Trials / Completed
CompletedNCT02565992
Intratumoral CAVATAK (CVA21) and Pembrolizumab in Patients With Advanced Melanoma (VLA-011 CAPRA)
Phase I Study of Intratumoral CAVATAK® (Coxsackievirus A21) and Pembrolizumab in Subjects With Advanced Melanoma (VLA-011 CAPRA)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Viralytics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will employ a phase Ib design using the established dose of CAVATAK with pembrolizumab in subjects with advanced melanoma for whom pembrolizumab would be considered standard of care. Our hypothesis is that oncolysis of melanoma cells by CAVATAK will be important in amplifying the T-cell potentiating effects of pembrolizumab.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CAVATAK | Maximum dose of CVA21 is 3 x 10E+08 TCID50 (about 4.5 x 10E+06 TCID50/kg for a 70-kg patient) by intratumoral administration. |
| DRUG | Pembrolizumab | Intravenous pembrolizumab at 2 mg/kg solution. |
Timeline
- Start date
- 2015-12-17
- Primary completion
- 2019-11-04
- Completion
- 2019-11-04
- First posted
- 2015-10-01
- Last updated
- 2023-01-17
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02565992. Inclusion in this directory is not an endorsement.