Sacituzumab Govitecan +/- Pembrolizumab in Metastatic TNBC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDana-Farber Cancer Institute
About this trial
This research study involves testing the safety and efficacy of an investigational intervention for patients with triple-negative breast cancer (TNBC) that has spread, or metastasized, to other parts the body and is PD-L1-negative.
The names of the study interventions involved in this study are:
* Sacituzumab govitecan (Trodelvy™;IMMU-132) * Pembrolizumab (Keytruda®; MK-3475)
Eligibility criteria
Qualifiers
Participants must have histologically or cytologically confirmed invasive breast cancer with unresectable locally advanced or metastatic disease. Participants without pathologic or cytologic confirmation of metastatic disease should have unequivocal evidence of metastasis from physical examination or radiologic evaluation.
Estrogen-receptor and progesterone-receptor expression both ≤ 5% by immunohistochemistry (IHC), and HER2-negative status as determined by the current ASCO/CAP guidelines. If a patient has more than one histological result, the most recent sample will be considered for inclusion.
Participants must have PD-L1-negative metastatic breast cancer defined as less than 1% expression of PD-L1 on tumor-infiltrating immune cells (IC) by the PD-L1 IHC SP142 assay or a Combined Positive Score (CPS) less than 10 by the PD-L1 IHC 22C3 assay measured with standard of care testing.
Participants must be treatment-naïve in the metastatic setting.
Disqualifiers
Has received prior systemic anti-cancer therapy, including investigational agents, within 4 weeks of study treatment initiation or during the course of this study (bisphosphonates and RANK ligand inhibitors are allowed).
Prior therapy with any anti-PD-1, PD-L1, or PD-L2 agent or sacituzumab govitecan (IMMU-132). Prior therapy with irinotecan or topoisomerase I-containing antibody drug conjugates at any time for early stage or metastatic disease.
Prior hypersensitivity to pembrolizumab or the excipients of pembrolizumab or sacituzumab govitecan (IMMU-132 therapy).
Known history of UDP-glucuronosyltransferase 1A1 (UGT1A1) *28 allele homozygosity, which is associated with increased risk for neutropenia and diarrhea related to irinotecan. Note: Concurrent administration of strong UGT1A1 inhibitors or inducers is not allowed during the course of the study.
Trial design
Treatments tested in this trial
- Sacituzumab Govitecan
- Pembrolizumab
Treatment groups
110 Participants
are divided into 3 treatment groupsSponsors and collaborators
Dana-Farber Cancer Institute
Lead sponsor
Gilead Sciences
Collaborator
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov