NeoVax + Ipilimumab for Kidney Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Toni Choueiri, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Patrick Ott, MD

No Placebo Group

Breakthrough Therapy

Trial Summary

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

absolute neutrophil count ≥1,500/mcL

I am 18 years old or older.

I am suspected to have advanced kidney cancer that can be entirely removed by surgery.

Treatment Details

Interventions

• Ipilimumab (CTLA-4 Inhibitor)
• Personalized NeoAntigen Cancer Vaccine (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

Group I: Neovax in Combination with Ipilimumab Experimental Treatment 2 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 alone Experimental Treatment 1 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)

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

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

Trials

25

Recruited

680+