Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer

Purpose

The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician's choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (PD-L1).

Conditions

  • Triple Negative Breast Cancer
  • PD-L1 Positive

Eligibility

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

Inclusion Criteria

  • Individuals with locally advanced, inoperable, or metastatic triple-negative breast cancer (TNBC) who have not received previous systemic therapy for advanced disease and whose tumors are programmed cell death ligand 1 (PD-L1) positive at screening. - Individuals must have completed treatment for Stage I to III breast cancer, if indicated, and ≥ 6 months must have elapsed between completion of treatment with curative intent and first documented local or distant disease recurrence. - Individuals presenting with de novo metastatic TNBC are eligible for this study. - TNBC status and tumor PD-L1 combined positive score (CPS) will be confirmed centrally on a recent or archival tumor specimen. - Individuals must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria as evaluated locally. - Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. - Demonstrates adequate organ function - Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception. - Individuals with HIV must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease.

Exclusion Criteria

  • Positive serum pregnancy test or women who are lactating. - Received prior therapy with an agent directed to another stimulatory or coinhibitory T-cell receptor. - Individuals may not have received systemic anticancer treatment (with the exception of endocrine therapy) within the previous 6 months or radiation therapy within 2 weeks prior to enrollment. - Individuals may not be participating in a study with an investigational agent or investigational device within 4 weeks prior to randomization. Individuals participating in observational studies are eligible. - Have previously received topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase inhibitor. - Have an active second malignancy. - Have active serious infection requiring antibiotics. - Individuals positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease. - Have active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. - Has an active autoimmune disease that has required systemic treatment in the past 2 years. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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
Sacituzumab Govitecan-hziy (SG) + Pembrolizumab 		Participants will receive SG 10 mg/kg on Days 1 and 8 of 21-day cycles and pembrolizumab 200 mg on Day 1 of 21-day cycles Pembrolizumab will be administered for a maximum of 35 cycles.
  • Drug: Sacituzumab Govitecan-hziy
    Administered intravenously
    Other names:
    • IMMU-132
    • Trodelvy™
    • GS-0132
  • Drug: Pembrolizumab
    Administered intravenously
    Other names:
    • KEYTRUDA®
Active Comparator
Pembrolizumab + Treatment of Physician's Choice (TPC) 		Participants will receive pembrolizumab 200 mg on Day 1 of each 21-day cycle (maximum 35 cycles) plus TPC determined prior to randomization from 1 of the 3 allowed regimens: - Paclitaxel 90 mg/m^2 on Days 1, 8, and 15 of 28-day cycles - nab-Paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of 28-day cycles - Gemcitabine 1000 mg/m^2 + carboplatin area under the curve (AUC) 2 on Days 1 and 8 of 21-day cycles
  • Drug: Pembrolizumab
    Administered intravenously
    Other names:
    • KEYTRUDA®
  • Drug: Paclitaxel
    Administered intravenously
    Other names:
    • Taxol®
  • Drug: nab-Paclitaxel
    Administered intravenously
    Other names:
    • Abraxane®
  • Drug: Gemcitabine
    Administered intravenously
    Other names:
    • Gemzar
  • Drug: Carboplatin
    Administered intravenously

More Details

Status
Active, not recruiting
Sponsor
Gilead Sciences

Study Contact