Status:
COMPLETED
Intratumoral CAVATAK (CVA21) and Ipilimumab in Patients With Advanced Melanoma (VLA-013 MITCI)
Lead Sponsor:
Viralytics
Collaborating Sponsors:
Providence Health & Services
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 es...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 5 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 5 2019
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02307149
Start Date
May 5 2015
End Date
November 5 2019
Last Update
January 17 2023
Active Locations (11)
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1
City of Hope National Medical Center,
Duarte, California, United States, 91010
2
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
3
The Angeles Clinic & Research Institute
Los Angeles, California, United States, 90025
4
John Wayne Cancer Institute
Santa Monica, California, United States, 90404