OncoMatch/Clinical Trials/NCT05843448
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
Is NCT05843448 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including PD-L1/IDO Peptide Vaccine and Pembrolizumab for high risk non-muscle invasive bladder urothelial carcinoma.
Treatment: PD-L1/IDO Peptide Vaccine · Pembrolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Urothelial Carcinoma
Disease stage
Required: Stage HIGH-GRADE TA, CIS, TIS (AJCC v8)
Grade: high-grade
Histologically confirmed high-risk NMIBC (T1, high-grade Ta, or carcinoma in situ [CIS]/Tis)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: BCG
Two induction courses of BCG attempted, regardless of exact doses received
Cannot have received: checkpoint inhibitor
Previous treatment with checkpoint inhibitors targeting either PD-(L)1 or CTLA-4
Cannot have received: IO102 (IO102)
Prior exposure to IO102
Cannot have received: IO103 (IO103)
Prior exposure to IO103
Cannot have received: systemic chemotherapy
Received systemic chemotherapy ... ≤ 2 weeks before study treatment initiation
Cannot have received: targeted small molecule therapy
Received ... targeted small molecule therapy ... ≤ 2 weeks before study treatment initiation
Cannot have received: radiotherapy
Received ... radiotherapy ≤ 2 weeks before study treatment initiation
Lab requirements
Blood counts
ANC > 1000 cells/uL; Platelet count > 50,000/uL; Hemoglobin > 8 g/dL (≤ 14 days of the first study treatment)
Kidney function
Creatinine clearance > 30 mL/min as measured using Cockcroft-Gault equation or eGFR from MDRD Study (≤ 14 days of the first study treatment)
Liver function
AST/SGOT, ALT/SGPT ≤ 5 x ULN; Alkaline phosphatase ≤ 5 x ULN; Total bilirubin ≤ 2 x ULN (≤ 14 days of the first study treatment)
ANC > 1000 cells/uL; Platelet count > 50,000/uL; Hemoglobin > 8 g/dL; AST/SGOT, ALT/SGPT ≤ 5 x ULN; Alkaline phosphatase ≤ 5 x ULN; Total bilirubin ≤ 2 x ULN; Creatinine clearance > 30 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California Davis Comprehensive Cancer Center · Sacramento, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05843448 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior checkpoint inhibitor, IO102, IO103 disqualifies patients from enrollment.
What disease stage is eligible?
Stage HIGH-GRADE TA or CIS or TIS is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages