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.
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
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]
Single group
Biopsy Procedure
Procedure/SurgeryUndergo tumor biopsy
Biospecimen Collection
Procedure/SurgeryUndergo blood and urine sample collection
Computed Tomography
Procedure/SurgeryUndergo CT scan
Ipilimumab
Biological/VaccineGiven IV
Nivolumab
Biological/VaccineGiven IV
Recombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter
Biological/VaccineGiven IV
Objective response rate (ORR)
A confirmed tumor response is defined to be a complete response (CR) or partial response (PR) noted as the objective status on two consecutive evaluations at least 4 weeks apart. Will be calculated overall and by cohort/subgroup using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Tumor response will be evaluated using all cycles of treatment.
Incidence of adverse events (AEs)
The maximum grade for each type of AE will be recorded for each patient, graded according to NCI CTCAE v5.0.
Disease control rate (DCR)
Defined as the percentage of patients with a CR, PR or stable disease (SD) for at least 2 consecutive tumor assessments (i.e., confirmed CR/PR or SD for ≥ 12 weeks).
Duration of response (DOR)
Defined for all evaluable patients who have achieved an objective response as the date at which the patient's earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented.
Progression free survival (PFS)
Defined as the time from first dose of study drug to the earliest date of documented disease progression or death due to any cause. Assessed using RECIST 1.1.
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