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PD-L1/IDO Peptide Vaccine

Phase 1

High Risk Non-Muscle Invasive Bladder Urothelial Carcinoma | Monoclonal antibody | Oncology |IO Biotech, Inc.|Last Updated: Mar 13, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

PD-L1/IDO Peptide Vaccine · 1 trial · 4 indications

Phase 1 1
NCT05843448IDO and PD-L1 Peptide Based Immune-Modulatory Therapeutic (IO102-IO103) in Combination With Pembrolizumab for BCG-Unresponsive or Intolerant, Non-Muscle Invasive Bladder CancerHigh Risk Non-Muscle Invasive Bladder Urothelial Carcinoma
RECRUITING30 Analytics
PHASE1RECRUITING
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
High Risk Non-Muscle Invasive Bladder Urothelial CarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of adverse events
Up to 30 days after last dose

Safety and toxicity will be evaluated according to Common Terminology Criteria for Adverse Events version 5.0 and pre-defined treatment-limiting toxicities.

Secondary Endpoints

Complete response (CR)
At 3 months
Event-free survival
At 18 months
Cystectomy-free survival
At 18 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment (IO102-IO103, pembrolizumab)EXPERIMENTALPatients 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.

Interventions

NameTypeDescription
PD-L1/IDO Peptide VaccineBIOLOGICALGiven SC
PembrolizumabBIOLOGICALGiven IV
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * 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...

Countries:United States
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Frequently asked questions about PD-L1/IDO Peptide Vaccine

What is PD-L1, PD-L2 peptides with Montanide ISA51 used for?

PD-L1, PD-L2 peptides with Montanide ISA51 is an investigational peptide vaccine being studied for high risk non-muscle invasive bladder urothelial carcinoma and chronic lymphocytic leukemia. It is also known as PD-L1/IDO Peptide Vaccine and is developed by IO Biotech, Inc. (IOBT).

What does PD-L1, PD-L2 peptides with Montanide ISA51 target?

PD-L1, PD-L2 peptides with Montanide ISA51 targets PD-L1 and PD-L2, which are immune checkpoint proteins. By vaccinating against these targets, the therapy aims to stimulate an immune response against cancer cells that express these proteins.

Who makes PD-L1, PD-L2 peptides with Montanide ISA51?

PD-L1, PD-L2 peptides with Montanide ISA51 is developed by IO Biotech, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker IOBT. The company is conducting clinical trials to evaluate the vaccine in oncology indications.

What phase is PD-L1, PD-L2 peptides with Montanide ISA51 in?

PD-L1, PD-L2 peptides with Montanide ISA51 is in Phase 2 clinical development. It is investigational and not yet approved by regulatory authorities. The vaccine is being studied in patients with high risk non-muscle invasive bladder cancer and chronic lymphocytic leukemia.

What clinical trials is PD-L1, PD-L2 peptides with Montanide ISA51 in?

PD-L1, PD-L2 peptides with Montanide ISA51 has been studied in two clinical trials. NCT03939234, a completed Phase 2 trial in chronic lymphocytic leukemia, enrolled 19 patients in Denmark. NCT05843448, a recruiting Phase 1 trial, is evaluating the vaccine with pembrolizumab in non-muscle invasive bladder cancer in the United States.

Is PD-L1, PD-L2 peptides with Montanide ISA51 the same as PD-L1/IDO Peptide Vaccine?

Yes, PD-L1, PD-L2 peptides with Montanide ISA51 is also known as PD-L1/IDO Peptide Vaccine. The alternative name reflects the vaccine's inclusion of IDO peptides, which are being studied for their immune-modulatory effects in cancer treatment.