Study on Sacituzumab Govitecan, Nivolumab, and Relatlimab for Metastatic Triple Negative Breast Cancer

Sponsor: Yale University

Sponsor score: 40

ClinicalTrials ID:NCT06963905

Provider View

This clinical trial is testing a combination of drugs, including sacituzumab govitecan, nivolumab, and relatlimab, to see if they are safe and effective for patients with advanced triple negative breast cancer that has spread and is positive for PD-L1. Participants must have previously received chemotherapy with pembrolizumab.

Patient Parameters

Program Overview

The study aims to evaluate the safety and effectiveness of combining sacituzumab govitecan with nivolumab, or with a fixed dose of nivolumab and relatlimab, in patients with metastatic triple negative breast cancer that is PD-L1 positive. The treatment will continue until the cancer progresses, side effects become unacceptable, the patient decides to stop, or other reasons like death. Patients will be monitored for up to two years, with regular checks on their safety and how their tumors respond to the treatment.

Description

This study is designed to test the safety and effectiveness of a drug combination for patients with advanced triple negative breast cancer that is PD-L1 positive. The drugs being tested are sacituzumab govitecan, nivolumab, and relatlimab. Patients will receive these treatments until their cancer progresses, they experience severe side effects, or they choose to stop. The study will monitor patients' safety and tumor response every nine weeks. The main goal is to see how safe the treatment is, while secondary goals include measuring how well the cancer responds, how long the response lasts, and overall survival rates. Patients will have a follow-up visit about 135 days after their last treatment, and then every three months for two years to track their health and survival.

Eligibility Criteria

Inclusion Criteria

  • Must be able to understand and sign a consent form.
  • Age 18 or older.
  • Have advanced breast cancer that cannot be removed by surgery and is HER2-negative and hormone receptor-negative.
  • Cancer must be PD-L1 positive.
  • Have received one prior chemotherapy treatment with pembrolizumab for metastatic cancer.
  • Have shown cancer progression or intolerance to previous treatment.
  • Must provide a recent tumor sample for PD-L1 testing.
  • Have measurable or non-measurable cancer based on scans.
  • Be in good general health with a performance status of 0 or 1.
  • Have a heart function of at least 50%.
  • Meet specific blood test requirements.
  • Use effective contraception if of childbearing potential, and agree to not donate eggs or sperm during and after the study for a specified period.

Exclusion Criteria

  • Pregnant or breastfeeding women.
  • Those unwilling to use effective contraception.
  • Have other serious health conditions, such as:
    • Other active cancers.
    • Recent heart problems or severe lung disease.
    • History of severe lung inflammation or gastrointestinal perforation.
    • Active infections requiring treatment.
    • Uncontrolled HIV or hepatitis infections.
    • Active autoimmune diseases requiring treatment.
  • Have untreated or symptomatic brain metastases.
  • Have unresolved side effects from previous cancer treatments.
  • Have severe allergies to study drugs or similar medications.
  • Have previously received certain treatments like relatlimab.
  • Have substance abuse issues or other factors that may interfere with the study.

Locations

FACILITYZIPCITYSTATE
Yale University06510New HavenConnecticut

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