castration-resistant prostate cancer
Conditions
Brief summary
disease control rate (DCR) of >6mo; this includes SD, PR or CR by best ORR in evaluable patients, all lasting longer than 6 months
Detailed description
Safety (first secondary endpoint): - Percentage of Grade 3/4 and 5 treatment-related AE's Efficacy (second secondary endpoint): - Best objective response rate (ORR) per RECIST1 .1 criteria - Biochemica! response rate at week 13 and maxi mal PSA decline according to Prostate Cancer Working Group 3 criteria (PCWG3) - Radiographic progression free survival per irRECIST1 .1 immune-related response criteria
Interventions
DRUGYERVOY 5 mg/ml concentrate for solution for infusion
DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.
Sponsors
Stichting Radboud universitair medisch centrum
Eligibility
Sex/Gender
Male
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease control rate (DCR) of >6mo; this includes SD, PR or CR by best ORR in evaluable patients, all lasting longer than 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety (first secondary endpoint): - Percentage of Grade 3/4 and 5 treatment-related AE's Efficacy (second secondary endpoint): - Best objective response rate (ORR) per RECIST1 .1 criteria - Biochemica! response rate at week 13 and maxi mal PSA decline according to Prostate Cancer Working Group 3 criteria (PCWG3) - Radiographic progression free survival per irRECIST1 .1 immune-related response criteria | — |
Countries
Netherlands
Outcome results
None listed