Actively Recruiting
Pilot Study of an IDO and PD-L1 Peptide Vaccine (IO102-IO103) 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
26 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
Researchers are evaluating the safety and side effects of a combination treatment using a PD-L1/IDO peptide vaccine (IO102-IO103) alongside pembrolizumab in patients with non-muscle invasive bladder cancer who are unresponsive or intolerant to Bacillus Calmette-Guerin (BCG) therapy. This phase I trial explores how this novel immune-modulating vaccine may activate the body's T-cells to target tumors and counteract immune system suppression, potentially making tumor cells more recognizable to the immune system. Participants receive the PD-L1/IDO peptide vaccine through subcutaneous injections and pembrolizumab via intravenous infusion. During the study, patients undergo imaging scans such as computed tomography (CT) and/or CT/positron emission tomography (PET), as well as blood sample collections. After completing treatment, patients are followed for 30 days initially, then every three months for ongoing monitoring. Throughout the trial, researchers assess adverse events up to 30 days after the last dose, and measure outcomes like complete response at 3 months, event-free and cystectomy-free survival at 18 months, and duration of response up to 3 years. The study involves regular evaluations including imaging and blood tests to track safety and treatment effects, with a total participation period extending beyond treatment completion through follow-up visits.
CONDITIONS
Brief 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)
- Mixed histologies allowed if predominantly transitional cell histology
- Tumor maximally resected at study entry
- Ineligible for or declined cystectomy surgery
- 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 above 1000 cells/uL within 14 days before first treatment
- Platelet count above 50,000/uL within 14 days before first treatment
- Hemoglobin level above 8 g/dL within 14 days before first treatment
- Liver enzymes (AST/SGOT and ALT/SGPT) at or below 5 times the upper limit of normal within 14 days before first treatment
- Alkaline phosphatase at or below 5 times the upper limit of normal within 14 days before first treatment
- Total bilirubin at or below 2 times the upper limit of normal within 14 days before first treatment
- Creatinine clearance above 30 mL/min within 14 days before first treatment
- INR or aPTT at or below 1.5 times the upper limit of normal unless on anticoagulant therapy with therapeutic range
- Ability to understand and sign informed consent
- Ability to comply with study visits and protocol requirements
- Agreement to use contraception if of childbearing potential
You will not qualify if you...
- Prior or concurrent malignancy that may interfere with safety or efficacy assessment
- Uncontrolled diseases that interfere with safety or compliance
- Known HIV infection with CD4 count below 200 or AIDS-defining condition
- Active tuberculosis
- 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
- Any prior cancer therapy adverse events not resolved to grade 1 or less
- Severe congestive heart failure or unstable heart conditions
- Medical conditions requiring systemic steroids above prednisone 10 mg daily or immunosuppressive therapy within 14 days before treatment
- Live or live-attenuated vaccine within 30 days before first dose
- Pregnant or breastfeeding women
- Active interstitial lung disease or history of non-infectious pneumonitis needing steroids
- Allergy or reaction to components of study drugs
- Conditions preventing informed consent or safe participation
- Any condition judged by investigator to interfere with safety or compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants receive PD-L1/IDO peptide vaccine subcutaneously and pembrolizumab intravenously. Imaging scans and blood samples are collected throughout this period.
Visits for vaccine and pembrolizumab administration and assessments throughout treatment
Duration - 30 days and then every 3 months thereafter
After completing treatment, participants are followed up for safety and efficacy monitoring.
Regular follow-up visits every 3 months after initial 30-day visit
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
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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