The purpose of this study is to evaluate the efficacy (clinical benefit rate) of MVA EBNA1/LMP2 vaccine in patients with persistent, recurrent or metastatic nasopharyngeal carcinoma, and its impact on disease progression.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong, Hong Kong
Clinical Benefit Rate
Clinical benefit rate (CBR, percent of patients experiencing complete response \[CR\], partial response \[PR\] or stable disease \[SD\] for at least 12 weeks from post cycle 2 to cycle 6 measurements) determined according to the Response Evaluation Criteria in Solid Tumours (RECIST), or by immune-related Response criteria (irRC) in the absence of measurable disease.
Time frame: 2 Years
Objective Response Rate (ORR)
ORR is defined as the proportion of patients with confirmed complete response (CR) or confirmed partial response (PR) from post cycle 2 to cycle 6 measurements according to the Response Evaluation Criteria in Solid Tumours (RECIST), relative to the total evaluable patient population.
Time frame: 2 Years
Duration of Response (DR)
DR is defined as the time from the first documentation of objective tumour response to the first documentation of objective tumour progression or to death due to any cause.
Time frame: 2 Years
Progression-free survival (PFS)
PFS is defined as the time from post cycle 2 measurement to first documentation of objective tumour progression, or to death due to any cause.
Time frame: 3 Years
Overall survival (OS)
Overall survival (OS) is defined as the time from start of study treatment to date of death due to any cause.
Time frame: 3 Years
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