Intratumoral CAVATAK (CVA21) and Pembrolizumab in Patients With Advanced Melanoma (VLA-011 CAPRA) (CAPRA)

• ClinicalTrials.gov Identifier: NCT02565992
• Recruitment Status: Completed
• First Posted: October 1, 2015
• Last Update Posted: January 18, 2020
• Sponsor: Viralytics
• Information provided by (Responsible Party): Viralytics

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Melanoma	Biological: CAVATAK; Drug: Pembrolizumab	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 36 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm	Intervention/treatment
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.	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.; Other Name: Coxsackievirus A21, CVA21; Drug: Pembrolizumab; Intravenous pembrolizumab at 2 mg/kg solution.

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

Viralytics

More Information

• Responsible Party: Viralytics
• ClinicalTrials.gov Identifier: NCT02565992
• Other Study ID Numbers: V937-007; VLA-011 ( Other Identifier: Viralytics Study ID )
• First Posted: October 1, 2015
• Last Update Posted: January 18, 2020
• Last Verified: January 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
• URL: http://engagezone.msd.com/ds_documentation.php

Keywords provided by Viralytics:

Pembrolizumab; Coxsackievirus A21; melanoma; CAVATAK; CVA21; checkpoint inhibitor

Additional relevant MeSH terms:

Melanoma; Nevi and Melanomas; Pembrolizumab; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Antineoplastic Agents, Immunological; Antineoplastic Agents