Intratumoral CAVATAK (CVA21) and Ipilimumab in Patients With Advanced Melanoma (VLA-013 MITCI)

Part of paid clinical trials in Duarte, California.

Sponsor
Viralytics
Study ID
NCT02307149
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • CAVATAK — BIOLOGICAL
    CAVATAK is a preparation of CVA21
  • Ipilimumab — DRUG
    Ipilimumab is a human cytotoxic T-lymphocyte antigen (CTLA-4)-blocking antibody indicated for the treatment of unresectable or metastatic melanoma

Study Details

Open label, single arm study of intratumoral CVA21 and ipilimumab in advanced melanoma patients.

Key Dates

Start date
May 5, 2015
Status verified
Jan 2023
Primary completion
Nov 5, 2019
Completion
Nov 5, 2019

Study Design

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

Arms

  • Experimental: CAVATAK and ipilimumab
    CAVATAK intratumoral injection up to a total dose of 3 x 10⁸ TCID50 and ipilimumab intravenously at the recommended dose of 3 mg/kg

Primary Outcome Measure

Response [ Time Frame: 106 days ]

Locations (11)

FacilityCityStateZIPSite coordinators
City of Hope National Medical Center,DuarteCalifornia91010-
UC San Diego Moores Cancer CenterLa JollaCalifornia92093-
The Angeles Clinic & Research InstituteLos AngelesCalifornia90025-
John Wayne Cancer InstituteSanta MonicaCalifornia90404-
Sylvester Comprehensive Cancer CenterMiamiFlorida33136-
Advocate Health, SCPark RidgeIllinois60068-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Atlantic Melanoma CenterMorristownNew Jersey07960-
Providence Portland Medical CenterPortlandOregon97213-
Huntsman Cancer InstituteSalt Lake CityUtah84112-

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