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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

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

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02215

Massachusetts General Hospital,102 Endicott Street
Danvers, Massachusetts 01923

Massachusetts General Hospital,2014 Washington St
Newton, Massachusetts 02462

More Details

Status
Recruiting
Sponsor
Gilead Sciences

Study Contact

Gilead Clinical Study Information Center
1-833-445-3230 (GILEAD-0)
GileadClinicalTrials@gilead.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.