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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: Active Phase 2 study of Colorectal Carcinoma and Lynch Syndrome, sponsored by National Cancer Institute (NCI).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Will be compared between the two arms using a stratified Cochran-Mantel-Haenszel test where the randomization stratification factors will be included as strata. The cumulative events rates will be reported for each study arm along with the corresponding two-sided 95% confidence intervals.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 186 participants |
| Start Date | 2023-05-08 |
| Est. Completion | 2028-01-01 |
| Phase | Phase 2 |
What the registry record for NCT05419011 still lists
NCT05419011 is an interventional study that assigns participants to a tested intervention. The registered 186 participants enrollment target is mid-sized for trials with a published cap, below the 1,093-participant average among 53 other Colorectal Carcinoma trials with a reported enrollment target (83% lower).
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 lists 14 locations in 12 states (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.
Learn More About Clinical Trials
Similar trials for Colorectal Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05419011's enrollment target sits among peer trials
186 18th of 53 higher than 36 of 53 other Colorectal Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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