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NCT05269381 · ClinicalTrials.gov registry record · Phase 1
Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors
A Phase 1 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage IV Breast Cancer AJCC v8, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 132
- Enrollment target
- 1
- Study location
NCT05269381: Recruiting Phase 1 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage IV Breast Cancer AJCC v8, sponsored by Mayo Clinic.
NCT05269381 is a Phase 1 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage IV Breast Cancer AJCC v8 that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 132 participants, below the 303-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (56% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05269381, a Phase 1 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage IV Breast Cancer AJCC v8, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 132 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I/II trial tests the safety and tolerability of an experimental personalized vaccine when given by itself and with pembrolizumab in treating patients with solid tumor cancers that have spread to other places in the body (advanced). The experimental vaccine is designed target certain proteins (neoantigens) on individuals' tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving the personalized neoantigen peptide-based vaccine with pembrolizumab may be safe and effective in treating patients with advanced solid tumors.
Primary Outcome
MTD is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients (at least 2 of a maximum of 6 new patients). A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD. For instance, those toxicities with an incidence of at least 25% will be observed with a probability of at least 82% (1-(1-0.25).
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Cyclophosphamide
- PROCEDURE Biospecimen Collection
- BIOLOGICAL Sargramostim
- BIOLOGICAL Neoantigen Peptide Vaccine
Study Locations (1)
Florida
- Mayo Clinic in Florida - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2022-03-31 |
| Est. Completion | 2028-03-31 |
| Phase | Phase 1 |
What NCT05269381 shows while recruiting
NCT05269381 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, below the 303-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (56% lower).
The record links to 10 conditions, with Anatomic Stage III Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT05269381 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05269381 about?
NCT05269381 is a clinical study titled "Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors". This phase I/II trial tests the safety and tolerability of an experimental personalized vaccine when given by itself and with pembrolizumab in treating patients with solid tumor cancers that have spread to other places in the body (advanced). The experimental vaccine is designed target certain prote...
What is the current status of trial NCT05269381?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 132 participants. The study started on 2022-03-31. Estimated completion is 2028-03-31.
What conditions does trial NCT05269381 study?
This clinical trial studies the following conditions: Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8.
What interventions are being tested in trial NCT05269381?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Cyclophosphamide (DRUG), Biospecimen Collection (PROCEDURE), Sargramostim (BIOLOGICAL), Neoantigen Peptide Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT05269381?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05269381 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05269381's enrollment target sits among peer trials
132 30th of 84 higher than 55 of 84 other Anatomic Stage III Breast Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anatomic Stage III Breast Cancer AJCC v8 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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