NCT03408587

CAVATAK® and Ipilimumab in Uveal Melanoma Metastatic to the Liver (VLA-024 CLEVER)

An Open-Label Phase 1b Clinical Study of Intravenous CAVATAK® (Coxsackievirus A21, CVA21), in Combination With Ipilimumab in Subjects With Uveal Melanoma Metastatic to Liver (VLA-024 CLEVER)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Viralytics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. Subjects will receive up to 8 cycles of CVA21 at a planned dose of 1 x 10e9 TCID50 per infusion, with the first cycle being a 28-day cycle consisting of an intravenous infusion on Days 1, 3, 5 and 8 and subsequent cycles every 21 days from Day 8. Ipilimumab will be given by intravenous administration at a dose of 3mg/kg, for a maximum of 4 doses, given on Days 8, 29, 50 and 71. On days when both CVA21 and ipilimumab are given, CVA21 will be given first. Subjects will be monitored for treatment toxicity using the current version of CTCAE.

Conditions

• Uveal Melanoma
• Liver Metastases

Interventions

Type	Name	Description
BIOLOGICAL	CVA21	Oncolytic virus
BIOLOGICAL	Ipilimumab	Fully human IgG1 monoclonal antibody that binds to the CTLA-4 receptor expressed on activated T cells.

Timeline

• Start date: 2018-01-29
• Primary completion: 2019-05-22
• Completion: 2019-05-22
• First posted: 2018-01-24
• Last updated: 2023-05-06

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study