Metastatic Gastroesophageal Junction Adenocarcinoma Clinical Trial
Official title:
A Phase 1b/2 Trial of the IRX-2 Regimen and Pembrolizumab in Patients With Advanced Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma
This phase Ib/II trial studies the side effects of IRX-2, cyclophosphamide, and pembrolizumab work in treating participants with gastric or gastroesophageal junction cancer that has come back or that has spread to other places in the body. Interleukins, such as those found in IRX-2, are proteins made by white blood cells and other cells in the body and may help regulate immune response. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving RX-2, cyclophosphamide, and pembrolizumab may work better in treating participants with gastric or gastroesophageal junction cancer.
PRIMARY OBJECTIVES: I. To determine the safety profile of combination IRX-2 regimen and pembrolizumab. SECONDARY OBJECTIVES: I. To evaluate the overall response rate of IRX-2 regimen combined with pembrolizumab using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and immune modified RECIST criteria. II. To evaluate initial median progression-free and overall survival in these patients treated with combination IRX-2 regimen and pembrolizumab. EXPLORATORY OBJECTIVES: I. To evaluate the circulating T cell profiles in patients before and after therapy with combination IRX-2 regimen and pembrolizumab. II. To evaluate the baseline and post-treatment tumor tissue immune gene expression profiling using the Nanostring platform. III. To explore identification of tumor tissue neoantigens through a multiplex proteomic assay (MHC-PepSeq) paired with tumor genomic and transcriptomic sequencing. IV. 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 pembrolizumab. OUTLINE: Participants receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Participants also receive cyclophosphamide IV on day 1 and IRX-2 subcutaneously (SC) for 10 days starting on day 4 during cycles 1, 5, 9, 13, 17, 21, 25, 29, and 33. Treatment repeats every 3 weeks for up to 35 cycles in the absence of disease or unacceptable toxicity. After completion of study treatment, participants are followed up for 30 days and then up to 1 year. ;
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