OncoMatch/Clinical Trials/NCT03516708
Epacadostat (INCB024360) Added to Preoperative Chemoradiation in Patients With Locally Advanced Rectal Cancer
Is NCT03516708 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Epacadostat and CAPOX chemotherapy for rectal cancer.
Treatment: Epacadostat · CAPOX chemotherapy · FOLFOX chemotherapy — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Disease stage
Required: Stage II, III, I (AJCC 8th edition)
locally advanced rectal cancer (defined by 8th edition AJCC stage 2 or 3, or stage 1 not eligible for sphincter-sparing surgery)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: anti-cancer therapy
Received prior anti-cancer therapy for rectal cancer
Cannot have received: IDO pathway inhibitor (indoximod)
Prior treatment with agents targeting IDO pathway (including indoximod)
Cannot have received: radiation therapy
Previous radiotherapy in the pelvic region
Cannot have received: surgery
previous rectal surgery (e.g. TEM)
Cannot have received: investigational treatment
any investigational treatment for rectal cancer within the past month
Lab requirements
Blood counts
absolute neutrophil count ≥ 1.5 k/cumm; platelets ≥ 100 k/cumm; hemoglobin > 9 g/dl
Kidney function
serum creatinine < 1.5 x iuln or measured or calculated creatinine clearance ≥ 50 ml/min/1.73 m2
Liver function
total bilirubin ≤ 1.5 x iuln; ast(sgot)/alt(sgpt) ≤ 2.5 x iuln
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California Irvine - Chao Family Comprehensive Cancer Center · Orange, California
- Dana Farber Cancer Institute · Boston, Massachusetts
- Henry Ford Cancer Institute · Detroit, Michigan
- Washington University School of Medicine · St Louis, Missouri
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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