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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I cannot or do not want to undergo bladder removal surgery.
Select...
I am able to get out of my bed or chair and move around.
Select...
I have undergone two rounds of BCG therapy.
Select...
My tumor has been fully removed through surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Secondary outcome measures
Complete response (CR)
Cystectomy-free survival
Duration of response (DOR)
+1 moreTrial 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 2
~2010
Find a Location
Who is running the clinical trial?
Mamta ParikhLead Sponsor
6 Previous Clinical Trials
180 Total Patients Enrolled
University of California, DavisLead Sponsor
911 Previous Clinical Trials
4,709,489 Total Patients Enrolled
IO BiotechIndustry Sponsor
8 Previous Clinical Trials
749 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I have previously been treated with IO102 or IO103.Side effects from my previous cancer treatments are mild or gone.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.I have or had lung inflammation not caused by infection, treated with steroids.I do not have severe heart issues like recent heart attacks or uncontrolled heart rhythm problems.You are expected to live for at least 6 more months.I am able to get out of my bed or chair and move around.I haven't had a live vaccine within the last 30 days.I have undergone two rounds of BCG therapy.I am not on high doses of steroids or immunosuppressants, but stable on thyroid or adrenal replacement therapy.My bladder cancer is high-risk but not muscle-invasive.I am 18 years old or older.My tumor has been fully removed through surgery.Your hemoglobin level needs to be above 8 grams per deciliter within 14 days of starting the study treatment.Your liver enzymes (AST and ALT) are not more than 5 times the normal limit.Your alkaline phosphatase level is not more than 5 times the upper limit of normal within 14 days before starting the study treatment.My kidney function is good, with a creatinine clearance rate over 30 mL/min.My blood clotting tests are normal or managed if I'm on blood thinners.You have had or currently have another type of cancer that could affect the safety or effectiveness of the study treatment.I do not have an infection that needs treatment with medication.I agree to use birth control during the study.I have HIV with a CD4 count below 200 or an AIDS-defining condition.Your total bilirubin level must be within a certain range.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (IO102-IO103, pembrolizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available openings for participants in this clinical investigation?
"This medical study, whose initial posting was logged on June 1st 2023 and final update occurred on April 24th 2023, is no longer seeking participants. Fortunately, there are 331 other trials currently open for enrollment."
Answered by AI
Has the administration granted approval for Treatment (IO102-IO103, pembrolizumab)?
"Considering the limited supporting data, our team at Power has cautiously rated the safety of Treatment (IO102-IO103, pembrolizumab) with a score of 1."
Answered by AI
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