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CAVATAK and PembRolizumab in Advanced Melanoma (CAPRA)

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by Viralytics
Sponsor:
Information provided by (Responsible Party):
Viralytics
ClinicalTrials.gov Identifier:
NCT02565992
First received: September 30, 2015
Last updated: August 18, 2017
Last verified: August 2017
  Purpose
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 Intervention Phase
Melanoma Biological: CAVATAK Drug: Pembrolizumab Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Viralytics:

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. [ Time Frame: Up to 2 years ]

Estimated Enrollment: 30
Study Start Date: October 2015
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02565992

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

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

Responsible Party: Viralytics
ClinicalTrials.gov Identifier: NCT02565992     History of Changes
Other Study ID Numbers: VLA-011
Study First Received: September 30, 2015
Last Updated: August 18, 2017

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

ClinicalTrials.gov processed this record on September 19, 2017