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Checkpoint Inhibitor
Lerapolturev With or Without Immune Therapy for Melanoma
Phase 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new cancer drug to see if it is effective and safe when used alone or with another cancer drug.
Who is the study for?
This trial is for adults with advanced melanoma that has worsened despite treatment with FDA-approved anti-PD-1/L1 therapy. Participants must be in good physical condition, not have certain types of melanoma or severe diseases, and agree to use contraception. They should also be willing to undergo tumor biopsies.
What is being tested?
The study is testing lerapolturev alone or combined with an anti-PD-1 checkpoint inhibitor to see how effective and safe they are for treating melanoma that hasn't responded to previous PD-1 inhibitors.
What are the potential side effects?
Potential side effects may include typical immune-related reactions such as inflammation in various organs, flu-like symptoms, fatigue, skin reactions at the injection site, and possibly others depending on individual health conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes from baseline in PD-L1 expression
Neoplasms
Frequency and severity of adverse events of special interest (AESIs and AEs)
+3 moreSecondary study objectives
DCR-6 months
Disease Control Rate
Durable Response Rate
+3 moreOther study objectives
DCR based on iRECIST
DCR based on subgroup
DCR-6mo based on iRECIST
+10 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm 2: Lerapolturev and anti-PD-1Experimental Treatment2 Interventions
Lerapolturev (up to 1.6x10\^9 TCID50) administered via direct injection of up to 6 lesions given weekly for 7 weeks, followed by every 3 or 4 weeks thereafter. Anti-PD-1 therapy given as per the anti-PD-1 approved package insert.
Group II: Arm 1: Lerapolturev OnlyExperimental Treatment1 Intervention
Lerapolturev (up to 1.6x10\^9 TCID50) administered via direct injection of up to 6 lesions given weekly for 7 weeks, followed by every 3 weeks thereafter.
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Who is running the clinical trial?
Istari Oncology, Inc.Lead Sponsor
12 Previous Clinical Trials
347 Total Patients Enrolled
2 Trials studying Melanoma
12 Patients Enrolled for Melanoma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You need to take medication to prevent blood clots and cannot stop taking it for a few days before and after receiving each lerapolturev injection.You have or had an autoimmune disease or a weakened immune system within the past 2 years.If you're not sure if you got the vaccine, you need to show evidence that you are protected against the disease before joining the study.You have at least two melanoma growths that can be measured by a ruler or imaging tests according to specific guidelines.You have received a transplant with someone else's cells or organs in the past.You have melanoma that affects specific parts of the body such as the eyes, palms of the hands, soles of the feet, or mucous membranes.You have a medical condition that would make it unsafe or difficult for you to participate in the study, or make it hard to accurately measure the study's outcomes.You are expected to live for at least 12 more weeks.You have pain that is not being managed by current treatments and is caused by the tumor.You have cancerous growths that can be treated with palliative radiation therapy and are currently causing symptoms.You have a serious heart condition.You have had an allergic reaction to human serum albumin in the past.You have a history of neurological problems caused by polio virus infection.You are allergic to pembrolizumab or nivolumab, or any of the other ingredients in these drugs.You are 18 years old or older.If you had a tumor biopsy within the last 4 months, and have not received any anti-cancer treatment since then, you may be able to use that same biopsy for this study.You had cancer in the past two years before the start of the trial.You had a serious infection within the last 4 weeks before the trial starts.You must have at least one lesion that can be safely biopsied without significant risk. Lesions in high-risk areas like the brain, lung, pancreas, and certain parts of the digestive tract may not be eligible for biopsy.You must have at least one melanoma lesion that is visible or can be felt, and it must be at least 10 mm in size. Alternatively, you can have multiple lesions that can be injected, as long as they add up to at least 10 mm in size and the smallest lesion is at least 5 mm in size.You have received a recommended vaccine against PV (poliovirus) and received a booster shot of trivalent IPOL® (made by Sanofi-Pasteur SA) between 1 to 6 weeks before the start of the study.You have melanoma that cannot be surgically removed and are willing to have a biopsy before and during the study.You cannot participate if your cancer has spread to multiple distant parts of your body (M1c or M1d disease).
Research Study Groups:
This trial has the following groups:- Group 1: Arm 2: Lerapolturev and anti-PD-1
- Group 2: Arm 1: Lerapolturev Only
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.
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