Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02307149
Recruitment Status : Completed
First Posted : December 4, 2014
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
Providence Health & Services
Information provided by (Responsible Party):
Viralytics

Tracking Information
First Submitted Date  ICMJE November 26, 2014
First Posted Date  ICMJE December 4, 2014
Last Update Posted Date January 18, 2020
Actual Study Start Date  ICMJE May 5, 2015
Actual Primary Completion Date November 5, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2017)
Response [ Time Frame: 106 days ]
Best response of complete response (CR) or partial response (PR)
Original Primary Outcome Measures  ICMJE
 (submitted: December 2, 2014)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2014)
Estimate the objective response rate to CAVATAK and ipilimumab in patients with metastatic melanoma using irRC-WHO criteria [ Time Frame: Up to 106 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intratumoral CAVATAK (CVA21) and Ipilimumab in Patients With Advanced Melanoma (VLA-013 MITCI)
Official Title  ICMJE A PHASE 1b STUDY OF INTRATUMORAL CAVATAK® (COXSACKIEVIRUS A21, CVA21) AND IPILIMUMAB IN PATIENTS WITH ADVANCED MELANOMA (VLA-013 MITCI)
Brief Summary Open label, single arm study of intratumoral CVA21 and ipilimumab in advanced melanoma patients.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Melanoma
Intervention  ICMJE
  • 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®
Study Arms  ICMJE 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
Interventions:
  • Biological: CAVATAK
  • Drug: Ipilimumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 14, 2020)
50
Original Estimated Enrollment  ICMJE
 (submitted: December 2, 2014)
26
Actual Study Completion Date  ICMJE November 5, 2019
Actual Primary Completion Date November 5, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02307149
Other Study ID Numbers  ICMJE V937-009
PHS IRB: 14-241 ( Other Identifier: Providence Health & Services )
VLA-013 ( Other Identifier: Viralytics Study ID )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Responsible Party Viralytics
Study Sponsor  ICMJE Viralytics
Collaborators  ICMJE Providence Health & Services
Investigators  ICMJE
Principal Investigator: Brendan Curti, MD Providence Health & Services
PRS Account Viralytics
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP