Ipilimumab, Nivolumab, and Talimogene Laherparepvec Before Surgery in Treating Participants With Localized, Triple-Negative or Estrogen Receptor Positive, HER2 Negative Breast Cancer-deleted

Summary

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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. SECON...

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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