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

NCT03516708 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2026-02-11

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Epacadostat

Drug provided.

RADIATION

Short-course radiation therapy

Short-course pelvic radiation therapy, 5 Gy x 5 fractions over 1 week

DRUG

CAPOX chemotherapy

Standard of care

DRUG

FOLFOX chemotherapy

Standard of care

Sponsors & Collaborators

  • Incyte Corporation

    collaborator INDUSTRY

  • National Cancer Institute (NCI)

    collaborator NIH

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Moh'd Khusman, M.D. · Washington University School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-06
Primary Completion
2027-07-15
Completion
2030-08-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03516708 on ClinicalTrials.gov