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Intratumoral CAVATAK (CVA21) and Ipilimumab in Patients With Advanced Melanoma (VLA-013 MITCI) (MITCI)

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ClinicalTrials.gov Identifier: NCT02307149
Recruitment Status : Active, not recruiting
First Posted : December 4, 2014
Last Update Posted : July 19, 2019
Sponsor:
Collaborator:
Providence Health & Services
Information provided by (Responsible Party):
Viralytics

Brief Summary:
Open label, single arm study of intratumoral CVA21 and ipilimumab in advanced melanoma patients.

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 59 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A PHASE 1b STUDY OF INTRATUMORAL CAVATAK® (COXSACKIEVIRUS A21, CVA21) AND IPILIMUMAB IN PATIENTS WITH ADVANCED MELANOMA (VLA-013 MITCI)
Actual Study Start Date : May 5, 2015
Estimated Primary Completion Date : December 18, 2019
Estimated Study Completion Date : December 18, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
Drug Information available for: Ipilimumab

Arm Intervention/treatment
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®




Primary Outcome Measures :
  1. Response [ Time Frame: 106 days ]
    Best response of complete response (CR) or partial response (PR)


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

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

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



Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Patients with unresectable or metastatic stage III B/C or IV melanoma. Patients enrolled under this version of the protocol must also have progressed on 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.

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): NCT02307149


Locations
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United States, California
City of Hope National Medical Center,
Duarte, California, United States, 91010
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
The Angeles Clinic & Research Institute
Los Angeles, California, United States, 90025
John Wayne Cancer Institute
Santa Monica, California, United States, 90404
United States, Florida
Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
United States, Illinois
Advocate Health, SC
Park Ridge, Illinois, United States, 60068
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, New Jersey
Atlantic Melanoma Center
Morristown, New Jersey, United States, 07960
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Viralytics
Providence Health & Services
Investigators
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Principal Investigator: Brendan Curti, MD Providence Health & Services

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Responsible Party: Viralytics
ClinicalTrials.gov Identifier: NCT02307149     History of Changes
Other Study ID Numbers: V937-009
PHS IRB: 14-241 ( Other Identifier: Providence Health & Services )
VLA-013 ( Other Identifier: Viralytics Study ID )
First Posted: December 4, 2014    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Keywords provided by Viralytics:
melanoma
ipilimumab
coxsackievirus A21
CAVATAK
CVA21
checkpoint inhibitors
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents