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
NCT ID: NCT05843448
Last Updated: 2024-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
30 participants
INTERVENTIONAL
2023-04-19
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
SECONDARY OBJECTIVES: I. To assess preliminary efficacy of IO102-IO103 in combination with pembrolizumab. II. To obtain preliminary efficacy of IO102-IO103 in combination with pembrolizumab.
OUTLINE: Patients receive PD-L1/IDO peptide vaccine subcutaneously (SC) and pembrolizumab intravenously (IV) on study. Patients also undergo computed tomography (CT) and/or CT/positron emission tomography (PET) and collection of blood samples throughout the trial.After completion of study treatment, patients are followed up for 30 days and then every 3 months thereafter.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment (IO102-IO103, pembrolizumab)
Patients receive PD-L1/IDO peptide vaccine SC and pembrolizumab IV on study. Patients also undergo CT and/or CT/PET and collection of blood samples throughout the trial.
PD-L1/IDO Peptide Vaccine
Given SC
Pembrolizumab
Given IV
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PD-L1/IDO Peptide Vaccine
Given SC
Pembrolizumab
Given IV
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Two induction courses of BCG attempted, regardless of exact doses received
* ECOG (Eastern Cooperative Oncology Group) performance status score of 0 - 2
* Life expectancy \>= 6 months
* Absolute neutrophil count (ANC) \> 1000 cells/uL (=\< 14 days of the first study treatment)
* Platelet count \> 50,000/uL (=\< 14 days of the first study treatment)
* Hemoglobin \> 8 g/dL (=\< 14 days of the first study treatment)
* Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT)/serum glutamate pyruvate transaminase (SGPT) =\< 5 x upper limit of normal (ULN) (=\< 14 days of the first study treatment)
* Alkaline phosphatase =\< 5 x upper limit of normal (ULN) (=\< 14 days of the first study treatment)
* Total bilirubin =\< 2 x ULN (=\< 14 days of the first study treatment)
* Creatinine clearance \> 30 mL/min as measured using Cockcroft-Gault equation or the estimated glomerular filtration rate from the Modification of Diet in Renal Disease Study (=\< 14 days of the first study treatment)
* International normalized ratio (INR) or activated partial thromboplastin time (aPTT) =\< 1.5 X ULN unless the subject is receiving anticoagulant therapy. Individuals on anticoagulant therapy should have a prothrombin time (PT) or partial thromboplastin time (PTT) within therapeutic range of intended use and no history of severe hemorrhage
* Ability to understand and willingness to sign an informed consent document
* Ability to adhere to the study visit schedule and other protocol requirements
* For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use methods of contraception
Exclusion Criteria
* 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
* Active infection requiring systemic therapy, including active or intractable urinary tract infection (UTI)
* Previous treatment with checkpoint inhibitors targeting either PD-(L)1 or CTLA-4
* Prior exposure to IO102 or IO103
* Received systemic chemotherapy, targeted small molecule therapy, or radiotherapy =\< 2 weeks before study treatment initiation
* Any adverse events from prior cancer therapy have resolved to grade =\< 1 according to Common Terminology Criteria for Adverse Events (CTCAE) version 5
* Congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), unstable angina, serious uncontrolled cardiac arrhythmia, a myocardial infarction within 6 months prior to study entry or a history of myocarditis
* Any medical condition requiring systemic steroid equivalent to prednisone \> 10 mg daily or immunosuppressive therapy within 14 days or 5 half-lives prior to first dose of trial therapy. Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone are eligible. Patients who have adrenal insufficiency and hypophysitis from prior immunotherapy if they are on stable medical replacement doses are eligible
* Received a live or live-attenuated vaccine =\< 30 days before the first dose of study treatment. Administration of killed vaccines, messenger ribonucleic acid (mRNA) based vaccines (e.g., COVID-19), and vector based vaccines are allowed
* Pregnant and/or breast feeding women. If a urine pregnancy test is positive or cannot be confirmed as negative, a serum pregnancy test will be required =\< 24 hours prior to planned treatment initiation
* Evidence of active interstitial lung disease or history of non-infectious pneumonitis requiring systemic steroids
* Known allergy or reaction to any component of either study drug formulation
* Any condition that would prohibit the understanding or rendering of informed consent
* Any condition that in the opinion of the investigator would interfere with the patient's safety or compliance while on trial
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
IO Biotech
INDUSTRY
National Cancer Institute (NCI)
NIH
University of California, Davis
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mamta Parikh
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mamta Parikh
Role: PRINCIPAL_INVESTIGATOR
University of California, Davis
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Mamta Parikh
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2023-02851
Identifier Type: REGISTRY
Identifier Source: secondary_id
UCDCC#290
Identifier Type: OTHER
Identifier Source: secondary_id
UCDCC#290
Identifier Type: -
Identifier Source: org_study_id