Description
PRIMARY OBJECTIVE:
I. To determine the frequency of patients responding (response rate) to talimogene laherparepvec monotherapy.
SECONDARY OBJECTIVES:
I. To determine the local response rate to talimogene laherparepvec in injected tumors.
II. To determine the response rate to talimogene laherparepvec + nivolumab (NIVO).
III. To identify potential pre-treatment and on-treatment correlative biomarkers of local and systemic immune response.
OUTLINE:
Patients receive talimogene laherparepvec intratumorally (IT) and nivolumab intravenously (IV) over 30 minutes on day 1. Cycles repeat every 21 days for cycle 1 then every 14 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) scan or positron emission tomography (PET)/CT scan on study. Patients also undergo blood sample collection and biopsies on study.
After completion of study treatment, patients are followed up every 12 weeks for 3 years.