

714-446-5900

Cancer and Blood Specialty Clinic ( Site 0001)

Recruiting

Los Alamitos, California, United States, 90720

Contacts

Study Coordinator

562-353-1200

University of Colorado Anschutz Medical Campus ( Site 0061)

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Study Coordinator

303-724-6077

UCHealth Cherry Creek Medical Center ( Site 0094)

Recruiting

Denver, Colorado, United States, 80206

Contacts

Study Coordinator

720-848-1030

Yale Cancer Center ( Site 0060)

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Study Coordinator

203-688-4242

Stamford Hospital ( Site 0049)

Recruiting

Stamford, Connecticut, United States, 06902

Contacts

Study Coordinator

203-276-1000

AdventHealth Altamonte Springs ( Site 0021)

Recruiting

Altamonte Springs, Florida, United States, 32701

Contacts

Study Coordinator

407-834-5151

Orlando Health Cancer Institute ( Site 0011)

Recruiting

Orlando, Florida, United States, 32806

Contacts

Study Coordinator

321-843-8370

Archbold Memorial Hospital-Lewis Hall Singletary Oncology Center ( Site 0032)

Recruiting

Thomasville, Georgia, United States, 31792

Contacts

Study Coordinator

229-584-5400

Rush University Medical Center ( Site 0079)

Recruiting

Chicago, Illinois, United States, 60607

Contacts

Study Coordinator

312-942-3498

University of Chicago Medical Center ( Site 0067)

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Study Coordinator

773-702-6149

Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0053)

Recruiting

Edgewood, Kentucky, United States, 41017

Contacts

Study Coordinator

859-301-4245

Mary Bird Perkins Cancer Center-Breast & GYN Pavilion ( Site 0042)

Recruiting

Baton Rouge, Louisiana, United States, 70817

Contacts

Study Coordinator

888-501-4763

Greenebaum Comprehensive Cancer Center ( Site 0036)

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Study Coordinator

410-328-6373

Holy Cross Hospital ( Site 0073)

Recruiting

Silver Spring, Maryland, United States, 20910

Contacts

Study Coordinator

301-754-7000

Dana-Farber Cancer Institute-Breast Oncology Center ( Site 0037)

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Study Coordinator

857-215-3246

Henry Ford Health ( Site 0002)

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Study Coordinator

313-916-2576

Saint Luke's Cancer Institute ( Site 0027)

Recruiting

Kansas City, Missouri, United States, 64111

Contacts

Study Coordinator

816-932-2677

Washington University School of Medicine ( Site 0076)

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Study Coordinator

314-454-8313

NYU Langone Health - Brooklyn ( Site 0089)

Recruiting

Brooklyn, New York, United States, 11220

Contacts

Study Coordinator

212-731-6000

NYU Langone Hospital - Long Island ( Site 0090)

Recruiting

Mineola, New York, United States, 11501

Contacts

Study Coordinator

212-731-6000

Laura and Isaac Perlmutter Cancer Center-Hematology and Oncology ( Site 0068)

Recruiting

New York, New York, United States, 10016

Contacts

Study Coordinator

212-731-6000

Hematology Oncology Associates of Rockland ( Site 0054)

Recruiting

Nyack, New York, United States, 10960

Contacts

Study Coordinator

845-362-1750

Stony Brook University-Cancer Center ( Site 0034)

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Study Coordinator

631-444-4392

Levine Cancer Institute ( Site 0014)

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Study Coordinator

980-442-2000

Providence Portland Medical Center ( Site 0044)

Recruiting

Portland, Oregon, United States, 97213

Contacts

Study Coordinator

503-215-2619

Providence St. Vincent Medical Center ( Site 0081)

Recruiting

Portland, Oregon, United States, 97225

Contacts

Study Coordinator

503-215-2619

Thomas Jefferson University - Clinical Research Institute ( Site 0056)

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Study Coordinator

215-955-8874

Texas Oncology-Dallas Presbyterian Hospital ( Site 8000)

Recruiting

Dallas, Texas, United States, 75231

Contacts

Study Coordinator

214-265-2080

Parkland Health and Hospital System ( Site 0069)

Recruiting

Dallas, Texas, United States, 75235

Contacts

Study Coordinator

214-590-8000

UT Southwestern Medical Center ( Site 0050)

Recruiting

Dallas, Texas, United States, 75390

Contacts

Study Coordinator

214-648-3111

The Center for Cancer and Blood Disorders ( Site 0041)

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Study Coordinator

817-759-7000

Texas Oncology - San Antonio ( Site 8002)

Recruiting

San Antonio, Texas, United States, 78240

Contacts

Study Coordinator

212-241-0493

The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0057)

Recruiting

Tyler, Texas, United States, 75701

Contacts

Study Coordinator

903-595-7093

Inova Schar Cancer Institute ( Site 0025)

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Study Coordinator

571-472-4724

Bon Secours St. Francis Medical Center-Oncology Research ( Site 0015)

Recruiting

Midlothian, Virginia, United States, 23114

Contacts

Study Coordinator

804-594-7300

VCU Health Adult Outpatient Pavillion ( Site 0070)

Recruiting

Richmond, Virginia, United States, 23219

Contacts

Study Coordinator

877-462-7739

Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 8001)

Recruiting

Roanoke, Virginia, United States, 24014

Contacts

Study Coordinator

844-482-4812

University Hospital and UW Health Clinics-Carbone Cancer Center ( Site 0040)

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Study Coordinator

800-622-8922

BC Cancer Surrey ( Site 0315)

Recruiting

Surrey, British Columbia, Canada, V3V 1Z2

Contacts

Study Coordinator

604-930-2098

Princess Margaret Cancer Centre ( Site 0310)

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Study Coordinator

416-946-5605

CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0301)

Recruiting

Montreal, Quebec, Canada, H1T 2M4

Contacts

Study Coordinator

514-252-3400 x5370

Jewish General Hospital ( Site 0303)

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Contacts

Study Coordinator

514-340-8222

CHU de Quebec Universite Laval - Hopital du Saint-Sacrement ( Site 0302)

Recruiting

Québec, Quebec, Canada, G1S 4L8

Contacts

Study Coordinator

418-682-7511

Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski ( Site 0308)

Recruiting

Rimouski, Quebec, Canada, G5L 5T1

Contacts

Study Coordinator

418 724-3000 x8029

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

Programmed Cell Death-1 (PD1, PD-1)
Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)
Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-09-03.