Phase III Study of Socazolimab as First-Line Treatment in Persistent, Recurrent, or Metastatic Cervical Cancer
NCT Number: NCT06459687
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Cervical Cancer
Interventions: DRUG: Socazolimab+cisplatin/carboplatin+paclitaxel+Bevacizumab|DRUG: Placebo+cisplatin/carboplatin+paclitaxel+Bevacizumab
Sponsor: Lee's Pharmaceutical Limited
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 440
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2028-09-01

Summary:
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).

Primary Outcome Measures: Overall survival, From date of randomization to date of death from any cause, assessed up to 100 months.
Secondary Outcome Measures: PFS (assessed by BICR, based on RECIST v1.1), 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), 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), 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), 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), 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), 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), 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), 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), 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), 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, from written informed concent to 90 days after last dose|Tmax, from 30min before first dose to 30 days after last dose|Cmax, from 30min before first dose to 30 days after last dose|T1/2, from 30min before first dose to 30 days after last dose|Immunogenicity, ADA, NAb, from 30min before first dose to 30 days after last dose|Health-related quality of life (HRQoL), using EORTC QLQ-C30 Questionnaire, from screening to end of treatment visit, up to 100 months|PD-L1 status, up to 100 months