This is a randomized, placebo-controlled, multi-center, double blinded, Phase III study to determine the efficacy and safety of TORIPALIMAB INJECTIO（JS001） in combination with gemcitabine/cisplatin compared with placebo in combination with gemcitabine/cisplatin as first-line treatment in patients with histological/cytological confirmation of recurrent or metastatic NPC. The primary endpoint is PFS in all patients. Approximately 280 patients who fulfill all of the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to one of the two treatment arms. patients will be randomly assigned to the combination of JS001 (Arm A) or placebo (Arm B) with gemcitabine and cisplatin given every 3 weeks (Q3W) in 3-week cycles.
Total 289 patients were enrolled and randomized in a 1:1 ratio to the group of JS001 (Arm A) with gemcitabine and cisplatin or placebo (Arm B) with gemcitabine and cisplatin every 3 weeks (Q3W) in the 'during chemotherapy' phase. During the 'post-chemotherapy' phase, patients randomized to Arm A or Arm B will continue treatment with JS001 or placebo as maintenance therapy Q3W until excessive toxicity or progressive disease, withdrawal of consent or Investigator's judgement or a maximum of 2 years. Tumor evaluation scans will be performed at screening (as baseline) then every 6weeks in the first 12 months then every 9 weeks thereafter until objective disease progression. The primary objective is to compare PFS as assessed by the IRC in ITT population (all randomized patients).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
289
TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
placebo combine with chemotherapy
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Guangzhou, Guangdong, China
IRC-assessed Progression-Free Survival (PFS) According to RECIST v1.1
To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy as measured by IRC-assessed progression free survival (PFS) according to RECIST v1.1 in all patients. The definition of Progressive Disease: At least a 20% increasein the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. or the appearance of one or more new lesions is also considered progression.
Time frame: up to 2 years
OS
Overall survival was defined as the time from randomization to death from any cause.
Time frame: The time frame of OS collected is upto about 48months.
Investigator-assessed ORR According to RECIST v1.1
To evaluate the efficacy of TORIPALIMAB INJECTION(JS001) plus chemotherapy compared with placebo plus chemotherapy, as measured by investigator-assessed overall response rate (ORR) according to RECIST v1.1.
Time frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
Investigator-assessed DoR According to RECIST v1.1
To evaluate the efficacy of TORIPALIMAB INJECTION(JS001 )plus chemotherapy compared with placebo plus chemotherapy, as measured by investigator-assessed duration of response (DoR) according to RECIST v1.1.
Time frame: From date of response until progressive disease. Up to 2 approximately years
Investigator-assessed DCR According to RECIST v1.1
To evaluate the efficacy of TORIPALIMAB INJECTION(JS001) plus chemotherapy compared with placebo plus chemotherapy, as measured by investigator-assessed disease control rate (DCR) according to RECIST v1.1.
Time frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
Investigator-assessed PFS According to RECIST v1.1
To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy, as measured by Investigators-assessed PFS according to RECIST v1.1
Time frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
Investigator-assessed PFS Rate at 1 Year
To evaluate the PFS rate at 1 year in each treatment arm by investigator
Time frame: up to approximately 1years
OS Rate at 1 Year
To evaluate the OS rate at 1 year in each treatment arm
Time frame: Up to approximately 1 years
IRC-assessed ORR According to RECIST v1.1
health related quality of life (HRQoL) in patients treated with JS001 plus chemotherapy compared with placebo plus chemotherapy using the EORTC QLQ-H\&N35
Time frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
IRC-assessed DoR According to RECIST v1.1
To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy, as measured by IRC-assessed duration of response (DoR) according to RECIST v1.1.
Time frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
IRC-assessed DCR According to RECIST v1.1
To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy, as measured by IRC-assessed disease control rate (DCR) according to RECIST v1.1.
Time frame: From date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately years
Number of Participants Experiencing an Adverse Event(AE)
Incidence of adverse events(AE) as assessed by CTCAE version 5.0
Time frame: From date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately years
Anti-drug Antibody(ADA)
To evaluate the incidence of ADAs against JS001
Time frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
PFS IRC-assessed Per irRECIST
To evaluate PFS of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.
Time frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
ORR IRC-assessed Per irRECIST
To evaluate ORR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.
Time frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
DoR IRC-assessed Per irRECIST
To evaluate DoR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.
Time frame: From date of response until progressive disease. Up to 2 approximately years
DCR IRC-assessed Per irRECIST
To evaluate DCR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.
Time frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
Investigator-assessed PFS Rate at 2 Years
To evaluate the PFS rate at 2 years in each treatment arm by investigator
Time frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
OS Rate at 2 Years
To evaluate the OS rate at 2 years in each treatment arm
Time frame: Up to approximately 2 years
PFS Investigator-assessed Per irRECIST
To evaluate PFS of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.
Time frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
ORR Investigator-assessed Per irRECIST
To evaluate ORR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.
Time frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
DoR Investigator-assessed Per irRECIST
To evaluate DoR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.
Time frame: From date of response until progressive disease. Up to 2 approximately years
DCR Investigator-assessed Per irRECIST
To evaluate DCR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.
Time frame: Up to approximately 42 months
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