This is a phase 1b/II, open label, multicenter study of IBI310 (Anti-CTLA4 mAb) in combination with Sintilimab in patients with recurrent/metastatic Nasopharyngeal Carcinoma that failed prior Anti-PD-1/PD-L1 therapy
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
(IBI310 3 mg/kg IV d1, Q3W combined with sintilimab 100 mg IV d1, Q3W) or( IBI310 1 mg/kg IV d1, Q3W combined with sintilimab 200 mg IV d1, Q3W) for up to 4 cycles, and then sintilimab 200 mg IV d1, Q3W until progressive disease, intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first.
(IBI310 3 mg/kg IV d1, Q3W combined with sintilimab 100 mg IV d1, Q3W) or( IBI310 1 mg/kg IV d1, Q3W combined with sintilimab 200 mg IV d1, Q3W) for up to 4 cycles, and then sintilimab 200 mg IV d1, Q3W until progressive disease, intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
ORR(Objective response rate)
Investigator evaluated ORR per RECIST V1.1
Time frame: Up to 2 years
DOR(Duration of Response)
defined as the time from the first documented objective response to the first documented progressive disease or death of any cause, whichever occurs first;
Time frame: Up to 2 years
PFS (Progress Free Survival)
defined as the time from randomization to the first documented progressive disease or death of any cause, whichever occurs first;
Time frame: Up to 2 years
OS (Overall Survival)
defined as the time from randomization to death of any cause in subjects without receiving any immunotherapy outside the study protocol for first-line treatment of advanced HCC;
Time frame: Up to 2 years
DCR(Disease control rate)
defined as the proportion of patients whose best response is CR, PR, and stable disease (SD) non-CR/non-PD
Time frame: Up to 2 years
TTR(Time to progress)
defined as the time from randomization to the first documented and confirmed objective response (CR or PR)
Time frame: Up to 2 years
TEAE(Treatment Emergent Adverse Event)/SAE(Serious Adverse Event)
Incidence and severity of treatment-emergent: which is evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, v5.0, 2017) grade;
Time frame: Up to 2 years
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Changes of Quality of life, according to EORTC QLQ-C30
According to EORTC QLQ-C30
Time frame: Up to 2 years
Changes of Quality of life, according to EORTC QLQ-H&N35
According to EORTC QLQ-H\&N35
Time frame: Up to 2 years
ADAs
The immunogenicity of IBI310 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs)
Time frame: Up to 2 years