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)

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40

ClinicalTrials ID:NCT06312176

This study evaluates sacituzumab tirumotecan alone and with pembrolizumab against physician's choice treatments in HR+/HER2- advanced breast cancer. Eligible participants must have progressed on endocrine therapy and be chemotherapy candidates. Interventions include sacituzumab tirumotecan, pembrolizumab, and various chemotherapy options. Exclusions include curative treatment potential and prior chemotherapy for advanced disease.

Patient Parameters

Program Overview

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.

Eligibility Criteria

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

Locations

FACILITYZIPCITYSTATE
Ironwood Cancer & Research Centers ( Site 0066)85224ChandlerArizona
Providence Medical Foundation-Oncology ( Site 0020)92835FullertonCalifornia
Moores Cancer Center ( Site 0059)92093-0698La JollaCalifornia
Cancer and Blood Specialty Clinic ( Site 0001)90720Los AlamitosCalifornia
Yale Cancer Center ( Site 0060)06510New HavenConnecticut
AdventHealth Altamonte Springs ( Site 0021)32701Altamonte SpringsFlorida
Orlando Health Cancer Institute ( Site 0011)32806OrlandoFlorida
Archbold Memorial Hospital-Lewis Hall Singletary Oncology Center ( Site 0032)31792ThomasvilleGeorgia
University of Chicago Medical Center ( Site 0067)60637ChicagoIllinois
Mary Bird Perkins Cancer Center-Breast & GYN Pavilion ( Site 0042)70817Baton RougeLouisiana

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