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NCT04130854 · ClinicalTrials.gov registry record · Phase 2

INNATE: Immunotherapy During Neoadjuvant Therapy for Rectal Cancer

A Phase 2 study of Locally Advanced Rectal Adenocarcinoma, sponsored by University of Texas Southwestern Medical Center.

Active
Registry status
Phase 2
Development phase
58
Enrollment target
4
Study locations

NCT04130854 is a Phase 2 study of Locally Advanced Rectal Adenocarcinoma that is active but no longer recruiting, run by University of Texas Southwestern Medical Center. The registered enrollment target is 58 participants, below the 97-participant average among 5 other Locally Advanced Rectal Adenocarcinoma trials with a reported enrollment target (40% lower). The trial reports 4 study locations across 4 states.

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The verdict

NCT04130854, a Phase 2 study of Locally Advanced Rectal Adenocarcinoma, is active but no longer recruiting, sponsored by University of Texas Southwestern Medical Center.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
58 participants
Enrollment target
4
Study locations

Study Summary

Determine the complete pathologic complete response (pCR) rate in patients with locally advanced rectal adenocarcinoma.

Interventions

  • DRUG APX005M, mFOLFOX, and Radiation Therapy 5Gy x 5 days
  • DRUG mFOLFOX and Radiation Therapy 5Gy x 5 days

Study Locations (4)

Arizona

  • The University of Arizona Cancer Center - Tucson

North Carolina

  • Wake Forest Baptist Health Sciences - Winston-Salem

Oregon

  • Oregon Health & Science University - Portland

Texas

  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas - Dallas

Trial Details

FieldValue
Enrollment Target 58 participants
Start Date 2020-04-24
Est. Completion 2026-01-31
Phase Phase 2

What the Registry Record Tells You About NCT04130854

The ClinicalTrials.gov registry entry for NCT04130854 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 97-participant average among 5 other Locally Advanced Rectal Adenocarcinoma trials with a reported enrollment target (40% lower). The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Locally Advanced Rectal Adenocarcinoma appearing as the primary indexed condition, and to 2 interventions - of which APX005M, mFOLFOX, and Radiation Therapy 5Gy x 5 days is the first listed.

NCT04130854 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Arizona, North Carolina, Oregon.

Frequently Asked Questions

What is clinical trial NCT04130854 about?

NCT04130854 is a clinical study titled "INNATE: Immunotherapy During Neoadjuvant Therapy for Rectal Cancer". Determine the complete pathologic complete response (pCR) rate in patients with locally advanced rectal adenocarcinoma.

What is the current status of trial NCT04130854?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2020-04-24. Estimated completion is 2026-01-31.

What conditions does trial NCT04130854 study?

This clinical trial studies the following conditions: Locally Advanced Rectal Adenocarcinoma.

What interventions are being tested in trial NCT04130854?

The interventions under investigation include: APX005M, mFOLFOX, and Radiation Therapy 5Gy x 5 days (DRUG), mFOLFOX and Radiation Therapy 5Gy x 5 days (DRUG).

Who is sponsoring clinical trial NCT04130854?

This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04130854 being conducted?

This trial has 4 study locations across Arizona, North Carolina, Oregon, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.