The purpose of this study is to evaluate the efficacy and safety of SL-T10 and GX-I7 or SL-T10, GX-I7 and pembrolizumab in patients with metastatic castration-resistant prostate cancer (mCRPC).
The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of SL-T10, GX-I7, and pembrolizumab in combination in patients with metastatic castration-resistant prostate cancer (mCRPC).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
78
A therapeutic DNA vaccine containing three prostate cancer-specific antigen genes and genetic adjuvants
A T-cell growth factor
An immune check point inhibitor
Seoul National University Hospital
Seoul, South Korea
RECRUITINGNumber of participants with treatment-emergent adverse events (TEAEs)
Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: Baseline to 23 weeks
Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0
Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0
Time frame: Baseline to 48 weeks
PSA response rate
% patients with a reduction in PSA level from baseline by 50% or greater
Time frame: Baseline to 48 weeks
PSA progression free survival
The interval from the date of randomisation to the date of first evidence of PSA progression or death from any cause, whichever occurred first.
Time frame: Baseline to 48 weeks
Radiographic progression free survival
The interval from the date of disease progression on CT and/or Tc bone scan or death from any cause, whichever occurred first.
Time frame: Baseline to 48 weeks
Change of induced T-cell responses for SL-T10 vaccine
Vaccine-induced T-cell responses assessed by immunoassays in peripheral blood
Time frame: Baseline to 48 weeks
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