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

Completed · Phase 1

Conditions studied: Melanoma

In brief

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

Key facts

Study ID

NCT02307149

Run by

Viralytics

People needed

50

Starts

2015-05-05

Expected to finish

2019-11-05

Last updated by the study team

2023-01-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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