Epacadostat (INCB024360) Added to Preoperative Chemoradiation in Patients With Locally Advanced Rectal Cancer

Epacadostat (INCB024360) Added to Preoperative Chemoradiation in Patients With Locally Advanced Rectal Cancer is a phase 1/2, interventional study registered as NCT03516708 by Washington University School of Medicine, with a registry enrolment figure of 49 participants, started 2020-01-06 and due to reach its primary completion in 2027-07-15. Interventions recorded: Epacadostat; Short-course radiation therapy; CAPOX chemotherapy; FOLFOX chemotherapy. Conditions listed: Rectal Cancer. Primary outcome: Phase I only: Recommended phase II dose (RP2D) of epacadostat with standard of care radiation and chemotherapy in preoperative treatment of locally advanced rectal cancer; Phase II Treatment Cohort only: Neoadjuvant Rectal (NAR) Score. Colorectal eligibility wording from the registry: "* Newly diagnosed pathologically-confirmed locally advanced rectal cancer (defined by 8th edition AJCC stage 2 or 3, or stage 1 not eligible for sphincter-sparing surgery) with plans to proceed with total neoadjuvant short course radiation as part of their neoadjuvant therapy as confirmed by treatin". Sites: United States. No results are recorded here; the registry entry is the source.