Study of VSV-IFNβ-NIS with Ipilimumab and Nivolumab for Advanced Kidney Cancer
This study is testing a new approach for advanced or metastatic clear cell renal cell carcinoma (a type of kidney cancer that has spread). It combines a modified virus called VSV-IFNβ-NIS with two immunotherapy drugs, ipilimumab and nivolumab. The modified virus may be able to kill cancer cells without harming healthy ones. Ipilimumab and nivolumab are designed to help your body's immune system fight the cancer. The study aims to see how many participants experience a positive response to this treatment. You may be eligible if you are at least 18 years old and have advanced or metastatic clear cell renal cell carcinoma. The study plans to enroll 18 participants, but its current status is unclear.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 18 participants.
- What's involved
- Participants will undergo a tumor biopsy, blood and urine sample collection, and CT scans. They will also receive ipilimumab and nivolumab intravenously (IV).
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure how well the treatment works for up to 5 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07510334
VSV-IFNβ-NIS With Ipilimumab and Nivolumab for the Treatment of Advanced or Metastatic Clear Cell Renal Cell Carcinoma
Recruiting
PHASE2Ages 18+InterventionalTreatmentMayo ClinicInvestigator-initiated
~18 participants
Updated 2026-06-05 on ClinicalTrials.gov
What's tested:Biopsy ProcedureBiospecimen CollectionComputed TomographyIpilimumabNivolumabRecombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective response rate (ORR)
Measured over Up to 5 years
Conditions
NCT07510334
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Mayo Clinic in Rochester
Rochester, Minnesotastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Brian A. Costello, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Eligibility criteria
Inclusion
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 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
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
Hemoglobin ≥ 9.0 g/dL (obtained ≤ 15 days prior to registration)
Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (obtained ≤ 15 days prior to registration)
Platelet count ≥ 100,000/mm\^3 (obtained ≤ 15 days prior to registration)
Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 15 days prior to registration)
Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) (obtained ≤ 15 days prior to registration)
Prothrombin time (PT)/international normalization ratio (INR)/activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy (≤ 5 x ULN for patients with liver involvement) (obtained ≤ 15 days prior to registration)
Serum creatinine ≤ 1.5 x upper limit of normal (ULN) OR creatinine clearance ≥ 50 ml/min using the chronic kidney disease epidemiology (CKD-EPI) creatinine equation (per National Kidney Foundation) (obtained ≤ 15 days prior to registration)
NOTE: See calculator at National Kidney Foundation website here: https://www.kidney.org/professionals/kdoqi/gfr\_calculator
Negative pregnancy test done ≤ 8 days prior to registration, for persons of childbearing potential only
Provide written informed consent
Willingness to provide mandatory blood specimens for correlative research
Willingness to provide mandatory tissue specimens for correlative research
Willing to return to Mayo Clinic for follow-up (during the active monitoring phase of the study)
Patients known to be HIV positive and currently receiving antiretroviral therapy
Known history of active tuberculosis (TB) (bacillus tuberculosis)
Uncontrolled hypertension and/or diabetes
Clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease requiring hospitalization ≤ 3 months prior to treatment)
Receiving concurrent anti-cancer therapy (chemotherapy, immunotherapy, radiotherapy, or any other investigational agent or therapy considered investigational (used for a non-Food and Drug Administration (FDA) approved indication and in the context of a research investigation)
Known concurrent malignancy that is progressing or requires active treatment
EXCEPTIONS: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in-situ cervical cancer that has been treated with curative intent, prostate cancer confined to the prostate gland with Gleason score ≤ 6, as well as any cancer treated with curative intent or any prior cancer with a disease-free interval of ≥ 3 years
History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
Exclusion
Any of the following because this study involves an investigational agent, the genotoxic, mutagenic and teratogenic effects of which on the developing fetus and newborn are unknown:
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 \[American Joint Committee on Cancer (AJCC) Stage IV\]
History of portal vein thrombosis involving more than intrahepatic portal vein branches: thrombosis of the right or left portal vein branch or the bifurcation, partial or complete obstruction of the portal vein trunk
NOTE: Level 0 or 1 tumor thrombus remain eligible; Level 2, 3, of 4 tumor thrombus related to the primary kidney tumor are ineligible
Has received a live vaccine ≤ 30 days prior to registration
NOTE: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines and are NOT allowed
Any of the following prior therapies:
Surgery ≤ 3 weeks prior to registration
Chemotherapy ≤ 2 weeks prior to registration
Radiation therapy ≤ 2 weeks prior to registration
Therapy in the first-line setting for advanced or metastatic RCC
Adjuvant immunotherapy during which or in the ≤ 6 months immediately following, relapse or disease progression has occurred
New York Heart Association classification III or IV, known symptomatic coronary artery disease, or symptoms of coronary artery disease on systems review, or known cardiac arrhythmias \[atrial fibrillation or supraventricular tachycardia (SVT)\]
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Uncontrolled intercurrent illness including, but not limited to:
ongoing or active infection
symptomatic congestive heart failure
unstable angina pectoris
cardiac arrhythmia
dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy
or psychiatric illness/social situations that would limit compliance with study requirements
Current immunodeficiency or immunosuppression and receiving systemic corticosteroids at \> 10mg/day prednisone or equivalent ≤ 1 week prior to registration.
NOTE: Inhaled steroids for pulmonary disease are permitted
Known history of the following:
Suspected active organ-threatening autoimmune disease including, but not limited to, inflammatory bowel disease, autoimmune hepatitis, lupus, or pneumonitis which can flare while receiving immune checkpoint inhibitor (ICI) treatment.
NOTE: Patients with well-controlled or clinically inactive autoimmune diseases are eligible
Non-infectious pneumonitis that required steroids, current pneumonitis, carcinomatous meningitis, or interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
Known or ongoing illness or infection including:
Any active Grade 3 or higher \[per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version (v) 5.0\] viral, bacterial, or fungal infection ≤ 2 weeks of registration.
Acute hepatitis B (HBV) or acute hepatitis C virus (HCV)
What this trial measures
- Objective response rate (ORR)Up to 5 years
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.