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Trial record 1 of 1 for:    NCT02307149
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Study of Intratumoral CAVATAK™ (Coxsackievirus A21) and Ipilimumab in Patients With Advanced Melanoma

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by Viralytics
Sponsor:
Collaborator:
Providence Health & Services
Information provided by (Responsible Party):
Viralytics
ClinicalTrials.gov Identifier:
NCT02307149
First received: November 26, 2014
Last updated: April 20, 2017
Last verified: April 2017
  Purpose
The study will use the established dose of CAVATAK with ipilimumab in patients with advanced melanoma for whom ipilimumab would be considered standard of care. Treatment with CAVATAK will be on days 1, 3, 5 and 8 and then both agents will be co-administered on days 22, 43, 64 and 85. Patients with clinical benefit can continue CAVATAK every 3 weeks for up to one year,

Condition Intervention Phase
Melanoma Biological: CAVATAK Drug: Ipilimumab Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Phase Ib Study of Intratumoral CAVATAK™ (Coxsackievirus A21) and Ipilimumab in Patients With Advanced Melanoma

Resource links provided by NLM:


Further study details as provided by Viralytics:

Primary Outcome Measures:
  • Safety/ tolerance of multiple intratumoral injections of CAVATAK when given in conjunction with ipilimumab as assessed by incidence of dose-limiting toxicities (DLT). [ Time Frame: Up to 106 days ]

Secondary Outcome Measures:
  • Estimate the objective response rate to CAVATAK and ipilimumab in patients with metastatic melanoma using irRC-WHO criteria [ Time Frame: Up to 106 days ]

Estimated Enrollment: 26
Study Start Date: February 2015
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CAVATAK and ipilimumab
CAVATAK intratumoral injection up to a total dose of 3 x 10⁸ TCID50 and ipilimumab intravenously at the recommended dose of 3 mg/kg
Biological: CAVATAK
CAVATAK is a preparation of CVA21
Other Name: Coxsackievirus A21, CVA21
Drug: Ipilimumab
Ipilimumab is a human cytotoxic T-lymphocyte antigen (CTLA-4)-blocking antibody indicated for the treatment of unresectable or metastatic melanoma
Other Name: Yervoy®

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with metastatic or unresectable stage IIIc or IV melanoma for whom treatment with ipilimumab is indicated
  • At least one tumor must qualify to be a target lesion for irRC-WHO
  • ECOG of 0-1
  • Women of childbearing potential must have a negative serum or urine pregnancy test performed within 72 hour prior to the start of treatment
  • No active bleeding
  • Life expectancy > 12 weeks

Exclusion Criteria:

  • Prior ipilimumab treatment for metastatic melanoma (prior ipilimumab as adjuvant permitted if no ≥ grade 3 toxicity)
  • Tumors to be injected lying in mucosal regions or close to airway, major blood vessel or spinal cord that could cause occlusion or compression due to tumor swelling or erosion
  • Active autoimmune disease (excluding autoimmune thyroiditis or vitiligo)
  • Patients with history of colitis
  • Untreated brain metastases.
  • Other active metastatic cancer requiring treatment
  • Active infection requiring antibiotics
  • Pregnant or lactating women
  • Need for chronic steroids
  • Within 28 days of enrollment: WBC < 3.1 x 10⁹ /L; Hgb < 9.0 g/dL; AST or ALT > 1.5 upper limit of normal (ULN); total bilirubin > 1.9 g/dL; prior HIV; prior Hepatitis B; prior Hepatitis C; INR > 1.5 x ULN
  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: NCT02307149

Contacts
Contact: Brendan Curti, MD 5032159948 brendan.curti@providence.org
Contact: Christopher Fountain 5032152691 christopher.fountain@providence.org

Locations
United States, California
UC San Diego Moores Cancer Center Recruiting
La Jolla, California, United States, 92093-0698
Contact: Gregory Daniels, MD, PhD    858-534-3801    gdaniels@ucsd.edu   
Contact: Mario Orozco, CCRC    858 822 0201    mrorozco@ucsd.edu   
John Wayne Cancer Institute Recruiting
Santa Monica, California, United States, 90404
Contact: Mark Faries, MD         
United States, Illinois
Oncology Specialists, SC Recruiting
Park Ridge, Illinois, United States, 60068
Contact: Jon Richards, MD         
Contact: James Puthenveetil    847 410 0659      
United States, Oregon
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
Contact: Brendan D Curti, MD    503-215-5696    brendan.curti@providence.org   
Contact: Christopher Fountain, RN    503 215 2691    Christopher.Fountain@providence.org   
United States, Utah
Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Robert Andtbacka, MD       Robert.Andtbacka@hci.utah.edu   
Contact: Tamara Willis       tamara.willis@hci.utah.edu   
Sponsors and Collaborators
Viralytics
Providence Health & Services
Investigators
Principal Investigator: Brendan Curti, MD Providence Health & Services
  More Information

Responsible Party: Viralytics
ClinicalTrials.gov Identifier: NCT02307149     History of Changes
Other Study ID Numbers: VLA013
PHS IRB: 14-241 ( Other Identifier: Providence Health & Services )
Study First Received: November 26, 2014
Last Updated: April 20, 2017

Keywords provided by Viralytics:
melanoma
ipilimumab
coxsackievirus A21
CAVATAK
CVA21

Additional relevant MeSH terms:
Melanoma
Coxsackievirus Infections
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 23, 2017