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

Part of paid clinical trials in Miami Beach, Florida.

Sponsor
Viralytics
Study ID
NCT03408587
Phase
PHASE1
Status
Completed

Conditions

  • Liver Metastases
  • Uveal Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 29, 2018
Status verified
May 2023
Primary completion
May 22, 2019
Completion
May 22, 2019

Study Design

Enrollment
11 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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).

Primary Outcome Measure

Incidence of treatment-related adverse events as assessed using the current NCI-CTCAE. [ Time Frame: 30 days from the last administration of study treatment ]

Locations (3)

FacilityCityStateZIPSite coordinators
Mount Sinai Medical CenterMiami BeachFlorida33140-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-

Find similar trials in Miami Beach, FL

By research site
Mount Sinai Medical Center· Miami Beach, FLDana-Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MA

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