VSV-IFNβ-NIS + Ipilimumab + Nivolumab for Kidney Cancer

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Must not be taking: Antiretrovirals, Corticosteroids, others

Disqualifiers: Pregnancy, Prior RCC treatment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 1

Duration: Up to 2 years

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

Brian A. Costello, MD

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

Inclusion Criteria

* Hemoglobin ≥ 9.0 g/dL (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)

* Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nivolumab and ipilimumab IV on day 1 and VSV-IFNβ-NIS IV on day 4 of cycle 1. Cycles 1-4 repeat every 21 days, and cycles 5+ repeat every 28 days for up to 2 years.

Up to 2 years

IV administration on day 1 and day 4 of cycle 1, then every 21 or 28 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including CT scans, blood and urine sample collection, and tumor biopsies.

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Ipilimumab
• Nivolumab
• VSV-IFNβ-NIS

How Is the Trial Designed?

Group I: Treatment (VSV-IFNβ-NIS, nivolumab, ipilimumab) Experimental Treatment 6 Interventions

CYCLES 1-4: Patients receive nivolumab IV, over 30 minutes, and ipilimumab IV, over 30 minutes, on day 1 and VSV-IFNβ-NIS IV, over 30 minutes, on day 4 of cycle 1 only in the absence of disease progression or unacceptable toxicity. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. CYCLES 5+: Patients receive nivolumab IV, over 30 minutes, in the absence of disease progression or unacceptable toxicity. Cycles repeat every 28 days for a total of 2 years of treatment in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and blood and urine sample collection throughout the study, as well as undergo tumor biopsy on study.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+