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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Socazolimab+Chemotherapy±Bevacizumab | Experimental | 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. |
|
| Placebo+Chemotherapy±Bevacizumab | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Socazolimab+cisplatin/carboplatin+paclitaxel+Bevacizumab | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | From date of randomization to date of death from any cause, assessed up to 100 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Cancer Hospital | Recruiting | Hefei | Anhui | 230031 | China |
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| Placebo+cisplatin/carboplatin+paclitaxel+Bevacizumab | Drug | 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. |
|
| 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 |
| Cancer Hospital Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100021 | China |
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| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430022 | China |
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| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | 410013 | China |
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| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310022 | China |
|
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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