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

Source: https://onco.cc/trials/nct03516708/  
OnCo record `nct03516708` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 1/2 trial of epacadostat in colorectal cancer, run by Washington University School of Medicine, now recruiting.

## Summary

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.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-24
- Tags: ctgov-ingest; colorectal-deep-dive
- Registry id: NCT03516708
- Phase: 1/2
- Setting: Phase I/II Study of Epacadostat (INCB024360) Added to Preoperative Chemoradiation in Patients With Locally Advanced Rectal Cancer
- Sponsor: Washington University School of Medicine
- Enrolled: 49

## Sources

- ClinicalTrials.gov NCT03516708: https://clinicaltrials.gov/study/NCT03516708

## Connected records

- cancers: [Rectal cancer](https://onco.cc/cancers/rectal-cancer/)
- technologies: [IMRT / IGRT (modern external beam)](https://onco.cc/technologies/imrt-igrt/)
- drugs: [Epacadostat](https://onco.cc/drugs/epacadostat/)
- companies: [Incyte](https://onco.cc/companies/incyte/)
- terms: [Colorectal cancer trials open today (registry snapshot)](https://onco.cc/terms/colorectal-trials-open-today/)

---
JSON: https://onco.cc/api/v1/entities/nct03516708.json