The goal of this clinical trial is to evaluate the efficacy and safety of Socazolimab combined with chemotherapy with or without bevacizumab as first-Line treatment in persistent, recurrent, or metastatic cervical cancer. The main question it aims to answer is: Does Socazolimab combined with chemotherapy with or without bevacizumab better benefit patients with persistent, recurrent, or metastatic cervical cancer as first-line treatment compared with placebo combined with chemotherapy with or without bevacizumab. Participants will be treated with Socazolimab/placebo + chemotherapy ± bevacizumab) for 6\~8 cycles (Q3w), following maintenance treatment of Socazolimab/placebo (Q3w).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
440
6\~8 cycles of Socazolimab (5 mg/kg) + cisplatin (50 mg/m2) /carboplatin (AUC5) + paclitaxel (175 mg/m2) ± Bevacizumab (15 mg/kg), Q3w. Followed with Socazolimab (5 mg/kg), Q3w.
6\~8 cycles of placebo (5 mg/kg) + cisplatin (50 mg/m2) /carboplatin (AUC5) + paclitaxel (175 mg/m2) ± Bevacizumab (15 mg/kg), Q3w. Followed with placebo (5 mg/kg), Q3w.
Anhui Provincial Cancer Hospital
Hefei, Anhui, China
RECRUITINGCancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGHunan Cancer Hospital
Changsha, Hunan, China
RECRUITINGZhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGOverall survival
Time frame: From date of randomization to date of death from any cause, assessed up to 100 months.
PFS (assessed by BICR, based on RECIST v1.1)
Time frame: From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
ORR (assessed by BICR, based on RECIST v1.1)
Time frame: From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
DoR (assessed by BICR, based on RECIST v1.1)
Time frame: From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
DCR (assessed by BICR, based on RECIST v1.1)
Time frame: From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
TTR (assessed by BICR, based on RECIST v1.1)
Time frame: From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
PFS (assessed by investigators, based on RECIST v1.1)
Time frame: From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
ORR (assessed by investigators, based on RECIST v1.1)
Time frame: From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
DoR (assessed by investigators, based on RECIST v1.1)
Time frame: From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
DCR (assessed by investigators, based on RECIST v1.1)
Time frame: From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
TTR (assessed by investigators, based on RECIST v1.1)
Time frame: From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.
Safety: adverse events, clinical abnormalties
Time frame: from written informed concent to 90 days after last dose
Tmax
Time frame: from 30min before first dose to 30 days after last dose
Cmax
Time frame: from 30min before first dose to 30 days after last dose
T1/2
Time frame: from 30min before first dose to 30 days after last dose
Immunogenicity
ADA, NAb
Time frame: from 30min before first dose to 30 days after last dose
Health-related quality of life (HRQoL)
using EORTC QLQ-C30 Questionnaire
Time frame: from screening to end of treatment visit, up to 100 months
PD-L1 status
Time frame: up to 100 months
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