VSV-IFNβ-NIS With Ipilimumab and Nivolumab for the Treatment of Advanced or Metastatic Clear Cell Renal Cell Carcinoma

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07510334
Phase
PHASE2
Status
Recruiting
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Conditions

  • Advanced Clear Cell Renal Cell Carcinoma
  • Metastatic Clear Cell Renal Cell Carcinoma
  • Stage III Renal Cell Cancer AJCC v8
  • Stage IV Renal Cell Cancer AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo tumor biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood and urine sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Ipilimumab — BIOLOGICAL
    Given IV
  • Nivolumab — BIOLOGICAL
    Given IV
  • Recombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter — BIOLOGICAL
    Given IV

Study Details

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.

Key Dates

Start date
Apr 21, 2026
Status verified
Jun 2026
Primary completion
Aug 1, 2033
Completion
Aug 1, 2033

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (VSV-IFNβ-NIS, nivolumab, ipilimumab)
    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.

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: Up to 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Brian A. Costello, MD (PRINCIPAL_INVESTIGATOR)

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Mayo Clinic in Rochester· Rochester, MN

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