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RECRUITING Phase 1

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

NCT03516708 · View on ClinicalTrials.gov ↗

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 Studied

Interventions

  • DRUG Epacadostat
  • RADIATION Short-course radiation therapy
  • DRUG CAPOX chemotherapy
  • DRUG FOLFOX chemotherapy

Study Locations (4)

California

  • University of California Irvine - Chao Family Comprehensive Cancer Center — Orange

Massachusetts

  • Dana Farber Cancer Institute — Boston

Michigan

  • Henry Ford Cancer Institute — Detroit

Missouri

  • Washington University School of Medicine — St Louis

Trial Details

FieldValue
Enrollment Target 49 participants
Start Date 2020-01-06
Est. Completion 2030-08-12
Phase Phase 1

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03516708

The ClinicalTrials.gov registry entry for NCT03516708 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,036 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Rectal Cancer appearing as the primary indexed condition, and to 4 interventions — of which Epacadostat is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03516708 reports 4 study locations spanning 4 distinct geographic areas — top geographies include California, Massachusetts, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03516708 about?

NCT03516708 is a clinical study titled "Epacadostat (INCB024360) Added to Preoperative Chemoradiation in Patients With Locally Advanced Rectal Cancer". 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.

What is the current status of trial NCT03516708?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2020-01-06. Estimated completion is 2030-08-12.

What conditions does trial NCT03516708 study?

This clinical trial studies the following conditions: Rectal Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03516708?

The interventions under investigation include: Epacadostat (DRUG), Short-course radiation therapy (RADIATION), CAPOX chemotherapy (DRUG), FOLFOX chemotherapy (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03516708?

This trial is sponsored by Washington University School of Medicine, which has 1,036 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03516708 being conducted?

This trial has 4 study locations across California, Massachusetts, Michigan, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial