This is a randomized, open, multicenter phase II/III trial to compare the efficacy and safety of QL1706 and carrilizumab combined with gemcitabine and cisplatin in first-line treatment of recurrent or metastatic nasopharyngeal carcinoma.
This is a randomized, open, multicenter phase II/III trial to compare the efficacy and safety of QL1706 and carrilizumab combined with gemcitabine and cisplatin in first-line treatment of recurrent or metastatic nasopharyngeal carcinoma. The study is divided into two parts. The first part is a phase II, single-arm study with an introductory safety phase, which is planned to enroll 30 subjects with nasopharyngeal carcinoma treated with first-line QL1706 in combination with gemcitabine and cisplatin. The primary objective of the first part is to evaluate the safety and tolerability of QL1706 combined with gemcitabine and cisplatin in the first-line treatment of patients with recurrent or metastatic nasopharyngeal carcinoma. The second part is a phase III randomized, controlled study. The study plans to enroll 430 subjects, who will be randomized in a 1:1 ratio to a trial group of QL1706 in combination with gemcitabine and cisplatin and a control group of carrilizumab in combination with gemcitabine and cisplatin. The primary objective of the second part was to compare the effectiveness of QL1706 with that of carrilizumab combined with gemcitabine and cisplatin, respectively, in the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
460
5 mg/kg#D1#Q3W IV, 4-6 cycles
200mg#D1#Q3W IV, 4-6 cycles
1000mg/m2#D1\&D8#Q3W IV, 4-6 cycles
Sun Yat-sen University Cancer Center
Guangzhou, Guangzhou, China
Progression free survival (PFS) -BICR
The PFS assessed by Blinded independent central review (BICR)
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months after the last QL1706 injection has been administered
PFS- Investigator
The PFS assessed by Investigator
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months after the last QL1706 injection has been administered
Objective remission rate (ORR)
The ORR assessed by BICR and Investigator
Time frame: Every 6 weeks, from the date of enrollment until the date of the last time that tumor imaging and assessment of disease has been done, assessed up to 72 weeks
Duration of remission (DOR)
The DOR assessed by BICR and Investigator
Time frame: Every 6 weeks, from the date of enrollment until the date of the last time that tumor imaging and assessment of disease has been done, assessed up to 72 weeks
Disease Control Rate (DCR)
The DCR assessed by BICR and Investigator
Time frame: Every 6 weeks, from the date of enrollment until the date of the last time that tumor imaging and assessment of disease has been done, assessed up to 72 weeks
Overall survival (OS)
Overall survival
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months after the last QL1706 injection has been administered
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80mg/m2#D1#Q3W IV, 4-6 cycles
12-month OS rate
12-month Overall survival rate
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months after the last QL1706 injection has been administered