Intratumoral CAVATAK (CVA21) and Pembrolizumab in Patients With Advanced Melanoma (VLA-011 CAPRA) (CAPRA)
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|ClinicalTrials.gov Identifier: NCT02565992|
Recruitment Status : Completed
First Posted : October 1, 2015
Last Update Posted : January 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Biological: CAVATAK Drug: Pembrolizumab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Intratumoral CAVATAK® (Coxsackievirus A21) and Pembrolizumab in Subjects With Advanced Melanoma (VLA-011 CAPRA)|
|Actual Study Start Date :||December 17, 2015|
|Actual Primary Completion Date :||November 4, 2019|
|Actual Study Completion Date :||November 4, 2019|
Experimental: CAVATAK and pembrolizumab
Intratumoral CAVATAK administration on trial days 1, 3, 5 and 8 and at 3-weekly intervals up to a maximum of 19 total with intravenous pembrolizumab (2 mg/kg solution) starting on day 8 and continuing every 3 weeks, up to 2 years.
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.
Other Name: Coxsackievirus A21, CVA21
Intravenous pembrolizumab at 2 mg/kg solution.
- The incidence of dose-limiting toxicities (DLT) of intravenous pembrolizumab in combination with intratumoral CAVATAK will be assessed using CTCAE v. 4.0. [ Time Frame: Up to 2 years ]
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): NCT02565992
|United States, California|
|John Wayne Cancer Institute|
|Santa Monica, California, United States, 90404|
|United States, New Jersey|
|Rutgers Cancer Institute of New Jersey|
|New Brunswick, New Jersey, United States, 08901|
|United States, Ohio|
|Gabrail Cancer Center Research|
|Canton, Ohio, United States, 44718|