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

Primary Purpose

Melanoma

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

CAVATAK

Pembrolizumab

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Pembrolizumab, Coxsackievirus A21, melanoma, CAVATAK, CVA21, checkpoint inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

John Wayne Cancer Institute
Rutgers Cancer Institute of New Jersey
Gabrail Cancer Center Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CAVATAK and pembrolizumab

Arm Description

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.

Outcomes

Primary Outcome Measures

The incidence of dose-limiting toxicities (DLT) of intravenous pembrolizumab in combination with intratumoral CAVATAK will be assessed using CTCAE v. 4.0.

Secondary Outcome Measures

Full Information

NCT ID

NCT02565992

First Posted

September 30, 2015

Last Updated

January 12, 2023

Sponsor

Viralytics

1. Study Identification

Unique Protocol Identification Number

NCT02565992

Brief Title

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

Acronym

CAPRA

Official Title

Phase I Study of Intratumoral CAVATAK® (Coxsackievirus A21) and Pembrolizumab in Subjects With Advanced Melanoma (VLA-011 CAPRA)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

December 17, 2015 (Actual)

Primary Completion Date

November 4, 2019 (Actual)

Study Completion Date

November 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Viralytics

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CAVATAK and pembrolizumab

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

CAVATAK

Other Intervention Name(s)

Coxsackievirus A21, CVA21

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Pembrolizumab

Intervention Description

Intravenous pembrolizumab at 2 mg/kg solution.

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

John Wayne Cancer Institute

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Facility Name

Rutgers Cancer Institute of New Jersey

City

New Brunswick

State/Province

New Jersey

ZIP/Postal Code

08901

Country

United States

Facility Name

Gabrail Cancer Center Research

City

Canton

State/Province

Ohio

ZIP/Postal Code

44718

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

IPD Sharing URL

http://engagezone.msd.com/ds_documentation.php

Citations:

PubMed Identifier

36445410

Citation

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.

Results Reference

result

Learn more about this trial

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

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