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Checkpoint Inhibitor
Lerapolturev + Anti-PD-1/L1 for Bladder Cancer
Phase 1 & 2
Waitlist Available
Research Sponsored by Istari Oncology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years of age at the time of signing the informed consent
Adequate bone marrow and liver function as assessed by specific criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights
Study Summary
This trial is for people with solid tumors who will be given lerapolturev, a new cancer treatment, ± anti-PD-1/L1 therapy. This study is open-label, meaning that both the participants and the researchers know what treatment is being given, and single arm, meaning that everyone in the study will receive the same treatment.
Who is the study for?
Adults with advanced solid tumors, specifically non-muscle invasive bladder cancer, who can consent and comply with study requirements. They must be vaccinated against poliovirus, have measurable disease per RECIST 1.1 criteria, adequate organ function, ECOG status of 0 or 1, and use approved contraception methods. Exclusions include recent cancer treatments or surgeries, CNS metastases needing urgent treatment, significant heart issues or autoimmune diseases.Check my eligibility
What is being tested?
The trial is testing Lerapolturev alone and in combination with anti-PD-1/L1 therapy in patients with advanced solid tumors to evaluate safety and effectiveness. It's an open-label basket study where all participants receive the experimental treatment without a comparison group.See study design
What are the potential side effects?
Potential side effects may include typical reactions to immunotherapies such as fatigue, flu-like symptoms (fever/chills), injection site reactions; immune-related adverse events like inflammation of organs; allergic reactions due to drug components; plus any specific risks associated with lerapolturev.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My bone marrow and liver are functioning well.
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I can provide a tumor sample with a report on its type for the study.
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I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of patients who undergo TURBT or cystectomy as scheduled
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort F: Lerapolturev + 5% DDMExperimental Treatment2 Interventions
Subjects will be treated with lerapolturev by intravesical instillation after a sequence of 5% DDM and saline washes
Group II: Cohort E: LerapolturevExperimental Treatment1 Intervention
Subjects will be treated with lerapolturev by intravesical instillation
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Who is running the clinical trial?
Istari Oncology, Inc.Lead Sponsor
12 Previous Clinical Trials
404 Total Patients Enrolled
Lisa FranklinStudy DirectorIstari Oncology
1 Previous Clinical Trials
30 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had an autoimmune disease or immune deficiency in the past 2 years.I have a history of agammaglobulinemia.I haven't had cancer treatment like chemo or radiation in the last 21 days.I need urgent treatment for cancer spread to my brain.I am 18 years old or older.My bone marrow and liver are functioning well.I have had a stem cell or bone marrow transplant.I am legally unable to make my own medical decisions.Your heart's electrical activity is measured to be too slow or too fast.My condition is not non-muscle invasive bladder cancer.I have had brain or nerve problems from a PV infection.I need warfarin for blood thinning.I have a history of specific lung conditions or signs of lung inflammation on a CT scan.I haven't had major surgery or a serious injury in the last 28 days.I've had all recommended polio vaccines and a recent IPOL booster.You have a tumor that can be measured using specific guidelines for evaluating cancer.My side effects from previous treatments are mild or gone, except for hair loss.I have bladder cancer that has not spread into the muscle layer.I can provide a tumor sample with a report on its type for the study.I have not received any live vaccines in the last 28 days.I haven't taken any immune-weakening drugs in the last 28 days.I have heart problems that currently affect my health.You have had an allergic reaction to human serum albumin in the past.I am fully active or can carry out light work.I do not have any serious active infections like HIV, hepatitis B or C, or tuberculosis.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort E: Lerapolturev
- Group 2: Cohort F: Lerapolturev + 5% DDM
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.
How many participants have enrolled in the clinical trial thus far?
"To initiate the clinical trial, 15 suitable participants are required. Patients can register to take part at Virginia Oncology Associates in Hampton or Cancer Treatment Centers of America situated in Newnan, Georgia - among other sites."
Answered by AI
How many healthcare facilities are conducting this research trial?
"At present, 21 different trial sites are accepting participants for this medical study. Selecting the nearest clinic is encouraged to lessen travel requirements and these areas include Hampton, Newnan and Lake Success in addition to 18 other cities."
Answered by AI
Is this research still open to enrolling new participants?
"Clinicaltrials.gov divulges that this trial, which was initially announced on August 1st 2021, is presently in need of participants. The study's most recent update took place on July 8th 2022."
Answered by AI
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