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Melanoma IntraTumoral Cavatak + Ipilimumab (MITCI)

This study is currently recruiting participants.
See Contacts and Locations
Verified August 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: August 18, 2017
Last verified: August 2017
  Purpose
Open label, single arm study of intratumoral CVA21 and ipilimumab in advanced melanoma patients.

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
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:
  • Response [ Time Frame: 106 days ]
    Best response of complete response (CR) or partial response (PR)


Secondary Outcome Measures:
  • DRR [ Time Frame: lasting 26 weeks or longer ]
    Durable Response Rate

  • PFS [ Time Frame: At 6 and 12 months ]
    Progression-Free Survival

  • OS [ Time Frame: Through study completion, an average of 2 years ]
    Overall


Estimated Enrollment: 59
Study Start Date: February 2015
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (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®

Detailed Description:

Primary Objective:

To evaluate the safety and efficacy of CAVATAK (CVA21) administered intratumorally in combination with the approved dose and schedule of ipilimumab. Of particular interest is to estimate the overall response rate (ORR) in the subgroup of subjects with unresectable or metastatic stage III B/C or IV melanoma who have progressed on a single prior anti-PD-1 therapy.

Secondary Objectives:

  1. Assess the clinical efficacy of ipilimumab in combination with intratumoral CVA21 in terms of:

    • Immune-related progression-free survival (irPFS) at 6 and 12 months,
    • Durable response rate (DRR),
    • 1-year survival,
    • Overall survival (OS), and
    • Quality of life.
  2. Assess the response of injected and non-injected melanoma lesions after CVA21 and ipilimumab.
  3. Assess the time to initial response.
  Eligibility

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

Inclusion Criteria:

  1. Patients with unresectable or metastatic stage IIIB/C or IV melanoma. Patients enrolled under this version of the protocol must also have progressed on only one prior anti PD-1 therapy, according to RECIST 1.1 criteria. Patients who progressed within 3 months of treatment start are excluded.
  2. Patients must have at least one cutaneous or subcutaneous tumor, measuring 0.5 to 5.0 cm in the longest diameter, or a palpable lymph node. At least one tumor must qualify as an index lesion that can be accurately and reproducibly measured in two dimensions for which the longest diameter is .10 mm (.15 mm in short axis diameter [SAD] for lymph nodes), and be amenable to intratumoral injection.
  3. Histological confirmation of melanoma will be required by previous biopsy or cytology.
  4. Patients who have received prior ipilimumab treatment for metastatic melanoma are not eligible.
  5. Patients with ≤ 3 visceral metastases (excluding pulmonary lesions), with no lesions >3.0 cm. Patients with substantial tumor burden of non-measurable disease may not be good candidates for an immunotherapy and should be discussed with the Medical Monitor.

7. ECOG performance status of 0-1.

Key Exclusion Criteria:

  1. Patients with tumors to be injected lying close to an airway, major blood vessel or spinal cord that, in the opinion of the Investigator, could cause occlusion or compression in the case of tumor swelling or erosion into a major vessel in the case of necrosis. Patients with lesions in mucosal areas (vulvar, anus, oral cavity, etc.), are eligible, as long as the subject has at least one lesion suitable for injection; consult Medical Monitor for confirmation.
  2. Patients with active, known or suspected autoimmune disease except for autoimmune thyroiditis or vitiligo. Thyroiditis patients must be asymptomatic, on adequate thyroid replacement and have normal thyroid function tests.
  3. Patients with active colitis or immune-mediated colitis that has not resolved to grade 1 or less.
  4. Patients with untreated brain metastases. Patients with treated brain metastases who are off corticosteroids for at least two weeks and who demonstrate control of brain metastases with follow-up imaging 4 or more weeks after initial therapy are eligible.
  5. Patients previously treated with CVA21.
  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: Leslie Guerreiro leslie.guerreiro@viralytics.com

Locations
United States, California
UC San Diego Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Contact: Gregory Daniels, MD, PhD         
John Wayne Cancer Institute Recruiting
Santa Monica, California, United States, 90404
Contact: Steven O'Day, MD         
United States, Florida
Sylvester Comprehensive Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Nicolas Acquavella, MD         
United States, Illinois
Oncology Specialists, SC Recruiting
Park Ridge, Illinois, United States, 60068
Contact: Jon Richards, MD         
United States, New Jersey
Atlantic Melanoma Center Recruiting
Morristown, New Jersey, United States, 07960
Contact: Eric Whitman, MD         
United States, Oregon
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
Contact: Brendan D Curti, MD         
United States, Utah
Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Robert Andtbacka, MD         
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: VLA-013
PHS IRB: 14-241 ( Other Identifier: Providence Health & Services )
Study First Received: November 26, 2014
Last Updated: August 18, 2017

Keywords provided by Viralytics:
melanoma
ipilimumab
coxsackievirus A21
CAVATAK
CVA21
checkpoint inhibitors

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
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 21, 2017