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NCT05130060 · ClinicalTrials.gov registry record · Phase 1
A Vaccine (PolyPEPI1018 Vaccine) and TAS-102 for the Treatment of Metastatic Colorectal Cancer
A Phase 1 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT05130060: Completed Phase 1 study, sponsored by Mayo Clinic.
NCT05130060 is a Phase 1 study that has completed, run by Mayo Clinic. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05130060, a Phase 1 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
This phase Ib trial studies the safety and side effects of a vaccine (PolyPEPI1018 vaccine) in combination with TAS-102 in treating patients with colorectal that has spread to other parts of the body (metastatic). PolyPEPI1018 peptide vaccine is used to immunize against proteins present on the surface of tumor cells. This vaccine can activate the body's immune cells, called T cells. T cells fight infections and can also kill cancer cells. TAS-102 may help block the formation of growths that may become cancer. Giving PolyPEPI1018 and TAS-102 may kill more tumor cells in patients with metastatic colorectal cancer.
Primary Outcome
The occurrence of at least 1 Grade 4 local AE or 1 Grade 3+ systemic AE during the first cycle of treatment. Evaluable patients are patients who are eligible, consented, received at least 50% of their expected cycle 1 trifluridine and tipiracil hydrochloride treatment, and received at least one dose of the PolyPEPI1018 Vaccine. The final local or systemic AE rate point estimate and corresponding 95% confidence interval will be reported.
Interventions
- DRUG Trifluridine and Tipiracil Hydrochloride
- BIOLOGICAL Colorectal Cancer Peptide Vaccine PolyPEPI1018
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2022-01-10 |
| Est. Completion | 2023-06-11 |
| Phase | Phase 1 |
What the finished NCT05130060 record still lists
NCT05130060 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 2 interventions - of which Trifluridine and Tipiracil Hydrochloride is the first listed.
NCT05130060 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05130060 about?
NCT05130060 is a clinical study titled "A Vaccine (PolyPEPI1018 Vaccine) and TAS-102 for the Treatment of Metastatic Colorectal Cancer". This phase Ib trial studies the safety and side effects of a vaccine (PolyPEPI1018 vaccine) in combination with TAS-102 in treating patients with colorectal that has spread to other parts of the body (metastatic). PolyPEPI1018 peptide vaccine is used to immunize against proteins present on the surfa...
What is the current status of trial NCT05130060?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2022-01-10. Estimated completion is 2023-06-11.
What interventions are being tested in trial NCT05130060?
The interventions under investigation include: Trifluridine and Tipiracil Hydrochloride (DRUG), Colorectal Cancer Peptide Vaccine PolyPEPI1018 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05130060?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05130060's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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