The study is being conducted to evaluate the efficacy, and safety of SHR-1701 or Placebo Plus Chemotherapy With or Without BP102 (Bevacizumab) as First-Line Treatment in Patients With Persistent, Recurrent, or Metastatic Cervical Cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
31
SHR-1701 + paclitaxel + cisplatin/carboplatin + BP102
SHR-1701 + paclitaxel + cisplatin/carboplatin± BP102
Placebo + paclitaxel + cisplatin/carboplatin ± BP102
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Incidence and severity of Participants Who Experience an Adverse Event (AE) as per NCI-CTC AE 5.0(Stage I)
Time frame: Up to approximately 21 days
Incidence and severity of Participants Who Experience a Serious AE (SAE) as per NCI-CTC AE 5.0(Stage I)
Time frame: Up to approximately 21 days
Incidence and severity of Participants Who Experience an Immune-related AE (irAE) as per NCI-CTC AE 5.0(Stage I)
Time frame: Up to approximately 21 days
BIRC-assessed progression-free survival (PFS) as per RECIST v1.1(Stage II)
Time frame: Up to approximately 10 months
OS is defined as the time from randomization to death due to any cause. (Stage II)
Time frame: Up to approximately 26 months
Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by Investigator (Stage I)
Time frame: Up to approximately 26 months
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator (Stage I)
Time frame: Up to approximately 26 months
Disease Control Rate (DCR)up to approximately 26 months(Stage I)
Time frame: up to approximately 26 months
Duration of Response (DOR) Per RECIST 1.1 as Assessed by Investigator (Stage I)
Time frame: Up to approximately 26 months
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Time to Progress(TTP) up to approximately 26 months(Stage I)
The time from the date of the first medication to the date of the first recording of tumor progression (as measured according to THE RECIST v1.1 criteria, regardless of whether treatment is continued or not).
Time frame: up to approximately 26 months
Overall survival (OS) up to approximately 26 months(Stage I)
Time frame: up to approximately 26 months
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by BIRC- and investigator(Stage II)
Time frame: Up to approximately 26 months
Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BIRC- and investigator(Stage II)
Time frame: Up to approximately 26 months
Disease Control Rate (DCR)Per RECIST 1.1 as Assessed by BIRC- and investigator(Stage II)
Time frame: Up to approximately 26 months
Duration of Response (DOR) Per RECIST 1.1 as Assessed by BIRC- and investigator (Stage II)
Time frame: Up to approximately 26 months
Time to Progress(TTP) up to approximately 26 months (Stage II)
The time from the date of randomization to the date of the first recording of tumor progression (as measured according to THE RECIST v1.1 criteria, regardless of whether treatment is continued or not).
Time frame: up to approximately 26 months
Incidence and severity of Participants Who Experience an Adverse Event (AE) as per NCI-CTC AE 5.0 (Stage II)
Time frame: Up to approximately 26 months
Incidence and severity of Participants Who Experience a Serious AE (SAE) as per NCI-CTC AE 5.0(Stage II)
Time frame: Up to approximately 26 months
Incidence and severity of Participants Who Experience an Immune-related AE (irAE) as per NCI-CTC AE 5.0(Stage II)
Time frame: Up to approximately 26 months.