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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-17

Study Completion Date

2019-11-04

Brief Summary

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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.

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Detailed Description

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Conditions

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Melanoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

CAVATAK

Intervention Type 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.

Pembrolizumab

Intervention Type DRUG

Intravenous pembrolizumab at 2 mg/kg solution.

Interventions

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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.

Intervention Type BIOLOGICAL

Pembrolizumab

Intravenous pembrolizumab at 2 mg/kg solution.

Intervention Type DRUG

Other Intervention Names

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Coxsackievirus A21, CVA21

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No