Phase II Immunotherapeutic Trial: Combination Androgen Ablative Therapy and CTLA-4 Blockade as a Treatment for Advanced Prostate Cancer

摘要

The objectives of this study are to generally test whether the addition of CTLA-4 blockade can enhance clinical treatment responses in advanced prostate cancer patients compared with treatment with AA therapy alone. Patients will be randomized to 3 months of concurrent AA therapy + MDX- 01 0 or 3 months of initial AA therapy alone. Of 25 enrolled patients approximately 10 have received sufficient follow-up to assess whether any treatment effects may be occurring: 10 patients have received AA therapy alone; 11 patients have received AA therapy + MDX-01 0. Those 11 patients who have received AA therapy alone. Specifically the 11 test subjects have experienced faster declines in PSA suggesting that MDX-01 causes hormone therapy to work more effectively than using hormone therapy alone. We have observed that some of the test subjects experienced a more prolonged response (diminished PSA) relative to those that received hormone therapy alone. Based on these preliminary observations our strong hunch is that patients who received AA therapy + MDX-01 0 treatment may be deriving a benefit from the experimental form of therapy beyond that which occurs using standard treatment (which is hormone therapy alone).