Actively Recruiting
Epacadostat (INCB024360) Added to Preoperative Chemoradiation in Patients With Locally Advanced Rectal Cancer
Led by Washington University School of Medicine · Updated on 2026-02-11
49
Participants Needed
4
Research Sites
553 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
I
Incyte Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Epacadostat (INCB024360) Added to Preoperative Chemoradiation in Patients With Locally Advanced Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed locally advanced rectal cancer (AJCC stage 2 or 3, or stage 1 not eligible for sphincter-sparing surgery) with planned total neoadjuvant short course radiation
- Age 18 years or older
- ECOG performance status of 0, 1, or 2
- Adequate bone marrow and organ function: neutrophils 1.5 K/cumm, platelets 100 K/cumm, hemoglobin > 9 g/dL, bilirubin 1.5 x upper limit normal, AST/ALT 2.5 x upper limit normal, creatinine < 1.5 x upper limit normal or creatinine clearance 50 mL/min/1.73 m2
- Willing to undergo study-related biopsies if applicable and safe (Washington University and Dana Farber Cancer Institute only)
- Agree to contraceptive methods during study and for 120 days after last treatment (women of childbearing potential and men)
- Able to understand and willing to sign informed consent
You will not qualify if you...
- Prior anti-cancer therapy for rectal cancer
- Previous treatment with IDO pathway targeting agents including indoximod
- Prior pelvic radiotherapy, prior rectal surgery, or investigational treatment for rectal cancer within 1 month
- Presence or suspicion of another malignancy that could interfere with study assessments
- Current use of other investigational agents
- Extensive tumor growth into upper sacrum or lumbosacral nerve roots making surgery impossible
- Metastatic disease or recurrent rectal tumor
- Diagnosis of Familial Adenomatosis Polyposis coli, Hereditary Non-Polyposis Colorectal Cancer, active Crohn's disease, or active ulcerative colitis
- History of allergic reactions to epacadostat, pembrolizumab, 5-FU, oxaliplatin, or related agents
- Active infection requiring systemic therapy
- Current use of warfarin
- History of serotonin syndrome after serotonergic drugs
- Uncontrolled illnesses such as active tuberculosis, pneumonitis needing treatment, symptomatic heart failure, unstable angina, or arrhythmia
- Active or recent autoimmune disease requiring systemic treatment within 2 years
- Abnormal screening ECG deemed clinically significant
- Gastrointestinal conditions affecting drug absorption
- Receipt of live attenuated vaccine within 30 days before treatment
- Pregnant or breastfeeding
- Known active hepatitis B or C infection
- Microsatellite instability-high or mismatch repair deficient rectal cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
University of California Irvine - Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Withdrawn
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
Henry Ford Cancer Institute
Detroit, Michigan, United States, 48202
Withdrawn
4
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
M
Moh'd Khushman, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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