A Phase 3, Randomized Open-label Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Participants with Metastatic Castrationresistant Prostate Cancer (mCRPC) Who are Unselected for Homologous Recombination Repair Defects and Have Failed Prior Treatment with One Next-generation Hormonal Agent (NHA) and Chemotherapy (KEYLYNK-010)
Johns Hopkins Kimmel Cancer Center in Baltimore
To determine whether the combination of pembrolizumab plus Olaparib is superior to abiraterone acetate or enzalutamide with respect to overall survival.
Male patients 18 years of age and older with a histological confirmation of metastatic castration-resistant prostate cancer. Patient must have confirmed progression while receiving androgen deprivation therapy within 6 months prior to screening as evidenced by either PSA and/or radiographic progression. Two consecutive rising PSA values greater than 1 ng/ml obtained more than one week apart satisfies the PSA progression requirement. Patients must have had prior treatment with either abiraterone or enzalutamide and one regimen of Docetaxel for metastatic castrate resistant prostate cancer. Fresh tissue biopsy obtained within 12 months of screening or archival tumor tissue samples required prior to enrollment (If there is not enough archival tissue from prior biopsy for biomarker analysis a mandatory biopsy is required).
This is an open label, unblinded, Phase III trial, randomized control trial with patients randomized to receive either Pembrolizumab plus Olaparib or Abiraterone /Enzalutamide. Patients randomized to ARM 1 will receive Pembrolizumab 200mg IV every 3 weeks plus Olaparib 300mg oral administration twice a day. Patients randomized to ARM 2 will receive either Abiraterone 1000 mg by mouth daily in combination with prednisone 5 mg by mouth twice a day, (if previously treated with Enzalutamide) OR Enzalutamide 160 mg by mouth daily, (if previously treated with Abiraterone).
08/08/2020 05:02 AM