IRX-2, Cyclophosphamide, and Nivolumab in Treating Patients With Recurrent or Metastatic and Refractory Liver Cancer

Description

PRIMARY OBJECTIVES:

I. To determine the safety profile of combination IRX?2 regimen and nivolumab in anti?PD?1/PD?L1 naive patients who have failed or not tolerated at least one line of treatment.

SECONDARY OBJECTIVES:

I. To evaluate the overall response rate of IRX?2 regimen combined with nivolumab using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and immune modified RECIST criteria.

II. To evaluate the rate of 6?month progression?free survival in patients treated with combination IRX?2 regimen with nivolumab.

III. To evaluate median progression?free survival and overall survival.

EXPLORATORY OBJECTIVES:

I. To evaluate the circulating T cell profiles in patients before and after therapy with the combination IRX?2 regimen and nivolumab.

II. To explore identification of tumor tissue neoantigens through a multiplex proteomic assay (MHC?PepSeq) paired with tumor genomic and transcriptomic sequencing.

III. To explore putative biomarkers (including circulating tumor deoxyribonucleic acid [DNA] and immune cell profiles) in peripheral blood to generate hypotheses for response to treatment with combination IRX?2 regimen and nivolumab.

OUTLINE: This is a dose-escalation study of IRX-2.

Patients receive nivolumab intravenously (IV) over 30 minutes on day 1, cyclophosphamide IV on day 1, and IRX-2 subcutaneously (SC) for 10 days between days 4 and 15. Cycles repeat every 28 days for up to 18 months in the absence of disease progression or unacceptable toxicity. Patients receive booster IRX-2 SC at 3, 6, 9, 12, and 15 months.

After completion of study treatment, patients are followed up every 12 weeks.