Actively Recruiting
Saci Nivo Rela for TNBC
Led by Yale University · Updated on 2026-02-17
60
Participants Needed
1
Research Sites
256 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Saci Nivo Rela for TNBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and sign informed consent
- Age 18 years or older
- Diagnosed with unresectable or metastatic HER2-negative, ER-negative, and PgR-negative breast cancer
- Any PD-L1 status as measured by FDA-approved assay
- Received up to one prior line of systemic cytotoxic chemotherapy with or without immunotherapy in metastatic setting
- Prior immune checkpoint inhibition with systemic chemotherapy required
- Have documented disease progression or intolerance to prior therapy needing change
- Have an archival tumor sample less than 3 years old or able to undergo new biopsy
- May have measurable or non-measurable lesions by RECIST 1.1 criteria
- ECOG performance status 0 or 1
- Left ventricular ejection fraction 50% or higher within 6 months prior to enrollment
- Adequate laboratory test results within 14 days of first treatment
- Adequate contraception and pregnancy prevention measures if applicable
You will not qualify if you...
- Pregnant or breastfeeding
- Childbearing potential or fertile men unwilling to use effective contraception
- Having metastatic disease from other primary tumors
- History of unstable angina, myocardial infarction, congestive heart failure within 6 months, or significant arrhythmia needing treatment
- History of myocarditis
- Moderate to severe chronic respiratory illness or active COPD within 6 months
- History of pneumonitis or interstitial lung disease requiring prolonged steroid treatment, or current pneumonitis
- Gastrointestinal perforation within 6 months
- Uncontrolled infection requiring intravenous antibiotics, antivirals, or antifungals
- HIV infection with detectable viral load or low CD4 count, or active hepatitis B or C infection
- Active autoimmune or inflammatory disorders requiring immunomodulatory or corticosteroid treatment in past 2 years (exceptions apply)
- Untreated spinal cord compression
- Clinically active brain metastases needing corticosteroids
- Unresolved toxicities from prior cancer therapy above grade 1 except alopecia
- History of severe allergic reactions to study drugs or monoclonal antibodies
- Prior treatment with relatlimab, LAG-3 agents, sacituzumab govitecan, or other TROP2 antibody-drug conjugates
- Substance abuse or medical/social conditions that increase safety risk or interfere with study participation
- Insufficient washout period from prior therapies before first treatment day
AI-Screening
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Trial Site Locations
Total: 1 location
1
Yale University
New Haven, Connecticut, United States, 06510
Actively Recruiting
Research Team
L
Laura Kane
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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