RecruitingPhase 1Phase 2NCT06963905

Saci Nivo Rela for TNBC

Phase Ib Randomized Open-label Trial of Sacituzumab Govitecan Plus Nivolumab or Sacituzumab Govitecan Plus Nivolumab and Relatlimab as Second-line Therapy for Patients With Metastatic Triple Negative Breast Cancer

Sponsor

Yale University

Enrollment

60 participants

Start Date

Dec 29, 2025

Study Type

INTERVENTIONAL

Conditions

Metastatic Triple-negative Breast Cancer

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three cancer drugs — sacituzumab govitecan, nivolumab, and relacorilant — for people with triple-negative breast cancer (a type that doesn't respond to hormone therapies) that has spread or cannot be surgically removed. **You may be eligible if...** - You are 18 or older - You have metastatic or unresectable breast cancer confirmed as triple-negative (HER2-negative, and estrogen/progesterone receptor-negative) - You are in reasonable health (able to carry out daily activities) **You may NOT be eligible if...** - You have active brain metastases (cancer that has spread to the brain and is causing symptoms) - You have serious heart, liver, or kidney problems - You are pregnant or breastfeeding - You have had certain prior treatments that would interfere with this combination Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRelatlimab FDC + Nivolumab

Relatlimab: 360 IV Q3W (Dose level 1) and 120mg IV Q3W (Dose level -1) Nivolumab: 360mg IV Q3W

DRUGSacituzumab Govitecan (SG)

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)

DRUGNivolumab

360mg IV Q3W

Locations(1)

Yale University

New Haven, Connecticut, United States

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NCT06963905

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