Trials / Completed
CompletedNCT02307149
Intratumoral CAVATAK (CVA21) and Ipilimumab in Patients With Advanced Melanoma (VLA-013 MITCI)
A PHASE 1b STUDY OF INTRATUMORAL CAVATAK® (COXSACKIEVIRUS A21, CVA21) AND IPILIMUMAB IN PATIENTS WITH ADVANCED MELANOMA (VLA-013 MITCI)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Viralytics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Open label, single arm study of intratumoral CVA21 and ipilimumab in advanced melanoma patients.
Detailed description
Primary Objective: To evaluate the safety and efficacy of CAVATAK (CVA21) administered intratumorally in combination with the approved dose and schedule of ipilimumab. Of particular interest is to estimate the overall response rate (ORR) in the subgroup of subjects with unresectable or metastatic stage III B/C or IV melanoma who have progressed on a single prior anti-PD-1 therapy. Secondary Objectives: 1. Assess the clinical efficacy of ipilimumab in combination with intratumoral CVA21 in terms of: * Immune-related progression-free survival (irPFS) at 6 and 12 months, * Durable response rate (DRR), * 1-year survival, * Overall survival (OS), and * Quality of life. 2. Assess the response of injected and non-injected melanoma lesions after CVA21 and ipilimumab. 3. Assess the time to initial response.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CAVATAK | CAVATAK is a preparation of CVA21 |
| DRUG | Ipilimumab | Ipilimumab is a human cytotoxic T-lymphocyte antigen (CTLA-4)-blocking antibody indicated for the treatment of unresectable or metastatic melanoma |
Timeline
- Start date
- 2015-05-05
- Primary completion
- 2019-11-05
- Completion
- 2019-11-05
- First posted
- 2014-12-04
- Last updated
- 2023-01-17
Locations
11 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02307149. Inclusion in this directory is not an endorsement.