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NCT05843448 · ClinicalTrials.gov registry record · Phase 1
IDO and PD-L1 Peptide Based Immune-Modulatory Therapeutic (IO102-IO103) in Combination With Pembrolizumab for BCG-Unresponsive or Intolerant, Non-Muscle Invasive Bladder Cancer
A Phase 1 study of Stage 0a Bladder Cancer AJCC v8 and Stage I Bladder Cancer AJCC v8, sponsored by University of California, Davis.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT05843448: Recruiting Phase 1 study of Stage 0a Bladder Cancer AJCC v8 and Stage I Bladder Cancer AJCC v8, sponsored by University of California, Davis.
NCT05843448 is a Phase 1 study of Stage 0a Bladder Cancer AJCC v8 and Stage I Bladder Cancer AJCC v8 that is actively recruiting participants, run by University of California, Davis. The registered enrollment target is 30 participants, below the 242-participant average among 7 other Stage 0a Bladder Cancer AJCC v8 trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05843448, a Phase 1 study of Stage 0a Bladder Cancer AJCC v8 and Stage I Bladder Cancer AJCC v8, is actively recruiting participants, sponsored by University of California, Davis.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial tests the safety and side effects of a PD-L1/IDO peptide vaccine (IO102-IO103) in combination with pembrolizumab in treating patients with non-muscle invasive bladder cancer. IO102-IO103 is a novel IDO and PD-L1 peptide based immune-modulatory therapeutic. It is designed to activate the patient's own immune cells (called T-cells) to fight the tumor and stop the tumor cells escaping from the body's immune system. IO102-IO103 works to directly kill tumor cells and remove the body's immune suppressive cells, which are cells that prevent the immune system from fighting the tumor. 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 IO102-IO103 in combination with pembrolizumab may make tumor cells more visible/recognizable to the immune system.
Primary Outcome
Safety and toxicity will be evaluated according to Common Terminology Criteria for Adverse Events version 5.0 and pre-defined treatment-limiting toxicities.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- BIOLOGICAL PD-L1/IDO Peptide Vaccine
Study Locations (1)
California
- University of California Davis Comprehensive Cancer Center - Sacramento
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-04-19 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
What NCT05843448 shows while recruiting
NCT05843448 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 242-participant average among 7 other Stage 0a Bladder Cancer AJCC v8 trials with a reported enrollment target (88% lower).
The record links to 4 conditions, with Stage 0a Bladder Cancer AJCC v8 appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT05843448 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05843448 about?
NCT05843448 is a clinical study titled "IDO and PD-L1 Peptide Based Immune-Modulatory Therapeutic (IO102-IO103) in Combination With Pembrolizumab for BCG-Unresponsive or Intolerant, Non-Muscle Invasive Bladder Cancer". This phase I trial tests the safety and side effects of a PD-L1/IDO peptide vaccine (IO102-IO103) in combination with pembrolizumab in treating patients with non-muscle invasive bladder cancer. IO102-IO103 is a novel IDO and PD-L1 peptide based immune-modulatory therapeutic. It is designed to activa...
What is the current status of trial NCT05843448?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2023-04-19. Estimated completion is 2026-12.
What conditions does trial NCT05843448 study?
This clinical trial studies the following conditions: Stage 0a Bladder Cancer AJCC v8, Stage I Bladder Cancer AJCC v8, Stage 0is Bladder Cancer AJCC v8, High Risk Non-Muscle Invasive Bladder Urothelial Carcinoma.
What interventions are being tested in trial NCT05843448?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), PD-L1/IDO Peptide Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT05843448?
This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05843448 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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