Anatomic Stage II Breast Cancer AJCC v8 Clinical Trial
Official title:
A Phase 1 Study of Ipilumumab, Nivolumab and Talimogene Laherparepvec Preoperative Treatment of Localized Breast Cancer-deleted
This phase I trial studies talimogene laherparepvec given together with ipilimumab and nivolumab before surgery in patients with triple-negative or estrogen receptor positive, HER2 negative localized breast cancer. Ipilimumab and Nivolumab are immune checkpoint inhibitors that enhance immune response towards cancer cells. Talimogene laherparepvec is a modifies human herpes virus 1 that is an oncolytic virus targeting cancer cells and makes tumor microenvironment more immunogenic to promote immune response against cancer. This study will assess the safety and efficacy of talimogene laherparepvec, ipilimumab, and nivolumab, and provide an insight for further improvement of immunotherapy in breast cancer.
PRIMARY OBJECTIVES: I. To explore the safety of talimogene laherparepvec in combination with nivolumab and ipilimumab in this population assessed by the frequency and severity of adverse events (AEs) using Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0 toxicity criteria. SECONDARY OBJECTIVES: I. Assess tumor response of talimogene laherparepvec in combination with nivolumab and ipilimumab comparing to no treatment, in subjects with localized estrogen receptor (ER) positive and triple negative infiltrating ductal breast cancer. II. Descriptively analyze the evidence of tumor necrosis and inflammatory infiltration on histopathological examination and immuno-oncological findings in tumor and peripheral blood of patients treated with talimogene laherparepvec in combination with nivolumab and ipilimumab. EXPLORATORY OBJECTIVES: I. Descriptively compare tumor response in patients whose tumors are PD-L1 positive (+) and PD-L1 negative (-) at baseline. II. Determine the baseline mutational load of patients at the start of treatment and relate it to the response to treatment. III. Determine if hormone receptor status correlates with tumor responses. IV. Determine the number of tumor infiltrating lymphocytes in patient samples at the start and at the end of treatment and relate them to tumor response. V. Analyze T-cell receptor (TCR) repertoire in tumor infiltrating lymphocytes and peripheral blood mononuclear cells. OUTLINE: Participants receive talimogene laherparepvec intratumorally on days 1, 22, and 36, nivolumab intravenously (IV) over 60 minutes on days 1, 15, 29, and 43, and ipilimumab IV over 90 minutes on days 1 and 43 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, participants are followed up for 30 days. ;
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