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

NCT ID: NCT02307149

Last Updated: 2023-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-05
• Study Completion Date: 2019-11-05

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.

Conditions

Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

CAVATAK

Intervention Type: BIOLOGICAL

CAVATAK is a preparation of CVA21

Ipilimumab

Intervention Type: DRUG

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

Interventions

CAVATAK

CAVATAK is a preparation of CVA21

Intervention Type: BIOLOGICAL

Ipilimumab

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

Intervention Type: DRUG

Other Intervention Names

Coxsackievirus A21, CVA21; Yervoy®

Eligibility 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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Providence Health & Services

OTHER

Sponsor Role: collaborator

Viralytics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brendan Curti, MD

Role: PRINCIPAL_INVESTIGATOR

Providence Health & Services

Locations

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

John Wayne Cancer Institute

Santa Monica, California, United States

Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Advocate Health, SC

Park Ridge, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Atlantic Melanoma Center

Morristown, New Jersey, United States

Providence Portland Medical Center

Portland, Oregon, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Countries

United States

References

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 Cancer. 2022 Dec;10(12):e005224. doi: 10.1136/jitc-2022-005224.

Reference Type: RESULT

PMID: 36564126 (View on PubMed)

Other Identifiers

PHS IRB: 14-241

Identifier Type: OTHER

Identifier Source: secondary_id

VLA-013

Identifier Type: OTHER

Identifier Source: secondary_id

V937-009

Identifier Type: -

Identifier Source: org_study_id