Trials / Not Yet Recruiting
Not Yet RecruitingNCT07510334
VSV-IFNβ-NIS With Ipilimumab and Nivolumab for the Treatment of Advanced or Metastatic Clear Cell Renal Cell Carcinoma
Phase 2 Clinical Evaluation of Combination Immunotherapy for Renal Cell Carcinoma
- Status
- Not Yet Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Biopsy Procedure | Undergo tumor biopsy |
| PROCEDURE | Biospecimen Collection | Undergo blood and urine sample collection |
| PROCEDURE | Computed Tomography | Undergo CT scan |
| BIOLOGICAL | Ipilimumab | Given IV |
| BIOLOGICAL | Nivolumab | Given IV |
| BIOLOGICAL | Recombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter | Given IV |
Timeline
- Start date
- 2026-05-01
- Primary completion
- 2033-08-01
- Completion
- 2033-08-01
- First posted
- 2026-04-03
- Last updated
- 2026-04-03
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07510334. Inclusion in this directory is not an endorsement.