This is a single-arm,open, multicenter, phase II clinical study of the efficacy and safety of human anti-PD-L1 monoclonal antibody Injection (LDP) in the treatment of urinary and male genital tumors.
This trial is a single arm, open, multicenter, Ⅱ period clinical research. Three cohorts were included, 127 subjects were enrolled (Cohort 1: about 60 subjects with surgically suitable muscular-invasive bladder cancer; Cohort 2: about 40 subjects with advanced Non-clear Cell Renal Carcinoma; Cohort 3: about 27 subjects with advanced penile carcinoma. After confirmation of inclusion, intravenous infusion of 10mg/kg human anti-PD-L1 monoclonal antibody injection (LDP) was given. The initial efficacy and safety of drugs in different tumor species in the cohort above will be observed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
127
All participants will receive treatment with LDP 10mg/kg once every two weeks, every 2 weeks will be a cycle. In Cort 1, surgical treatment will be performed within 2 weeks after the end of 3 cycles of treatment.
Dragonboat Biopharmaceutical,Co.,Ltd
Shanghai, Shanghai Municipality, China
RECRUITINGCase complete response (pCR)
The pCR is defined as the case complete response in Cohort 1 (muscular-infiltrating bladder cancer suitable for surgery)
Time frame: At the end of the cycle 3 of treatment (each cycle is 14 days).
Objective response rate (ORR)
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1 in Cohort 2 (Non-clear Cell Renal cell Carcinoma) and Cohort 3 (advanced penile carcinoma)
Time frame: From first dose of LDP through 21 days after last dose of LDP up to 2 years.
Recurrence-free survival (RFS)
Recurrence-free survival (RFS) is defined as the time from the start of surgery to the earliest evidence of recurrence.
Time frame: One year after surgery or disease progression or intolerant toxicity, up to 2 years.
Progression-free survival (PFS)
Progression-free survival (PFS) is defined as the time elapsed from the day the study drug was first administered until the first imaging assessment of disease progression (PD) or death from any cause.
Time frame: From first dose of LDP, up to 2 years.
Disease control rate (DCR)
Disease control rate (DCR) is defined as the proportion of the optimal time response of CR, PR, disease stable (SD) (i.e. CR+PR+SD) between initiation of the trial drug and withdrawal from the trial, as assessed according to RECIST1.1 criteria.
Time frame: From first dose of LDP, up to 2 years.
Duration of response (DOR)
The duration of response (DOR) is defined as the time from the beginning of the first tumor assessment as PR or CR to the first assessment as PD or death from any cause.
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Time frame: From first dose of LDP, up to 2 years.
Overall survival (OS)
Overall survival (OS) is defined as the time between the date of first use of the study drug and death from any cause.
Time frame: From first dose of LDP, up to 2 years.
Incidence of adverse events
Adverse events (AEs) refer to all adverse medical events that occur when subjects sign the informed consent, which may be manifested as symptoms, signs, diseases or abnormal laboratory tests, but not necessarily causally related to the investigational drug.
Time frame: From first dose of LDP through 30 days after last dose of LDP, up to 5 months.
Incidence of abnormal vital signs
Vital signs (including temperature, respiration, heart rate and blood pressure) can be measured. The time window for each vital sign measurement is ±10 minutes.
Time frame: From first dose of LDP through 30 days after last dose of LDP, up to 5 months.
Incidence of abnormal ECOG scores
ECOG physical strength rating is based on ECOG physical strength rating criteria.
Time frame: From first dose of LDP through 30 days after last dose of LDP, up to 5 months.
Incidence of abnormal laboratory tests results
Descriptive analysis of laboratory results for safety analysis.
Time frame: From first dose of LDP through 30 days after last dose of LDP, up to 5 months.
Incidence of abnormal physical examinations
Descriptive analysis of physical examination for safety analysis.
Time frame: From first dose of LDP through 30 days after last dose of LDP, up to 5 months.
anti-drug antibody (ADA)
Anti-drug antibody (ADA) is tested for immunogenicity assessment , titer and neutralizing antibody analysis were performed when ADA was positive, and immunocomplex (CIC) and complement analysis were performed.
Time frame: In Cohort 1: before administration ,before surgery; In Cohort 2, 3: before administration, up to 4 months.