OncoMatch/Clinical Trials/NCT06963905
Saci Nivo Rela for TNBC
Is NCT06963905 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments including Relatlimab FDC + Nivolumab and Sacituzumab Govitecan (SG) for metastatic triple-negative breast cancer.
Treatment: Relatlimab FDC + Nivolumab · Sacituzumab Govitecan (SG) · Nivolumab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) negative (IHC 0, 1+ or 2+ ISH negative) (IHC 0, 1+ or 2+ ISH negative)
HER2-negative, defined as HER2- immunohistochemistry (IHC) 0, 1+ or 2+ ISH negative
Required: ESR1 negative (IHC <10%) (IHC <10%)
estrogen receptor (ER)-negative, defined as IHC <10%
Required: PR (PGR) negative (IHC <10%) (IHC <10%)
progesterone receptor (PgR)-negative, defined as IHC <10%
Allowed: PD-L1 (CD274) any tested
Any PD-L1 status measured by IHC via CPS by IHC (defined by the number of PD-L1 staining cells [tumor cells, lymphocytes, macrophages] divided by the total number of viable tumor cells, multiplied by 100) via FDA-approved SP263 assay.
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: immune checkpoint inhibitor with systemic chemotherapy — neo(adjuvant) or metastatic
Prior immune checkpoint inhibition with systemic chemotherapy is required in either neo(adjuvant) or metastatic settings
Cannot have received: LAG-3 targeted agent (relatlimab)
Participants must not have had prior treatment with relatlimab or any other LAG-3 targeted agent
Cannot have received: TROP2 antibody-drug conjugate (SG)
no prior SG or other TROP2-ADCs
Lab requirements
Cardiac function
left ventricular ejection fraction (lvef) ≥50% within 6 months prior to enrolment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Yale University · New Haven, Connecticut
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06963905 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior LAG-3 targeted agent, TROP2 antibody-drug conjugate disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative (IHC 0, 1+ or 2+ ISH negative) is a required biomarker for enrollment.
Does this trial require ESR1?
Yes, ESR1 negative (IHC <10%) is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR negative (IHC <10%) is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify