About this trial
This phase II trial tests adding VSV-IFNβ-NIS to standard of care ipilimumab and nivolumab for the treatment of clear cell renal cell carcinoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). A virus modified in the laboratory, such as VSV-IFNβ-NIS, may be able to kill tumor cells without damaging normal cells. Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving VSV-IFNβ-NIS with ipilimumab and nivolumab may be effective for the treatment of advanced or metastatic clear cell renal cell carcinoma.
Eligibility criteria
Qualifiers
Age ≥ 18 years
Histological confirmation of advanced (not amenable to curative surgery or radiation therapy) or metastatic [American Joint Committee on Cancer (AJCC) version 8 Stage IV] renal cell carcinoma (RCC) with a clear cell component, including all International Metastatic RCC Database Consortium (IMDC) risk categories (favorable, intermediate, and poor risk) allowed
Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
NOTE: Liver lesions that have been previously embolized (bland embolization, chemo- or radio-embolization) or have undergone percutaneous thermoablation are not eligible as target lesions. Tumor lesions in a previously irradiated area are not considered measurable disease; disease that is measurable by physical examination only is not eligible
Disqualifiers
Pregnant persons
Nursing persons
Persons of childbearing potential and persons able to father a child who are unwilling to employ adequate contraception
Prior treatment for advanced or metastatic RCC [American Joint Committee on Cancer (AJCC) Stage IV]
Trial design
Treatments tested in this trial
- Biopsy Procedure
- Biospecimen Collection
- Computed Tomography
- Ipilimumab
- Nivolumab
- Recombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter