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

Melanoma Clinical Trial

— MITCI  

Official title:

A PHASE 1b STUDY OF INTRATUMORAL CAVATAK® (COXSACKIEVIRUS A21, CVA21) AND IPILIMUMAB IN PATIENTS WITH ADVANCED MELANOMA (VLA-013 MITCI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02307149
• Other study ID #: V937-009
• Secondary ID: PHS IRB: 14-241V
• Status: Completed
• Phase: Phase 1
• Start date: May 5, 2015
• Est. completion date: November 5, 2019

Study information

• Verified date: January 2023
• Source: Viralytics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 5, 2019
• Est. primary completion date: November 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma

Intervention

Biological:
• CAVATAK
CAVATAK is a preparation of CVA21

Drug:
• Ipilimumab
Ipilimumab is a human cytotoxic T-lymphocyte antigen (CTLA-4)-blocking antibody indicated for the treatment of unresectable or metastatic melanoma

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	City of Hope National Medical Center,	Duarte	California
United States	UC San Diego Moores Cancer Center	La Jolla	California
United States	The Angeles Clinic & Research Institute	Los Angeles	California
United States	Sylvester Comprehensive Cancer Center	Miami	Florida
United States	Atlantic Melanoma Center	Morristown	New Jersey
United States	Advocate Health, SC	Park Ridge	Illinois
United States	Providence Portland Medical Center	Portland	Oregon
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	John Wayne Cancer Institute	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
Viralytics	Providence Health & Services

Country where clinical trial is conducted

United States, 

References & Publications (1)

Curti BD, Richards J, Hyngstrom JR, Daniels GA, Faries M, Feun L, Margolin KA, Hallmeyer S, Grose M, Zhang Y, Li A, Andtbacka RHI. Intratumoral oncolytic virus V937 plus ipilimumab in patients with advanced melanoma: the phase 1b MITCI study. J Immunother — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response	Best response of complete response (CR) or partial response (PR)	106 days
Secondary	DRR	Durable Response Rate	lasting 26 weeks or longer
Secondary	PFS	Progression-Free Survival	At 6 and 12 months
Secondary	OS	Overall	Through study completion, an average of 2 years