Health TrialsbyHealthPanel

Saci Nivo Rela for TNBC

ConditionMetastatic Triple-negative Breast Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Must be competent and able to comprehend, sign, and date an IRB approved ICF before the performance of any study specific procedures or tests.

Participants 18 years or older.

Is defined as unresectable/metastatic disease.

Is Human Epidermal Growth Factor Receptor 2 (HER2)-negative, defined as HER2- immunohistochemistry (IHC) 0, 1+ or 2+ ISH negative, and estrogen receptor (ER)- and progesterone receptor (PgR)- negative, both defined as IHC <10%

Disqualifiers

Participants who are pregnant or lactating.

Participants of childbearing potential or fertile men unwilling to use effective contraception.

Concomitant metastatic disease from other primary tumors.

Known history of unstable angina, MI, or CHF present within six months of randomization or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Arm AActive comparator 2 interventions
Group B: Arm BActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Incidence and severity of dose limiting toxicities in patients treated with sacituzumab govitecan combinations

The primary outcome measure is the incidence of dose-limiting toxicities (DLTs) observed three weeks after the first cycle of treatment with sacituzumab govitecan in combination with nivolumab, or sacituzumab govitecan in combination with nivolumab and relatlimab fixed-dose combination in patients with advanced triple-negative breast cancer in the second-line setting. The assessment will include the frequency and severity of DLTs to evaluate the safety and tolerability of the treatment regimens.

Time frame
Three weeks post-Cycle 1 Day 1 (each cycle is 21 days)

Secondary outcomes

1

Time to response in patients treated with sacituzumab govitecan combinations

Time to Response is defined as the time from the initiation of treatment to the first documentation of a complete response or partial response in patients with advanced TNBC in the second-line setting. This outcome measure will assess the efficacy of sacituzumab govitecan in combination with nivolumab, or sacituzumab govitecan in combination with nivolumab and relatlimab FDC, by measuring how quickly patients respond to the therapy..

Time frame
At baseline (Week 0), followed by assessments every 9 weeks (Weeks 9, 18, 27, 36, etc.). The final assessment will take place at the end of the trial, during the last follow-up visit, which will occur 4 weeks post-treatment or upon study completion
2

Overall response rate in patients treated with sacituzumab govitecan combinations

The Overall Response Rate is defined as the proportion of patients with advanced triple-negative breast cancer in the second-line setting who achieve either a complete response or partial response according to the RECIST version 1.1. The ORR will be assessed in patients receiving sacituzumab govitecan combined with nivolumab, or sacituzumab govitecan combined with nivolumab and relatlimab fixed-dose combination (FDC). This outcome measure aims to evaluate the preliminary efficacy of the treatment regimens.

Time frame
At baseline (Week 0), followed by assessments every 9 weeks (Weeks 9, 18, 27, 36, etc.). The final assessment will take place at the end of the trial, during the last follow-up visit, which will occur 4 weeks post-treatment or upon study completion
3

Duration of response in patients treated with sacituzumab govitecan combinations

The Duration of Response is defined as the time from the first documentation of a complete response or partial response until the time of disease progression or death from any cause, whichever occurs first. This measure will be evaluated in patients with advanced TNBC in the second-line setting who respond to treatment with sacituzumab govitecan plus nivolumab, or sacituzumab govitecan plus nivolumab and relatlimab FDC. The objective is to determine the sustainability of the responses induced by the treatment combinations.

Time frame
At baseline (Week 0), followed by assessments every 9 weeks (Weeks 9, 18, 27, 36, etc.). The final assessment will take place at the end of the trial, during the last follow-up visit, which will occur 4 weeks post-treatment or upon study completion
4

Clinical benefit rate in patients treated with sacituzumab govitecan combinations

The Clinical Benefit Rate is defined as the proportion of patients who achieve a complete response, partial response, or stable disease for at least 6 months, according to RECIST version 1.1. This measure will be assessed in patients with advanced TNBC in the second-line setting undergoing treatment with sacituzumab govitecan plus nivolumab, or sacituzumab govitecan plus nivolumab and relatlimab FDC. The CBR will help determine the overall efficacy and potential benefit of the treatment regimens.

Time frame
At baseline (Week 0), followed by assessments every 9 weeks (Weeks 9, 18, 27, 36, etc.). The final assessment will take place at the end of the trial, during the last follow-up visit, which will occur 4 weeks post-treatment or upon study completion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

Bristol-Myers Squibb

Collaborator

Source ClinicalTrials.gov
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