Intratumoral CAVATAK (CVA21) and Pembrolizumab in Patients With Advanced Melanoma (VLA-011 CAPRA) (CAPRA)
January 12, 2023 updated by: Viralytics
Phase I Study of Intratumoral CAVATAK® (Coxsackievirus A21) and Pembrolizumab in Subjects With Advanced Melanoma (VLA-011 CAPRA)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Santa Monica, California, United States, 90404
- John Wayne Cancer Institute
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New Jersey
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New Brunswick, New Jersey, United States, 08901
- Rutgers Cancer Institute of New Jersey
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Ohio
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Canton, Ohio, United States, 44718
- Gabrail Cancer Center Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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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 Names:
Intravenous pembrolizumab at 2 mg/kg solution.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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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
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Up to 2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 17, 2015
Primary Completion (Actual)
November 4, 2019
Study Completion (Actual)
November 4, 2019
Study Registration Dates
First Submitted
September 30, 2015
First Submitted That Met QC Criteria
September 30, 2015
First Posted (Estimate)
October 1, 2015
Study Record Updates
Last Update Posted (Estimate)
January 16, 2023
Last Update Submitted That Met QC Criteria
January 12, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- V937-007
- VLA-011 (Other Identifier: Viralytics Study ID)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.