Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 2

Testing a Combination of Vaccines for Cancer Prevention in Lynch Syndrome

NCT05419011 · View on ClinicalTrials.gov ↗

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)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05419011

The ClinicalTrials.gov registry entry for NCT05419011 describes a study currently listed as active not recruiting. It is categorized as Phase 2, 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 186 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. 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: NCT05419011 reports 14 study locations spanning 12 distinct geographic areas — top geographies include Arizona, Ohio, California. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05419011?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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