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)

Purpose

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.

Condition

  • Breast Neoplasms

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: Sacituzumab tirumotecan
    IV infusion
    Other names:
    • MK-2870
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).
  • Drug: Sacituzumab tirumotecan
    IV infusion
    Other names:
    • MK-2870
  • Biological: Pembrolizumab
    IV infusion
    Other names:
    • MK-3475
    • KEYTRUDA®
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.
  • Drug: Paclitaxel
    IV infusion
    Other names:
    • TAXOL®
  • Drug: Nab-paclitaxel
    IV infusion
    Other names:
    • ABRAXANE®
  • Drug: Capecitabine
    oral tablet
    Other names:
    • XELODA®
  • Drug: Liposomal doxorubicin
    IV infusion
    Other names:
    • DOXIL®

Recruiting Locations

Ironwood Cancer & Research Centers ( Site 0066)
Chandler, Arizona 85224
Contact:
Study Coordinator
480-821-2838

Banner MD Anderson Cancer Center-Oncology ( Site 0004)
Gilbert, Arizona 85234
Contact:
Study Coordinator
480-256-6444

Providence Medical Foundation-Oncology ( Site 0020)
Fullerton, California 92835
Contact:
Study Coordinator
714-446-5900

Cancer and Blood Specialty Clinic ( Site 0001)
Los Alamitos, California 90720
Contact:
Study Coordinator
562-353-1200

University of Colorado Anschutz Medical Campus ( Site 0061)
Aurora, Colorado 80045
Contact:
Study Coordinator
303-724-6077

UCHealth Cherry Creek Medical Center ( Site 0094)
Denver, Colorado 80206
Contact:
Study Coordinator
720-848-1030

Yale Cancer Center ( Site 0060)
New Haven, Connecticut 06510
Contact:
Study Coordinator
203-688-4242

Stamford Hospital ( Site 0049)
Stamford, Connecticut 06902
Contact:
Study Coordinator
203-276-1000

AdventHealth Altamonte Springs ( Site 0021)
Altamonte Springs, Florida 32701
Contact:
Study Coordinator
407-834-5151

Orlando Health Cancer Institute ( Site 0011)
Orlando, Florida 32806
Contact:
Study Coordinator
321-843-8370

Archbold Memorial Hospital-Lewis Hall Singletary Oncology Center ( Site 0032)
Thomasville, Georgia 31792
Contact:
Study Coordinator
229-584-5400

Rush University Medical Center ( Site 0079)
Chicago, Illinois 60607
Contact:
Study Coordinator
312-942-3498

University of Chicago Medical Center ( Site 0067)
Chicago, Illinois 60637
Contact:
Study Coordinator
773-702-6149

Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0053)
Edgewood, Kentucky 41017
Contact:
Study Coordinator
859-301-4245

Mary Bird Perkins Cancer Center-Breast & GYN Pavilion ( Site 0042)
Baton Rouge, Louisiana 70817
Contact:
Study Coordinator
888-501-4763

Greenebaum Comprehensive Cancer Center ( Site 0036)
Baltimore, Maryland 21201
Contact:
Study Coordinator
410-328-6373

Holy Cross Hospital ( Site 0073)
Silver Spring, Maryland 20910
Contact:
Study Coordinator
301-754-7000

Dana-Farber Cancer Institute-Breast Oncology Center ( Site 0037)
Boston, Massachusetts 02215
Contact:
Study Coordinator
857-215-3246

Henry Ford Health ( Site 0002)
Detroit, Michigan 48202
Contact:
Study Coordinator
313-916-2576

Saint Luke's Cancer Institute ( Site 0027)
Kansas City, Missouri 64111
Contact:
Study Coordinator
816-932-2677

Washington University School of Medicine ( Site 0076)
St Louis, Missouri 63110
Contact:
Study Coordinator
314-454-8313

NYU Langone Health - Brooklyn ( Site 0089)
Brooklyn, New York 11220
Contact:
Study Coordinator
212-731-6000

NYU Langone Hospital - Long Island ( Site 0090)
Mineola, New York 11501
Contact:
Study Coordinator
212-731-6000

Laura and Isaac Perlmutter Cancer Center-Hematology and Oncology ( Site 0068)
New York, New York 10016
Contact:
Study Coordinator
212-731-6000

Hematology Oncology Associates of Rockland ( Site 0054)
Nyack, New York 10960
Contact:
Study Coordinator
845-362-1750

Stony Brook University-Cancer Center ( Site 0034)
Stony Brook, New York 11794
Contact:
Study Coordinator
631-444-4392

Levine Cancer Institute ( Site 0014)
Charlotte, North Carolina 28204
Contact:
Study Coordinator
980-442-2000

Providence Portland Medical Center ( Site 0044)
Portland, Oregon 97213
Contact:
Study Coordinator
503-215-2619

Providence St. Vincent Medical Center ( Site 0081)
Portland, Oregon 97225
Contact:
Study Coordinator
503-215-2619

Thomas Jefferson University - Clinical Research Institute ( Site 0056)
Philadelphia, Pennsylvania 19107
Contact:
Study Coordinator
215-955-8874

Texas Oncology-Dallas Presbyterian Hospital ( Site 8000)
Dallas, Texas 75231
Contact:
Study Coordinator
214-265-2080

Parkland Health and Hospital System ( Site 0069)
Dallas, Texas 75235
Contact:
Study Coordinator
214-590-8000

UT Southwestern Medical Center ( Site 0050)
Dallas, Texas 75390
Contact:
Study Coordinator
214-648-3111

The Center for Cancer and Blood Disorders ( Site 0041)
Fort Worth, Texas 76104
Contact:
Study Coordinator
817-759-7000

Texas Oncology - San Antonio ( Site 8002)
San Antonio, Texas 78240
Contact:
Study Coordinator
212-241-0493

The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0057)
Tyler, Texas 75701
Contact:
Study Coordinator
903-595-7093

Inova Schar Cancer Institute ( Site 0025)
Fairfax, Virginia 22031
Contact:
Study Coordinator
571-472-4724

Bon Secours St. Francis Medical Center-Oncology Research ( Site 0015)
Midlothian, Virginia 23114
Contact:
Study Coordinator
804-594-7300

VCU Health Adult Outpatient Pavillion ( Site 0070)
Richmond, Virginia 23219
Contact:
Study Coordinator
877-462-7739

Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 8001)
Roanoke, Virginia 24014
Contact:
Study Coordinator
844-482-4812

University Hospital and UW Health Clinics-Carbone Cancer Center ( Site 0040)
Madison, Wisconsin 53792
Contact:
Study Coordinator
800-622-8922

UPR Comprehensive Cancer Center-Comprehensive Cancer Center Hospital ( Site 0677)
San Juan, Puerto Rico 00935
Contact:
Study Coordinator
7877728300 Ext 1226

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com