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.
Adults >= 18 years of age
Histologically confirmed high-risk NMIBC (T1, high-grade Ta, or carcinoma in situ [CIS]/Tis). Mixed histologies are allowed if predominantly transitional cell histology. Archival tissue or planned cystoscopy within 28 day of planned initiation of treatment
Maximally resected tumor on study entry
Cystectomy ineligible or declined
Patients with a prior or concurrent malignancy whose natural history or treatment may, in the opinion of the investigator, have the potential to interfere with the safety or efficacy assessment of the investigational regimen
Uncontrolled concomitant disease that in the opinion of the investigator would interfere with the patient's safety or compliance on trial
Known history of positive test for human immunodeficiency virus (HIV) with CD4 < 200 or acquired immunodeficiency syndrome (AIDS)-defining condition
Known active tuberculosis
Single group
PD-L1/IDO Peptide Vaccine
Biological/VaccineGiven SC
Pembrolizumab
Biological/VaccineGiven IV
Incidence of adverse events
Safety and toxicity will be evaluated according to Common Terminology Criteria for Adverse Events version 5.0 and pre-defined treatment-limiting toxicities.
Complete response (CR)
The CR rate will be estimated as the proportion of participants who experience an objective response, along with its exact 95% confidence interval. The CR rate at 3 months will be used to determine whether the trial will be expanded based on Simon's two-stage design.
Event-free survival
Kaplan-Meier methods will be used to estimate event-free (including recurrence on biopsy, development of muscle-invasive urothelial carcinoma, progression requiring radical cystectomy, or development of metastatic disease) survival at 18 months, along with 95% confidence intervals.
Cystectomy-free survival
Kaplan-Meier methods will also be used to estimate cystectomy-free survival at 18 months, along with 95% confidence intervals.
Duration of response (DOR)
DOR will be analyzed using Kaplan-Meier methods; medians and 95% confidence intervals will be computed.
Click on the lead sponsor to view all of their trials.
University of California, Davis
Lead sponsor
IO Biotech
Collaborator
National Cancer Institute (NCI)
Collaborator
