Phase 2 Clinical Evaluation of Combination Immunotherapy for Renal Cell Carcinoma
Mayo Clinic
Summary
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥ 18 years * Disease Characteristics: * 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 embo…
Interventions
- ProcedureBiopsy Procedure
Undergo tumor biopsy
- ProcedureBiospecimen Collection
Undergo blood and urine sample collection
- ProcedureComputed Tomography
Undergo CT scan
- BiologicalIpilimumab
Given IV
- BiologicalNivolumab
Given IV
- BiologicalRecombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter
Given IV
Location
- Mayo Clinic in RochesterRochester, Minnesota