Nivolumab as a Non-Castrating Therapy for MMR-deficient and CDK12-Altered Prostate Cancer with PSA Recurrence After Local Therapy
Johns Hopkins Kimmel Cancer Center in Baltimore
The primary objective of the study is to find out if the study drug (Nivolumab) leads to lowering of PSA levels in men with biochemically recurrent (i.e. rising PSA in the absence of metastatic disease) prostate cancer and whose cancer has a mutation in a gene involved in repairing DNA damage (i.e. mismatch repair).This study is based on our prior studies showing that immunotherapy (such as nivolumab) is effective at treating the cancer in individuals with these specific DNA repair gene mutations (mismatch repair deficiency). We are studying if nivolumab is effective for patients who have had a biochemical recurrence of their prostate cancer, which harbors a mismatch repair mutation before they develop metastatic disease.Nivolumab (BMS-936558) is a human monoclonal antibody made in a laboratory. Antibodies exist normally in your body. An antibody is a type of protein normally made by immune cells that helps protect the body against foreign matter, such as bacteria and viruses. These antibodies attach, or bind to,foreign matter in a very specific way, and this binding helps the body clear the infection. Nivolumab works by attaching to and blocking a protein called PD-1. PD-1 is present on different types of cells in the immune system and can shut down the immune cells so that they do not effectively fight disease. Antibodies that block the PD-1 protein on these immune cells can potentially stop PD-1 from shutting down the immune cells, thus allowing the cells to recognize and help the body destroy the cancer cells.
Men with biochemically recurrent (i.e. rising PSA in the absence of metastatic disease) prostate cancer after surgical removal of the prostate or radiation therapy of the prostate, and whose cancer has a mutation in a gene involved in repairing DNA damage (i.e. mismatch repair).
Participants will have tests and exams that are part of their standard care and for study purpose. Infusion of the study drug will be given every 4 weeks. Treatment will be continued until PSA progression or disease progression, unmanageable bad reaction to the study drug, or a total duration of 2 years of nivolumab treatment.
08/11/2020 05:02 AM