19 Participants Needed

NeoVax + Ipilimumab for Kidney Cancer

PO
TC
Overseen ByToni Choueiri, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot be on certain immune-modulatory agents or other investigational cancer therapies, and you should not be using corticosteroids above a certain dose. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment NeoVax + Ipilimumab for kidney cancer?

Research suggests that personalized mRNA vaccines, like NeoVax, show clinical benefits in solid tumors by targeting specific tumor antigens, and immune checkpoint inhibitors like Ipilimumab have been effective in enhancing immune responses in cancer therapy. Additionally, studies indicate that certain immune subtypes of kidney cancer may respond better to these personalized vaccine approaches.12345

Is the combination of NeoVax and Ipilimumab safe for humans?

Ipilimumab, when used with other treatments like nivolumab for kidney cancer, can cause immune-related side effects, which are reactions where the immune system attacks normal organs and tissues. These side effects can vary in severity, but they are a known risk when using this type of treatment.678910

What makes the NeoVax + Ipilimumab treatment unique for kidney cancer?

The NeoVax + Ipilimumab treatment is unique because it combines a personalized cancer vaccine with an immune checkpoint inhibitor, potentially offering a tailored approach to stimulate the immune system specifically against kidney cancer, unlike standard treatments that do not include personalized vaccines.1112131415

What is the purpose of this trial?

This research study is evaluating a new type of Kidney Cancer vaccine called "Personalized NeoAntigen Cancer Vaccine"as a possible treatment for Kidney Cancer.The following intervention will be involved in this study:* Personalized Neoantigen Vaccine* Poly-ICLC (Hiltonol)* Ipilimumab

Research Team

Patrick Ott, MD, PhD - Dana-Farber ...

Patrick Ott, MD, PhD

Principal Investigator

Dana-Farber Cancer Institute

Toni Choueiri, MD - Dana-Farber Cancer ...

Toni Choueiri, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for adults over 18 with stage III or IV clear cell renal cell carcinoma (ccRCC) that can be surgically removed. Participants must understand and sign a consent form, agree to provide tissue samples, have an ECOG performance status ≤1, and meet certain blood test criteria.

Inclusion Criteria

absolute neutrophil count ≥1,500/mcL
I am suspected to have advanced kidney cancer that can be entirely removed by surgery.
Ability to understand and the willingness to sign a written informed consent document.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Patients will undergo surgery with the intent to resect the primary kidney tumor

1 week

Priming Treatment

Priming doses of NeoVax will be administered on days 1, 4, 8, 15, and 22

3 weeks
5 visits (in-person)

Boost Phase

Vaccine will be administered on days 78 (week 12) and 134 (week 20)

8 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Ipilimumab
  • Personalized NeoAntigen Cancer Vaccine
Trial Overview The study tests a new vaccine called 'Personalized NeoAntigen Cancer Vaccine' alongside Poly-ICLC (Hiltonol) and Ipilimumab as potential treatments for kidney cancer. The aim is to see if this combination helps in treating ccRCC after surgery.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Neovax in Combination with IpilimumabExperimental Treatment2 Interventions
Patients will undergo surgery with the intent to resect the primary kidney tumor Neovax is a combination of Poly-ICLC and Neoantigen Peptides Priming doses of NeoVax will be administered on days 1, 4, 8, 15, and 22 * In the boost phase, vaccine will be administered on days 78 (week 12) and 134 (week 20 Ipilimumab will be injected within 1 cm of each NeoVax administration
Group II: NeoVax aloneExperimental Treatment1 Intervention
Patients will undergo surgery with the intent to resect the primary kidney tumor Neovax is a combination of Poly-ICLC and Neoantigen Peptides Priming doses of NeoVax will be administered on days 1, 4, 8, 15, and 22 * In the boost phase, vaccine will be administered on days 78 (week 12) and 134 (week 20)

Ipilimumab is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Yervoy for:
  • Advanced melanoma
  • Stage III unresectable melanoma
  • Stage IV metastatic melanoma
🇪🇺
Approved in European Union as Yervoy for:
  • Advanced melanoma
  • Stage III unresectable melanoma
  • Stage IV metastatic melanoma

Find a Clinic Near You

Who Is Running the Clinical Trial?

Patrick Ott, MD

Lead Sponsor

Trials
2
Recruited
30+

Patrick Ott, MD, PhD

Lead Sponsor

Trials
2
Recruited
30+

Bristol-Myers Squibb

Industry Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Oncovir, Inc.

