Intratumoral CAVATAK (CVA21) and Ipilimumab in Patients With Advanced Melanoma (VLA-013 MITCI) (MITCI)
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|ClinicalTrials.gov Identifier: NCT02307149|
Recruitment Status : Completed
First Posted : December 4, 2014
Last Update Posted : January 17, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Biological: CAVATAK Drug: Ipilimumab||Phase 1|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A PHASE 1b STUDY OF INTRATUMORAL CAVATAK® (COXSACKIEVIRUS A21, CVA21) AND IPILIMUMAB IN PATIENTS WITH ADVANCED MELANOMA (VLA-013 MITCI)|
|Actual Study Start Date :||May 5, 2015|
|Actual Primary Completion Date :||November 5, 2019|
|Actual Study Completion Date :||November 5, 2019|
Experimental: 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
CAVATAK is a preparation of CVA21
Other Name: Coxsackievirus A21, CVA21
Ipilimumab is a human cytotoxic T-lymphocyte antigen (CTLA-4)-blocking antibody indicated for the treatment of unresectable or metastatic melanoma
Other Name: Yervoy®
- Response [ Time Frame: 106 days ]Best response of complete response (CR) or partial response (PR)
- DRR [ Time Frame: lasting 26 weeks or longer ]Durable Response Rate
- PFS [ Time Frame: At 6 and 12 months ]Progression-Free Survival
- OS [ Time Frame: Through study completion, an average of 2 years ]Overall
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02307149
|United States, California|
|City of Hope National Medical Center,|
|Duarte, California, United States, 91010|
|UC San Diego Moores Cancer Center|
|La Jolla, California, United States, 92093|
|The Angeles Clinic & Research Institute|
|Los Angeles, California, United States, 90025|
|John Wayne Cancer Institute|
|Santa Monica, California, United States, 90404|
|United States, Florida|
|Sylvester Comprehensive Cancer Center|
|Miami, Florida, United States, 33136|
|United States, Illinois|
|Advocate Health, SC|
|Park Ridge, Illinois, United States, 60068|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|United States, New Jersey|
|Atlantic Melanoma Center|
|Morristown, New Jersey, United States, 07960|
|United States, Oregon|
|Providence Portland Medical Center|
|Portland, Oregon, United States, 97213|
|United States, Utah|
|Huntsman Cancer Institute|
|Salt Lake City, Utah, United States, 84112|
|Principal Investigator:||Brendan Curti, MD||Providence Health & Services|
|Other Study ID Numbers:||
PHS IRB: 14-241 ( Other Identifier: Providence Health & Services )
VLA-013 ( Other Identifier: Viralytics Study ID )
|First Posted:||December 4, 2014 Key Record Dates|
|Last Update Posted:||January 17, 2023|
|Last Verified:||January 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action