RecruitingRectal Cancer
Epacadostat (INCB024360) Added to Preoperative Chemoradiation in Patients With Locally Advanced Rectal Cancer
Eligible age
18+ yrs
Accepts
All genders
Locations
4 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: Washington University School of Medicine
You may qualify if…
- ✓ 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 treating physician
- ✓ At least 18 years of age.
- ✓ ECOG performance status 0, 1, or 2
- ✓ Adequate bone marrow and organ function as defined below:
- ✓ Absolute neutrophil count ≥ 1.5 K/cumm
- ✓ Platelets ≥ 100 K/cumm
- ✓ Hemoglobin \> 9 g/dL
- ✓ Total bilirubin ≤ 1.5 x IULN
You may not qualify if…
- ✕ Received prior anti-cancer therapy for rectal cancer.
- ✕ Prior treatment with agents targeting IDO pathway (including indoximod)
- ✕ Previous radiotherapy in the pelvic region or previous rectal surgery (e.g. TEM) or any investigational treatment for rectal cancer within the past month.
- ✕ Known or suspected presence of another malignancy that could be mistaken for the malignancy under study during disease assessments.
- ✕ Currently receiving any other investigational agents.
- ✕ Extensive growth into cranial part of the sacrum (above S3) or the lumbosacral nerve roots indicating that surgery will never be possible even if substantial tumor downsizing is seen.
- ✕ Presence of metastatic disease or recurrent rectal tumor.
- ✕ Diagnosis of Familial Adenomatosis Polyposis coli (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC), active Crohn's disease, or active ulcerative colitis.
Where it's recruiting
Source: ClinicalTrials.gov · NCT03516708 · last updated 2026-02-11