Rectal Cancer Clinical Trial
Official title:
Study of Epacadostat (INCB024360) Added to Preoperative Chemoradiation in Patients With Locally Advanced Rectal Cancer
The purpose of this research study is to evaluate epacadostat when given with routine radiation therapy and chemotherapy (capecitabine and oxaliplatin) to treat rectal cancer before routine surgery is performed to remove the tumor. The Phase II portion of the trial has not started recruiting.
Based on preclinical data from Ciorba Lab (WUSM) the investigators hypothesize that "SCRT is a foundational regimen to examine adjunctive immunotherapy in LARC and that inhibition of IDO1 mediated tryptophan metabolism will safely improve anti-tumor immunity and therapeutic response to SCRT based therapy." In this multi-center phase II clinical trial, first 20 patients will be randomized to either Treatment Cohort or Biomarker Cohort. Patients on Biomarker Cohort will undergo standard SCRT and CAPOX chemotherapy, and provide research biopsies before and after SCRT, and at the time of surgery. Patients on Treatment Cohort will receive epacadostat 400mg twice daily, along with standard SCRT and CAPOX chemotherapy. After the first 20 patients, additional patients will be enrolled to Treatment Cohort until 27 patients who are evaluable for the primary endpoint are enrolled. Patients will be assessed for clinical outcomes including response to therapy as measured by neoadjuvant rectal score (NAR score), local and distant control of their disease, toxicities and survival. Up to 37 evaluable patients (27 patients in treatment cohort and 10 patients in biomarker cohort) of any gender, race, or ethnicity with locally advanced rectal cancer will be included in this clinical trial. Tumor and blood samples will be collected for analyses to determine factors that underlie treatment response or resistance. ;
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