This is a multi-center, randomized, open-label, phase II study to evaluate the efficacy and safety of anti-PD-1 antibody Penpulimab (AK105) combined with chemotherapy ± anlotinib hydrochloride in the first-line treatment of patients with advanced nasopharyngeal carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Cancer Hospital of the University of Chinese Academy of Sciences
Hangzhou, Zhejiang, China
Objective response rate (ORR)
ORR is the proportion of subjects with CR or PR based on RECIST v1.1.
Time frame: up to 2 years
Progression-free survival (PFS)
PFS is defined as the time from the date of randomization till the first documentation of disease progression (per RECIST v1.1 criteria) or death from any cause (whichever occurs first).
Time frame: up to 2 years
Disease control rate (DCR)
DCR is defined as the proportion of subjects with CR, PR, or SD, based on RECIST v1.1.
Time frame: up to 2 years
Duration of response (DoR)
DoR is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
Time frame: up to 2 years
Overall survival (OS)
OS is defined as the time from the date of randomization to death from any cause.
Time frame: up to 2 years
Observed concentrations of AK105
The endpoints for assessment of PK of AK105 include serum concentrations of AK105 at different timepoints after AK105 administration.
Time frame: From first dose of AK105 through 90 days after last dose of AK105.
Number of subjects who develop detectable anti-drug antibodies (ADAs)
The immunogenicity of AK105 will be assessed by summarizing the number of subjects who develop detectable antidrug antibodies (ADAs).
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Oral administration
Time frame: From first dose of AK105 through 90 days after last dose of AK105.