30 Participants Needed

Pembrolizumab + Vaccine for Bladder Cancer

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on systemic steroids or immunosuppressive therapy, you may need to stop or adjust them before starting the trial. It's best to discuss your specific medications with the trial team.

Is the combination of Pembrolizumab and a vaccine generally safe for humans?

Pembrolizumab, also known as Keytruda, has been used in treating bladder cancer and is generally considered safe, but it can cause immune-related side effects like asthma. It has been approved by the FDA for certain types of bladder cancer, indicating a recognized safety profile.12345

What makes the pembrolizumab and vaccine treatment for bladder cancer unique?

This treatment combines pembrolizumab, an immune checkpoint inhibitor that helps the immune system attack cancer cells, with a PD-L1/IDO peptide vaccine, which is designed to enhance the immune response specifically against bladder cancer. This combination aims to improve the effectiveness of pembrolizumab by boosting the body's immune response to the cancer.13567

What data supports the effectiveness of the drug pembrolizumab for bladder cancer?

Research shows that pembrolizumab, an immune checkpoint inhibitor, has improved survival in bladder cancer patients and has shown efficacy in patients with high-risk nonmuscle-invasive bladder cancer that is unresponsive to other treatments.168910

Who Is on the Research Team?

Mamta Parikh, M.D., M.S. for UC Davis ...

Mamta Parikh

Principal Investigator

University of California, Davis

Are You a Good Fit for This Trial?

Adults over 18 with high-risk non-muscle invasive bladder cancer who've tried BCG treatment twice without success and aren't eligible for or have declined cystectomy. They should be in relatively good health (ECOG score 0-2) with a life expectancy of at least 6 months, adequate organ function, and no severe concurrent diseases. Pregnant women, those with certain recent treatments or vaccinations, uncontrolled diseases, or known allergies to trial drugs are excluded.

Inclusion Criteria

I cannot or do not want to undergo bladder removal surgery.
Your blood platelet count is above 50,000 per microliter within 14 days of starting the study treatment.
Your white blood cell count is not too low.
See 14 more

Exclusion Criteria

I have active tuberculosis.
I haven't had chemotherapy, targeted therapy, or radiotherapy in the last 2 weeks.
I have been treated with drugs targeting PD-(L)1 or CTLA-4.
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PD-L1/IDO peptide vaccine subcutaneously and pembrolizumab intravenously. Patients also undergo CT and/or CT/PET and collection of blood samples throughout the trial.

Up to 30 days after last dose

Follow-up

Participants are monitored for safety and effectiveness after treatment. Follow-up occurs every 3 months after the initial 30-day post-treatment period.

3 years

What Are the Treatments Tested in This Trial?

Interventions

  • PD-L1/IDO Peptide Vaccine
  • Pembrolizumab
Trial Overview The trial is testing the combination of an immune-modulatory therapeutic called IO102-IO103 with pembrolizumab against bladder cancer. IO102-IO103 aims to activate T-cells to fight tumors and remove cells that suppress the immune system. Pembrolizumab may help the body's immune system attack cancer by making tumor cells more visible to it.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment (IO102-IO103, pembrolizumab)Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mamta Parikh

Lead Sponsor

Trials
7
Recruited
210+

University of California, Davis

Lead Sponsor

Trials
958
Recruited
4,816,000+

IO Biotech

Industry Sponsor

Trials
9
Recruited
750+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

In a study of 39 patients with muscle-invasive bladder cancer, the combination of gemcitabine, cisplatin, and the immune checkpoint inhibitor pembrolizumab was effective, achieving pathologic downstaging in 56% of patients and complete pathologic response in 36%.
The treatment was generally safe, with common side effects including thrombocytopenia, anemia, and neutropenia, but no severe immune-related adverse events were reported, indicating a manageable safety profile for this neoadjuvant therapy.
Phase II Study of Gemcitabine and Split-Dose Cisplatin Plus Pembrolizumab as Neoadjuvant Therapy Before Radical Cystectomy in Patients With Muscle-Invasive Bladder Cancer.Rose, TL., Harrison, MR., Deal, AM., et al.[2022]
Pembrolizumab, an immune checkpoint inhibitor, showed a strong antitumor effect in a 70-year-old female patient with unresectable bladder cancer, but it also led to a grade 3 asthma attack as an immune-related adverse event.
The patient's asthma was linked to changes in immune cell markers, specifically increased CTLA-4 and TIM-3 in CD4+ T cells and a rise in Th17 cells, suggesting that these immune responses could be indicators of both adverse effects and treatment efficacy.
A case of bronchial asthma as an immune-related adverse event of pembrolizumab treatment for bladder cancer: A case report.Hamada, K., Yoshimura, K., Oshinomi, K., et al.[2022]
In a phase 3 study involving 487 patients with advanced urothelial carcinoma, the combination of pembrolizumab and lenvatinib did not show improved progression-free survival (4.5 months) or overall survival (11.8 months) compared to pembrolizumab with placebo.
The combination treatment resulted in a higher rate of severe adverse events (51%) compared to the placebo group (27%), leading to the conclusion that the benefit-to-risk ratio was not favorable for using lenvatinib with pembrolizumab as first-line therapy.
Pembrolizumab with or Without Lenvatinib as First-line Therapy for Patients with Advanced Urothelial Carcinoma (LEAP-011): A Phase 3, Randomized, Double-Blind Trial.Matsubara, N., de Wit, R., Balar, AV., et al.[2023]

Citations

Phase II Study of Gemcitabine and Split-Dose Cisplatin Plus Pembrolizumab as Neoadjuvant Therapy Before Radical Cystectomy in Patients With Muscle-Invasive Bladder Cancer. [2022]
A case of bronchial asthma as an immune-related adverse event of pembrolizumab treatment for bladder cancer: A case report. [2022]
Pembrolizumab with or Without Lenvatinib as First-line Therapy for Patients with Advanced Urothelial Carcinoma (LEAP-011): A Phase 3, Randomized, Double-Blind Trial. [2023]
KEYNOTE-676: Phase III study of BCG and pembrolizumab for persistent/recurrent high-risk NMIBC. [2020]
TAS0313 Plus Pembrolizumab for Post-Chemotherapy Immune Checkpoint Inhibitor-Naïve Locally Advanced or Metastatic Urothelial Carcinoma. [2023]
Safety and activity of pembrolizumab in patients with locally advanced or metastatic urothelial cancer (KEYNOTE-012): a non-randomised, open-label, phase 1b study. [2022]
Successful pembrolizumab treatment in a patient with metastatic urothelial carcinoma and underlying overlap syndrome involving systemic sclerosis and systemic lupus erythematosus. [2022]
Association of Immune-Related Adverse Events with Pembrolizumab Efficacy in the Treatment of Advanced Urothelial Carcinoma. [2020]
FDA Approves Pembrolizumab for BCG-Unresponsive NMIBC. [2021]
Pembrolizumab in the treatment of advanced urothelial cancer. [2018]
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