This would be a phase II prospective single arm mono-institutional study conducted in Queen Mary Hospital (Hong Kong) assessing the efficacy and safety of bintrafusp alfa in previously treated patients with recurrent and metastatic (R/M) non-keratinizing nasopharyngeal carcinoma (NPC).
All the patients must be registered with the Investigator(s) prior to initiation of treatment. The registration desk will confirm all eligibility criteria and obtain essential information (including patient number). Patients shall receive Bintrafusp alfa treatment through intravenous therapy every two weeks up until disease progression, unacceptable toxicity or for a maximum of 2 years. Survival Follow-up till 2 years will also be performed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Bintrafusp alfa will be administered intravenously every 2 weeks
Queen Mary Hospital
Hong Kong, Hong Kong
Evaluation of Objective Tumour Response
To evaluate the objective tumor response (ORR) to bintrafusp alfa in previously treated R/M NPC patients per response evaluation criteria of solid tumor (RECIST) version 1.1
Time frame: From the date of screening to radiographically documented progression according to RECIST 1.1, assessed up to 2 years
Progression-Free survival assessment
To assess the progression-free survival (PFS) per RECIST version 1.1
Time frame: From the date of screening to radiographically documented progression according to RECIST 1.1, assessed up to 2 years
Time-to-progression (TTP) assessment
To assess the time-to-progression (TTP) per RECIST version 1.1
Time frame: From the date of screening to radiographically documented progression according to RECIST 1.1, assessed up to 2 years
Median Survival
To assess the median survival
Time frame: From the date of screening to radiographically documented progression according to RECIST 1.1, assessed up to 2 years
Toxicity and Tolerability measurement
To measure the toxicities and tolerability in previously treated R/M NPC patients receiving bintrafusp alfa with the most updated version of CTCAE criteria
Time frame: From the date of screening to radiographically documented progression according to RECIST 1.1, assessed up to 2 years
Objective Response Rate (ORR)
To evaluate ORR, PFS and TTP per immune-related RECIST (irRECIST)
Time frame: From the date of screening to radiographically documented progression according to irRECIST, assessed up to 2 years
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Survival rate assessment
To measure the survival rate in 12 months and 24 months
Time frame: From the date of screening to radiographically documented progression according to RECIST 1.1, assessed up to 2 years
Duration of Response (DOR) evaluation
To evaluate the duration of response (DOR) in previously treated R/M NPC patients receiving bintrafusp alfa
Time frame: From the date of screening to radiographically documented progression according to RECIST 1.1, assessed up to 2 years
Investigate the relationship between the response to bintrafusp alfa and plasma Epstein-Barr virus (EBV) deoxyribonucleic acid (DNA) level
EBV-DNA will be determined using real-time quantitative polymerase chain reaction and the clearance (half-life) during the first 4 weeks of bintrafusp alfa will be measured. The half-life will be correlated with patients ORR, PFS, and OS
Time frame: From the date of screening to radiographically documented progression according to RECIST 1.1, assessed up to 2 years
Disease Control Rate (DCR)
Defined as the percentage of patients with a CR, PR, or SD ≥ 6 months per RECIST 1.1
Time frame: From the date of screening to radiographically documented progression according to RECIST 1.1, assessed up to 2 years
Time to Response (TTR)
Defined as the duration to first documented tumor response
Time frame: From the date of screening to first radiographically documented tumor response according to RECIST 1.1, assessed up to 2 years
Quality of Life (QoL)
To evaluate via the patient-reported EORTC-QLQ-C30 and H\&N-35 questionnaires
Time frame: Every 12 weeks from the date of screening in the first year of study enrolment