Cancer is driven by genetic mutations that cause uncontrolled cell growth. Immunotherapies like neoantigen vaccines take advantage of these mutations to trigger targeted immune responses with fewer side effects. While this approach holds great promise, developing a personalized vaccine for every patient is costly and time- and labor- intensive. Dr. Nina Bhardwaj and colleagues are exploring a more practical solution: an “off-the-shelf” vaccine that targets mutations commonly shared across many patients.
Non-muscle invasive bladder cancer (NMIBC) accounts for 75-80% of all newly diagnosed bladder cancers, and patients with intermediate- or high-risk NMIBC face high rates of recurrence and disease progression. Most intermediate-risk patients have mutations in the FGFR3 gene, making it an ideal target for a shared vaccine approach. Prior studies have shown that FGFR3 mutations can stimulate anti-tumor immune responses and that vaccines targeting these mutations can produce both clinical and immunologic benefits.
This new clinical trial will evaluate two different FGFR3-targeted treatment strategies for patients with intermediate-risk NMIBC: 1) a vaccine targeting FGFR3 mutations and 2) a novel slow-release bladder-inserted device (TAR-210) that delivers an FGFR3 inhibitor directly to the tumor. Patients will receive either TAR-210 alone or TAR-210 plus the vaccine to determine whether the combination improves outcomes. This innovative study aims to make targeted immunotherapy more accessible, durable, and scalable for patients with bladder cancer.
Projects and Grants
Randomized phase 1b trial of shared FGFR3 neoantigen peptide vaccine in combination with TAR-210 or TAR-210 monotherapy for FGFR3-mutated intermediate-risk non‐muscle invasive bladder cancer
Co-Investigators
- Jonathan Anker, MD, PhD
- Mesude Bicak, PhD
- Marcio Diniz, PhD
- Matthew Galsky, MD
- Mansi Saxena, PhD
- John Sfakianos, MD
