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Virus Therapy
CAVATAK® and Ipilimumab in Uveal Melanoma Metastatic to the Liver (VLA-024 CLEVER) (CLEVER Trial)
Phase 1
Waitlist Available
Led By Jose Lutzky, MD
Research Sponsored by Viralytics
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 2 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This is an open-label Phase 1b clinical study of ipilimumab in combination with intravenous CVA21 in subjects who have uveal melanoma metastatic to liver.
Eligible Conditions
- Uveal Melanoma
- Liver Metastases
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of treatment-related adverse events as assessed using the current NCI-CTCAE.
Secondary study objectives
Overall Response Rate
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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: CVA21 / IpilimumabExperimental Treatment2 Interventions
Subjects will receive up to 8 cycles (Day 155) of intravenous CVA21 and 4 doses of ipilimumab (Days 8, 29, 50 and 71).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CVA21
2008
Completed Phase 2
~60
Ipilimumab
FDA approved
Find a Location
Who is running the clinical trial?
ViralyticsLead Sponsor
11 Previous Clinical Trials
295 Total Patients Enrolled
Jose Lutzky, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
3 Previous Clinical Trials
2,061 Total Patients Enrolled