Melanoma Clinical Trial

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

Summary

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

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Full 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:

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.
Assess the response of injected and non-injected melanoma lesions after CVA21 and ipilimumab.
Assess the time to initial response.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.
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.
Histological confirmation of melanoma will be required by previous biopsy or cytology.
Patients who have received prior ipilimumab treatment for metastatic melanoma are not eligible.
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:

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.
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.
Patients with active colitis or immune-mediated colitis that has not resolved to grade 1 or less.
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.
Patients previously treated with CVA21.

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

50

Study ID:

NCT02307149

Recruitment Status:

Completed

Sponsor:

Viralytics

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There are 11 Locations for this study

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

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

50

Study ID:

NCT02307149

Recruitment Status:

Completed

Sponsor:


Viralytics

How clear is this clinincal trial information?

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