Full TitleA Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Escalating Doses of a Vaccine-Based Immunotherapy Regimen (VBIR) for Prostate Cancer (PF-06753512)
The purpose of this study is to evaluate the safety and preliminary effectiveness of an investigational treatment for prostate cancer designed to work by triggering an immune response against the cancer. The treatment includes a vaccine that contains an inactive virus that presents to the body three proteins (antigens) specific for prostate cancer. After receiving the vaccine, the immune system can then look for and kill prostate cancer cells containing these three antigens.
Another part of the treatment is a vaccine “booster” made of circular DNA called plasmid DNA. This part of the treatment is designed to bolster the immune response against prostate cancer cells, a response which may otherwise dampen over time.
Finally, some patients in this study will receive a drug called tremelimumab on the same day they receive the plasmid DNA. Tremelimumab is an investigational drug that works by preventing the immune response from being “turned off.” One group of patients will receive all of these treatments as well as a drug called sunitinib to help keep the immune response turned on.
The vaccine and plasmid DNA are given as intramuscular injections, and tremelimumab is given as a subcutaneous (under the skin) injection. Sunitinib is taken orally (by mouth).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have advanced prostate cancer that has spread or persists despite prior treatment (including hormonal therapies), or prostate cancer that was treated with local therapies (such as surgery or radiation therapy) and exhibits rising PSA.
- At least 4 weeks must pass between completion of prior treatment and entry into the study. Patients may not be receiving other immunotherapy for prostate cancer concurrently.
- There will be different groups of patients enrolled at different times in the study. The first group of men will have experienced progression of their cancer on standard hormonal therapy or androgen deprivation therapy. Later groups of men will have experienced progression of their cancer on androgen deprivation therapy as well as newer anti-androgen directed therapies, such as abiraterone or enzalutamide
- All patients with metastatic prostate cancer are required to continue taking standard androgen deprivation therapy.
- Patients who have received chemotherapy for metastatic prostate cancer may not participate.
- Patients must be able to walk and do routine activities for more than half of their normal waking hours.
- This study is for men age 18 and older.