RecruitingPhase 1NCT05843448

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

Pilot Study of an 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


Sponsor

University of California, Davis

Enrollment

30 participants

Start Date

Apr 19, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a vaccine-like immunotherapy (IO102-IO103) combined with pembrolizumab (an immune checkpoint inhibitor) for people with non-muscle invasive bladder cancer that has not responded to BCG — a standard immune therapy given directly into the bladder. The combination aims to train the immune system to attack remaining cancer cells. **You may be eligible if...** - You are 18 or older - You have high-risk non-muscle invasive bladder cancer confirmed by biopsy - Your cancer did not respond to or you could not tolerate two courses of BCG treatment - You are not eligible for or have declined bladder removal surgery (cystectomy) - Your bladder tumor has been fully removed (maximally resected) and you are in reasonably good health **You may NOT be eligible if...** - Your bladder cancer has invaded the muscle wall (muscle-invasive disease) - You have an active autoimmune disease requiring systemic treatment - You have had prior treatment with pembrolizumab or similar checkpoint inhibitors - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALPD-L1/IDO Peptide Vaccine

Given SC

BIOLOGICALPembrolizumab

Given IV


Locations(1)

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05843448


Related Trials