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MK-2870 as a Single Agent and in Combination With MK-3475 Versus TPC (MK-2870-010)

  • Status
    Accepting Candidates
  • Age
    18 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

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.

Details

Full study title 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
Protocol number OCR45818
ClinicalTrials.gov ID NCT06312176
Phase Phase 3

Eligibility

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 (

Lead researcher

  • Karen Daily, DO
    Cancer Specialist (Oncologist), Hematology and Oncology Specialist
    Karen Daily

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    Get screened to confirm eligibility

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