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

NCT02565992 | Completed Phase 1

• 2 other identifiers: V937-007VLA-011
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

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.

Conditions

Melanoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

CAVATAK and pembrolizumab

EXPERIMENTAL

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; Drug: Pembrolizumab

Interventions

CAVATAK BIOLOGICAL

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.

Also known as: Coxsackievirus A21, CVA21

CAVATAK and pembrolizumab

Pembrolizumab DRUG

Intravenous pembrolizumab at 2 mg/kg solution.

CAVATAK and pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Viralytics: lead

Study Sites (3)

John Wayne Cancer Institute

Santa Monica, California, 90404, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Gabrail Cancer Center Research

Canton, Ohio, 44718, United States

Location

Related Publications (1)

• Silk AW, O'Day SJ, Kaufman HL, Bryan J, Norrell JT, Imbergamo C, Portal D, Zambrano-Acosta E, Palmeri M, Fein S, Wu C, Guerreiro L, Medina D, Bommareddy PK, Zloza A, Fox BA, Ballesteros-Merino C, Ren Y, Shafren D, Grose M, Vieth JA, Mehnert JM. A phase 1b single-arm trial of intratumoral oncolytic virus V937 in combination with pembrolizumab in patients with advanced melanoma: results from the CAPRA study. Cancer Immunol Immunother. 2023 Jun;72(6):1405-1415. doi: 10.1007/s00262-022-03314-1. Epub 2022 Nov 29.

  PMID: 36445410 RESULT

MeSH Terms

Conditions

Melanoma

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2015
• First Posted: October 1, 2015
• Study Start: December 17, 2015
• Primary Completion: November 4, 2019
• Study Completion: November 4, 2019
• Last Updated: January 17, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share

Locations

US (3)