RecruitingPhase 1Phase 2NCT03516708

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

Phase I/II Study of Epacadostat (INCB024360) Added to Preoperative Chemoradiation in Patients With Locally Advanced Rectal Cancer


Sponsor

Washington University School of Medicine

Enrollment

49 participants

Start Date

Jan 6, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether adding a drug called epacadostat (which helps the immune system fight cancer) to the standard pre-surgery chemoradiation treatment for locally advanced rectal cancer can improve outcomes. **You may be eligible if...** - You have been recently diagnosed with locally advanced rectal cancer (stage 2 or 3, or stage 1 not suitable for sphincter-sparing surgery) - You are planning to receive short-course radiation therapy before surgery - You are 18 years or older and in reasonably good health (ECOG score 0–2) - Your blood counts, liver, and kidney function are within acceptable ranges - You are using contraception if you could become pregnant or father a child **You may NOT be eligible if...** - You have not been newly diagnosed (prior chemotherapy for rectal cancer disqualifies you) - You are pregnant or planning to become pregnant - Your organ function is outside the required thresholds - You are unable to understand or sign a consent form Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEpacadostat

Drug provided.

RADIATIONShort-course radiation therapy

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

DRUGCAPOX chemotherapy

Standard of care

DRUGFOLFOX chemotherapy

Standard of care


Locations(4)

University of California Irvine - Chao Family Comprehensive Cancer Center

Orange, California, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Henry Ford Cancer Institute

Detroit, Michigan, United States

Washington University School of Medicine

St Louis, Missouri, United States

View Full Details on ClinicalTrials.gov

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NCT03516708


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