Saci Nivo Rela for TNBC
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University
About this trial
This is a randomized, open-label, phase Ib study to assess safety and efficacy of sacituzumab govitecan plus nivolumab or sacituzumab govitecan plus a fixed dose combination of nivolumab and relatlimab in patients with any programmed cell death-ligand 1 (PD-L1) status metastatic, triple negative breast cancer on routine testing with one prior line of cytotoxic chemotherapy with or without immunotherapy in the metastatic setting. The study treatment will be continued until the progression of disease, unacceptable toxicity, death, or withdrawal of consent for any reason.
Eligibility criteria
Qualifiers
Must be competent and able to comprehend, sign, and date an IRB approved ICF before the performance of any study specific procedures or tests.
Participants 18 years or older.
Is defined as unresectable/metastatic disease.
Is Human Epidermal Growth Factor Receptor 2 (HER2)-negative, defined as HER2- immunohistochemistry (IHC) 0, 1+ or 2+ ISH negative, and estrogen receptor (ER)- and progesterone receptor (PgR)- negative, both defined as IHC <10%
Disqualifiers
Participants who are pregnant or lactating.
Participants of childbearing potential or fertile men unwilling to use effective contraception.
Concomitant metastatic disease from other primary tumors.
Known history of unstable angina, MI, or CHF present within six months of randomization or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy.
Trial design
Treatments tested in this trial
- Relatlimab FDC + Nivolumab
- Sacituzumab Govitecan (SG)
- Nivolumab
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Yale University
Lead sponsor
Bristol-Myers Squibb
Collaborator
Source ClinicalTrials.gov