Nivolumab in Biochemically Recurrent dMMR Prostate Cancer
Status:
Recruiting
Trial end date:
2025-01-01
Target enrollment:
Participant gender:
Summary
MMR-deficient cancers of any histologic type appear to be very sensitive to PD-1 blockade
with pembrolizumab, and similar data are also beginning to emerge for nivolumab and other
immune checkpoint inhibitors. Among the MMR-deficient cancers, the best antitumor responses
are often associated with high microsatellite instability (MSI-H status), higher tumor
mutational burden (TMB), and higher predicted neoantigen load. Prevalence estimates of MMR
deficiency across solid tumor types range from 1% to 20% depending on the type of malignancy.
In prostate cancer, 1-3% of unselected cases harbor MMR deficiency and/or microsatellite
instability.
For men who previously received definitive treatment for prostate cancer and subsequently
develop detectable prostate specific antigen (PSA) levels, the clinical state is known as
biochemically recurrent prostate cancer. The current standard of care treatment for patients
with biochemically recurrent prostate cancer is either surveillance or androgen deprivation
therapy (ADT). ADT has not been shown to provide a survival benefit in this setting, and the
decision to initiate ADT will depend on patient preference and perceived risks of the
disease. A non-hormonal therapy such as nivolumab would provide an alternative to ADT in
patients with biomarker selected (i.e. dMMR, MSI-H, high TMB, or CDK12-altered) biochemically
recurrent prostate cancer.
Phase:
Phase 2
Details
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins