Melanoma
Conditions
Keywords
Pembrolizumab, Coxsackievirus A21, melanoma, CAVATAK, CVA21, checkpoint inhibitor
Brief 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.
Interventions
BIOLOGICALCAVATAK
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.
DRUGPembrolizumab
Intravenous pembrolizumab at 2 mg/kg solution.
Sponsors
Viralytics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with metastatic or unresectable stage IIIb/c of IV melanoma for whom treatment with pembrolizumab is indicated and who have at least one cutaneous, subcutaneous tumor or palpable lymph node amenable to intratumoral injection. * At least one tumor must qualify to be an index lesion for modified WHO criteria. * Subjects must have adequate hematologic, hepatic and renal function. * ECOG performance status of 0 or 1. * Anticipated lifespan greater than 12 weeks
Exclusion criteria
* Ocular primary tumors. * Presence of any central nervous system tumor that has not been stable for at least 4 weeks off corticosteroids. * Tumors lying in mucosal regions or close to an airway, major blood vessel or spinal cord. * Subjects with active, known or suspected autoimmune or immunosuppressive disease. * Subjects previously treated with CVA21. * Subjects requiring systemic treatment with corticosteroids or other immunosuppressive medications within 14 days prior to the first treatment. * Subject has received chemotherapy within the last 4 weeks prior to first treatment. * Clinically significant cardiovascular disease. * Females of childbearing potential must have negative serum or urine pregnancy test. * Subjects requiring or using other investigational agents while on treatment in this trial. * History of other malignancy within the last 3 years (with exceptions). * Active infection requiring systemic therapy. * Known history of HIV disease, active hepatitis B or hepatitis C. * History or evidence of other clinically significant disorders that would pose a risk to subject safety. * Inability to give informed consent and comply with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of dose-limiting toxicities (DLT) of intravenous pembrolizumab in combination with intratumoral CAVATAK will be assessed using CTCAE v. 4.0. | Up to 2 years |
Countries
United States
Outcome results
None listed