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Peptide Vaccine

Pembrolizumab + Vaccine for Bladder Cancer

Phase 1

Recruiting

Research Sponsored by Mamta Parikh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cystectomy ineligible or declined

ECOG (Eastern Cooperative Oncology Group) performance status score of 0 - 2

Must not have

Known active tuberculosis

Previous treatment with checkpoint inhibitors targeting either PD-(L)1 or CTLA-4

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a novel vaccine designed to boost the body's own immune system to fight bladder cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include typical reactions related to immunotherapy such as fatigue, flu-like symptoms, allergic reactions, skin rash or itching. There might also be specific effects from activating the immune system like inflammation in various organs which could lead to symptoms depending on which organs are affected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I cannot or do not want to undergo bladder removal surgery.

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I am able to get out of my bed or chair and move around.

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I have undergone two rounds of BCG therapy.

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My tumor has been fully removed through surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have active tuberculosis.

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I have been treated with drugs targeting PD-(L)1 or CTLA-4.

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I have previously been treated with IO102 or IO103.

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Side effects from my previous cancer treatments are mild or gone.

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I have or had lung inflammation not caused by infection, treated with steroids.

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I do not have severe heart issues like recent heart attacks or uncontrolled heart rhythm problems.

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I do not have an infection that needs treatment with medication.

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I have HIV with a CD4 count below 200 or an AIDS-defining condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events

Secondary study objectives

Complete response (CR)

Cystectomy-free survival

Duration of response (DOR)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (IO102-IO103, pembrolizumab)Experimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

0 / 12Eligibility criteria met