18 Participants NeededMy employer runs this trial

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

CT
Overseen ByClinical Trials Referral Office
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new combination treatment for advanced or metastatic clear cell kidney cancer. Researchers are testing whether adding VSV-IFNβ-NIS, a lab-modified virus targeting cancer cells, to standard immune-based therapies (ipilimumab and nivolumab) can more effectively combat this cancer. The goal is to determine if this approach can enhance the immune system's ability to attack the cancer and prevent its spread. Individuals with advanced clear cell kidney cancer that cannot be treated with surgery or radiation might be suitable candidates for this trial. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants, offering a chance to contribute to significant advancements in cancer therapy.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you are receiving certain treatments like chemotherapy, immunotherapy, or radiotherapy, or if you have uncontrolled illnesses. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that VSV-IFNβ-NIS is safe and well-tolerated by patients. Research indicates that this treatment targets cancer cells without harming healthy ones. Clinical trials have not reported major safety concerns, suggesting it is generally safe for humans.

Studies have demonstrated that ipilimumab and nivolumab have a manageable safety profile. Patients with advanced kidney cancer have tolerated these treatments well. Some side effects can occur, but they are usually controllable. Overall, the combination of these treatments has proven effective and safe for many patients.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for kidney cancer because they combine innovative approaches to boost the immune system's fight against cancer. Unlike standard treatments, which often focus on surgery or radiation, this combination uses VSV-IFNβ-NIS, a modified virus designed to selectively attack cancer cells while sparing healthy ones, alongside the immune checkpoint inhibitors ipilimumab and nivolumab. These inhibitors work by unleashing the immune system to recognize and destroy cancer cells more effectively. This combined therapy could offer more precise targeting of cancer cells and potentially lead to better outcomes for patients.

What evidence suggests that this trial's treatments could be effective for kidney cancer?

Research has shown that using nivolumab and ipilimumab together effectively treats advanced kidney cancer. One study found that participants taking this combination had a 37% lower risk of death compared to those taking sunitinib. This combination is associated with longer survival and more lasting treatment effects. In this trial, participants will receive a combination of nivolumab, ipilimumab, and VSV-IFNβ-NIS. VSV-IFNβ-NIS is a promising new therapy that uses a virus to target and kill cancer cells while sparing normal cells. Early studies suggest that adding this virus could boost the immune system and help control cancer growth.12567

Who Is on the Research Team?

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Brian A. Costello, MD

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

This trial is for adults (18+) with advanced or metastatic clear cell kidney cancer who have measurable disease and good organ function. Participants must be well enough to carry out daily activities, and certain previously treated liver lesions or irradiated tumors can't be used as target areas.

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.
See 7 more

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

Trial Overview

The study is testing a new virus-based treatment called VSV-IFNβ-NIS added to standard immunotherapy drugs ipilimumab and nivolumab in people with advanced or spreading clear cell kidney cancer. The goal is to see if this combination works better than the usual care.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Treatment (VSV-IFNβ-NIS, nivolumab, ipilimumab)Experimental Treatment6 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Citations

Enhanced efficacy of ipilimumab plus nivolumab in ...

The BIONIKK trial revealed that ipilimumab plus nivolumab (Ipi/Nivo) achieved a 70% objective response rate in angiogenic cluster1/2 versus 41% in cluster4/5.

Real-World Outcomes of First-Line Ipilimumab Plus ...

Patients achieving CR or PR had superior survival (median OS not reached and 40.8 months) versus PD (7.3 months). Improved OS was associated with completion of ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39705641/

Real-World Outcomes in Patients With Metastatic Renal ...

This study provides data to support the understanding of the real-world utilization and long-term effectiveness of 1L NIVO + IPI in patients ...

Nivolumab plus ipilimumab versus sunitinib for first-line ...

Superior survival, durable response benefits, and a manageable safety profile were maintained with NIVO+IPI versus SUN at 8 years, the longest ...

Nivolumab plus Ipilimumab versus Sunitinib in Advanced ...

Nivolumab plus ipilimumab produced objective responses in patients with advanced renal-cell carcinoma in a pilot study. This phase 3 trial ...

ASCO 2021: Safety and Efficacy Outcomes with Nivolumab ...

Combination therapy with nivolumab plus ipilimumab has demonstrated long-term efficacy and tolerability in patients with previously untreated advanced RCC.

Efficacy and safety of nivolumab plus ipilimumab in ...

Similarly, the median PFS was 4.3 months (95% CI: 1.4 – NE) for nephrectomy patients and 5.1 months (95% CI: 2.3 to 9.6) for those without ...