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

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ClinicalTrials.gov Identifier: NCT02565992
Recruitment Status : Recruiting
First Posted : October 1, 2015
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
Viralytics

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.

Condition or disease Intervention/treatment Phase
Melanoma Biological: CAVATAK Drug: Pembrolizumab Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Intratumoral CAVATAK® (Coxsackievirus A21) and Pembrolizumab in Subjects With Advanced Melanoma (VLA-011 CAPRA)
Study Start Date : October 2015
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Arm Intervention/treatment
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.
Biological: 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.
Other Name: Coxsackievirus A21, CVA21
Drug: Pembrolizumab
Intravenous pembrolizumab at 2 mg/kg solution.



Primary Outcome Measures :
  1. 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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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02565992


Contacts
Contact: Leslie Guerreiro Leslie.Guerriero@Viralytics.com

Locations
United States, California
John Wayne Cancer Institute Recruiting
Santa Monica, California, United States, 90404
Principal Investigator: Steven O'Day, MD         
United States, New Jersey
Rutgers Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08901
Principal Investigator: Ann Silk, MD         
United States, Ohio
Gabrail Cancer Center Research Recruiting
Canton, Ohio, United States, 44718
Contact: Carrie L Smith, RN         
Principal Investigator: Nashat Gabrail, MD         
Sponsors and Collaborators
Viralytics

Responsible Party: Viralytics
ClinicalTrials.gov Identifier: NCT02565992     History of Changes
Other Study ID Numbers: VLA-011
First Posted: October 1, 2015    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018

Keywords provided by Viralytics:
Pembrolizumab
Coxsackievirus A21
melanoma
CAVATAK
CVA21
checkpoint inhibitor

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Pembrolizumab
Antineoplastic Agents