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NCT05419011 · ClinicalTrials.gov registry record · Phase 2

Testing a Combination of Vaccines for Cancer Prevention in Lynch Syndrome

A Phase 2 study of Colorectal Carcinoma and Lynch Syndrome, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 2
Development phase
186
Enrollment target
14
Study locations

NCT05419011 is a Phase 2 study of Colorectal Carcinoma and Lynch Syndrome that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 186 participants, below the 1,093-participant average among 53 other Colorectal Carcinoma trials with a reported enrollment target (83% lower). The trial reports 14 study locations across 12 states.

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The verdict

NCT05419011, a Phase 2 study of Colorectal Carcinoma and Lynch Syndrome, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
186 participants
Enrollment target
14
Study locations

Study Summary

This phase IIb trial tests whether Tri-Ad5 in combination with N-803 works to prevent colon and other cancers in participants with Lynch syndrome. Each of the three injections in Tri-Ad5 vaccine contain a different substance that is in precancer and cancer cells. Injecting these substances may cause the immune system to develop a defense against cancer that recognizes and destroys any precancer and cancer cells that produce these proteins in the future. N-803 may increase immune responses to other vaccines. Giving Tri-Ad5 in combination with immune enhancing N-803 may lower the chance of developing colon and other cancers in participants with Lynch syndrome.

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Colonoscopy
  • PROCEDURE Biopsy Procedure
  • BIOLOGICAL Adenovirus 5 CEA/MUC1/Brachyury Vaccine Tri-Ad5
  • DRUG Nogapendekin Alfa

Study Locations (14)

Arizona

  • Mayo Clinic Hospital in Arizona - Phoenix
  • University of Arizona Cancer Center - Prevention Research Clinic - Tucson

Ohio

  • Cleveland Clinic Foundation - Cleveland
  • Ohio State University Comprehensive Cancer Center - Columbus

California

  • UCSF Medical Center-Parnassus - San Francisco

Colorado

  • University of Colorado - Denver

Illinois

  • Northwestern University - Chicago

Kansas

  • University of Kansas Cancer Center - Kansas City

Massachusetts

  • Dana-Farber Cancer Institute - Boston

Michigan

  • University of Michigan Rogel Cancer Center - Ann Arbor

Trial Details

FieldValue
Enrollment Target 186 participants
Start Date 2023-05-08
Est. Completion 2028-01-01
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT05419011

The ClinicalTrials.gov registry entry for NCT05419011 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 186 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,093-participant average among 53 other Colorectal Carcinoma trials with a reported enrollment target (83% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Colorectal Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT05419011 reports 14 study locations spanning 12 distinct geographic areas - top geographies include Arizona, Ohio, California.

Frequently Asked Questions

What is clinical trial NCT05419011 about?

NCT05419011 is a clinical study titled "Testing a Combination of Vaccines for Cancer Prevention in Lynch Syndrome". This phase IIb trial tests whether Tri-Ad5 in combination with N-803 works to prevent colon and other cancers in participants with Lynch syndrome. Each of the three injections in Tri-Ad5 vaccine contain a different substance that is in precancer and cancer cells. Injecting these substances may cause...

What is the current status of trial NCT05419011?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 186 participants. The study started on 2023-05-08. Estimated completion is 2028-01-01.

What conditions does trial NCT05419011 study?

This clinical trial studies the following conditions: Colorectal Carcinoma, Lynch Syndrome, Colorectal Neoplasm.

What interventions are being tested in trial NCT05419011?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Colonoscopy (PROCEDURE), Biopsy Procedure (PROCEDURE), Adenovirus 5 CEA/MUC1/Brachyury Vaccine Tri-Ad5 (BIOLOGICAL), Nogapendekin Alfa (DRUG).

Who is sponsoring clinical trial NCT05419011?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05419011 being conducted?

This trial has 14 study locations across Arizona, California, Colorado, Illinois, Kansas. 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 Editorial

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.