Industry Sponsor

Trials
25
Recruited
680+

Findings from Research

All patients with renal cell carcinoma (RCC) expressed at least one tumor-associated antigen (TAA), with 80% showing two or more, indicating a strong potential for T-cell activation in immunotherapy.
Based on HLA expression analysis, at least 30% of RCC patients are eligible for monovalent immunotherapy and 41% for polyvalent immunotherapy, supporting the rationale for future vaccination trials.
Simultaneous expression of T-cell activating antigens in renal cell carcinoma: implications for specific immunotherapy.Ringhoffer, M., Müller, CR., Schenk, A., et al.[2019]
In a study of 52 patients with metastatic renal cell carcinoma treated with nivolumab plus ipilimumab, the 1-year progression-free survival rate was 55% and the overall survival rate was 75%, indicating promising efficacy of this treatment combination.
The treatment was associated with a 39% objective response rate, and while 69% of patients experienced immune-related adverse events, the incidence of severe events was lower compared to previous studies, suggesting a favorable safety profile.
Efficacy and safety of first-line nivolumab plus ipilimumab in patients with metastatic renal cell carcinoma: A multicenter retrospective study.Tanaka, T., Hatakeyama, S., Numakura, K., et al.[2021]
In a study of 69 patients with metastatic renal cell carcinoma treated with nivolumab plus ipilimumab, those who experienced immune-related adverse events (irAEs) had significantly better overall survival (OS) and progression-free survival compared to those without irAEs, suggesting that irAEs may be a positive indicator of treatment response.
The study identified three key factors influencing OS: the presence of irAEs, C-reactive protein levels, and performance status, indicating that monitoring these factors could help predict patient outcomes in mRCC treatment.
Prognostic Impact of Immune-Related Adverse Events as First-Line Therapy for Metastatic Renal Cell Carcinoma Treated With Nivolumab Plus Ipilimumab: A Multicenter Retrospective Study.Nukaya, T., Takahara, K., Yoshizawa, A., et al.[2023]

References

Tumor antigens and immune subtypes guided mRNA vaccine development for kidney renal clear cell carcinoma. [2022]
Collection of real-world data on nivolumab's effectiveness in renal cell carcinoma: rationale for an observational study. [2018]
Immunogenicity in renal cell carcinoma: shifting focus to alternative sources of tumour-specific antigens. [2023]
Simultaneous expression of T-cell activating antigens in renal cell carcinoma: implications for specific immunotherapy. [2019]
A new age for vaccine therapy in renal cell carcinoma. [2022]
Efficacy and safety of first-line nivolumab plus ipilimumab in patients with metastatic renal cell carcinoma: A multicenter retrospective study. [2021]
Comparison of the Impact of Immune-Related Adverse Events Due to Immune Checkpoint Inhibitor Dual Combination Therapy and Immune Checkpoint Inhibitor Plus Tyrosine Kinase Inhibitor Combination Therapy in Patients with Advanced Renal Cell Carcinoma. [2023]
Prognostic Impact of Immune-Related Adverse Events as First-Line Therapy for Metastatic Renal Cell Carcinoma Treated With Nivolumab Plus Ipilimumab: A Multicenter Retrospective Study. [2023]
Prognostic impact of immune-related adverse events in metastatic renal cell carcinoma treated with nivolumab plus ipilimumab. [2022]
Immune-related adverse events are clinical biomarkers to predict favorable outcomes in advanced renal cell carcinoma treated with nivolumab plus ipilimumab. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Utilization and Safety of Ipilimumab Plus Nivolumab in a Real-World Cohort of Metastatic Renal Cell Carcinoma Patients. [2022]
European Medicines Agency extension of indication to include the combination immunotherapy cancer drug treatment with nivolumab (Opdivo) and ipilimumab (Yervoy) for adults with intermediate/poor-risk advanced renal cell carcinoma. [2021]
Safe and effective use of nivolumab plus ipilimumab in a patient with metastatic clear-cell renal cell carcinoma with sarcomatoid dedifferentiation and end stage renal disease on hemodialysis. [2022]
14.United Statespubmed.ncbi.nlm.nih.gov
Standard Versus Modified Ipilimumab, in Combination With Nivolumab, in Advanced Renal Cell Carcinoma: A Randomized Phase II Trial (PRISM). [2023]
Nivolumab for the Treatment of Patients with Metastatic Non-Clear Cell Renal Cell Carcinoma (nccRCC): A Single-Institutional Experience and Literature Meta-Analysis. [2021]
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