MelanomaPhase 1CAPRANCT02565992
Intratumoral CAVATAK (CVA21) and Pembrolizumab in Patients With Advanced Melanoma (VLA-011 CAPRA)
A Phase 1 study testing CAVATAK and Pembrolizumab in people with Melanoma, run by Viralytics at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- CAVATAK and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Dec 2015to 4 Nov 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Gabrail Cancer Center Research
Canton, Ohio, 44718
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
John Wayne Cancer Institute
Santa Monica, California, 90404
About this study
Official title: 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.
- Conditions
- Melanoma
- Being tested
- CAVATAK, Pembrolizumab
- Keywords
- Pembrolizumab, Coxsackievirus A21, melanoma, CAVATAK, CVA21, checkpoint inhibitor
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAVATAKBiological
Also called Coxsackievirus A21, CVA21
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.
PembrolizumabDrug
Intravenous pembrolizumab at 2 mg/kg solution.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: CAVATAK; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of dose-limiting toxicities (DLT) of intravenous pembrolizumab in combination with intratumoral CAVATAK will be assessed using CTCAE v. 4.0.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study start17 Dec 2015
- Primary completion4 Nov 2019
- Study completion4 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viralytics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02565992
- Sponsor's protocol ID
- V937-007
- Other IDs
- VLA-011
- Acronym
- CAPRA
- Status last verified
- Jan 2023
- First submitted
- 30 Sep 2015
- Last updated
- 17 Jan 2023
- Results posted
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Publications
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.
PubMed 36445410
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Intratumoral CAVATAK® (Coxsackievirus A21) and Pembrolizumab in Subjects With Advanced Melanoma (VLA-011 CAPRA)
- ClinicalTrials.gov ID
- NCT02565992
- Acronym / sponsor ID
- CAPRA / V937-007
- Conditions
- Melanoma
- Keywords
- Pembrolizumab, Coxsackievirus A21, melanoma, CAVATAK, CVA21, checkpoint inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- ViralyticsIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2015 (actual)
- Primary completion
- 4 Nov 2019 (actual)
- Study completion
- 4 Nov 2019 (actual)
- First posted
- 1 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAVATAK and pembrolizumab | Experimental | Biological: CAVATAK, Drug: PembrolizumabIntratumoral 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAVATAKAlso: Coxsackievirus A21, CVA21Maximum 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. | Biological | CAVATAK and pembrolizumab |
| PembrolizumabIntravenous pembrolizumab at 2 mg/kg solution. | Drug | CAVATAK and pembrolizumab |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
- Results publication: PubMed 36445410Silk 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.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CAVATAK and Pembrolizumab in people with Melanoma, run by Viralytics at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02565992, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2023; AzTrials last refreshed its copy on 8 Nov 2026.