NeoVax + Ipilimumab for Kidney Cancer
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
Principal Investigator
Dana-Farber Cancer Institute
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
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Surgery
Patients will undergo surgery with the intent to resect the primary kidney tumor
Priming Treatment
Priming doses of NeoVax will be administered on days 1, 4, 8, 15, and 22
Boost Phase
Vaccine will be administered on days 78 (week 12) and 134 (week 20)
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Ipilimumab
- Personalized NeoAntigen Cancer Vaccine
Ipilimumab is already approved in United States, European Union for the following indications:
- Advanced melanoma
- Stage III unresectable melanoma
- Stage IV metastatic melanoma
- 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
Patrick Ott, MD, PhD
Lead Sponsor
Bristol-Myers Squibb
Industry Sponsor
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
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