Actively Recruiting
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
Led by University of California, Davis · Updated on 2026-03-13
30
Participants Needed
1
Research Sites
188 weeks
Total Duration
On this page
Sponsors
U
University of California, Davis
Lead Sponsor
I
IO Biotech
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older
- Histologically confirmed high-risk non-muscle invasive bladder cancer (T1, high-grade Ta, or carcinoma in situ/Tis), with predominantly transitional cell histology
- Tumor has been maximally resected before study entry
- Patient is ineligible for or has declined cystectomy
- At least two induction courses of Bacillus Calmette-Guerin (BCG) attempted
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
- Life expectancy of 6 months or more
- Absolute neutrophil count greater than 1000 cells/uL within 14 days before first study treatment
- Platelet count greater than 50,000/uL within 14 days before first study treatment
- Hemoglobin level greater than 8 g/dL within 14 days before first study treatment
- Liver enzymes (AST/ALT) less than or equal to 5 times the upper limit of normal within 14 days before first study treatment
- Alkaline phosphatase less than or equal to 5 times the upper limit of normal within 14 days before first study treatment
- Total bilirubin less than or equal to 2 times the upper limit of normal within 14 days before first study treatment
- Creatinine clearance greater than 30 mL/min within 14 days before first study treatment
- International normalized ratio (INR) or activated partial thromboplastin time (aPTT) less than or equal to 1.5 times upper limit of normal, or within therapeutic range if on anticoagulants
- Ability to understand and sign informed consent
- Willingness and ability to comply with study visits and protocol
- Agreement to use contraception if of childbearing potential
You will not qualify if you...
- Prior or concurrent malignancy that may interfere with treatment safety or efficacy assessment
- Uncontrolled diseases that could affect safety or compliance
- Known HIV infection with CD4 count below 200 or AIDS-defining conditions
- Active tuberculosis infection
- Active infection requiring systemic therapy, including active or difficult urinary tract infection
- Previous treatment with checkpoint inhibitors targeting PD-(L)1 or CTLA-4
- Prior exposure to IO102 or IO103
- Systemic chemotherapy, targeted therapy, or radiotherapy within 2 weeks before study treatment
- Unresolved adverse events from previous cancer therapy above grade 1
- Significant heart conditions including congestive heart failure (NYHA III or IV), unstable angina, serious arrhythmia, recent myocardial infarction, or myocarditis
- Use of systemic steroids over prednisone 10 mg daily or immunosuppressive therapy within 14 days before first dose
- Live or live-attenuated vaccine within 30 days before first dose
- Pregnant or breastfeeding women
- Active interstitial lung disease or history of pneumonitis requiring systemic steroids
- Allergy to any component of study drugs
- Inability to understand or provide informed consent
- Any condition that may interfere with safety or compliance during the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
Research Team
O
Office of Clinical Research
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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