Saci Nivo Rela for TNBC

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT06963905
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Metastatic Triple-negative Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Relatlimab FDC + Nivolumab — DRUG
    Relatlimab: 360 IV Q3W (Dose level 1) and 120mg IV Q3W (Dose level -1) Nivolumab: 360mg IV Q3W
  • Sacituzumab Govitecan (SG) — DRUG
    10 mg/kg IV D1 \& D8 every 21-day cycles (Dose level 1); 7.5 mg/kg IV D1 \& D8 every 21-day cycles (Dose level -1); 5 mg/kg IV D1 \& D8 every 21-day cycles 21-day cycles (Dose level -2)
  • Nivolumab — DRUG
    360mg IV Q3W

Study Details

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.

Key Dates

Start date
Dec 29, 2025
Status verified
May 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A
    Sacituzumab govitecan plus a fixed dose combination of nivolumab and relatlimab
  • Active Comparator: Arm B
    Sacituzumab Govitecan plus nivolumab

Primary Outcome Measure

Incidence and severity of dose limiting toxicities in patients treated with sacituzumab govitecan combinations [ Time Frame: Three weeks post-Cycle 1 Day 1 (each cycle is 21 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06510
Carl Brown
[email protected]
2037854095

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By research site
Yale University· New Haven, CT

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