CAVATAK® and Ipilimumab in Uveal Melanoma Metastatic to the Liver (VLA-024 CLEVER) (CLEVER)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03408587|
Recruitment Status : Completed
First Posted : January 24, 2018
Last Update Posted : June 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Uveal Melanoma Liver Metastases||Biological: CVA21 Biological: Ipilimumab||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Actual Study Start Date :||January 29, 2018|
|Actual Primary Completion Date :||May 22, 2019|
|Actual Study Completion Date :||May 22, 2019|
Experimental: CVA21 / Ipilimumab
Subjects will receive up to 8 cycles (Day 155) of intravenous CVA21 and 4 doses of ipilimumab (Days 8, 29, 50 and 71).
Other Name: CAVATAK, Coxsackievirus A21
Fully human IgG1 monoclonal antibody that binds to the CTLA-4 receptor expressed on activated T cells.
Other Name: Yervoy
- Incidence of treatment-related adverse events as assessed using the current NCI-CTCAE. [ Time Frame: 30 days from the last administration of study treatment ]Treatment-emergent adverse events (TEAEs) are defined as AEs that start on or after the first day of study treatment and within 30 days of the last administration of study treatment. The incidence of TEAEs will be summarized based on the number and percentage of subjects who experience events classified by MedDRA system organ class and preferred term.
- Overall Response Rate [ Time Frame: 2 years ]Objective responses will be assessed according to immune-related Response Evaluation Criteria In Solid Tumors (irRECIST) criteria
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03408587
|United States, Florida|
|Mount Sinai Medical Center|
|Miami Beach, Florida, United States, 33140|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Jose Lutzky, MD||Icahn School of Medicine at Mount Sinai|