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Sponsor develops strategy adjustment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1701 + paclitaxel + cisplatin/carboplatin + BP102 | Experimental |
| |
| SHR-1701 + paclitaxel + cisplatin/carboplatin ± BP102 | Experimental |
| |
| Placebo + paclitaxel + cisplatin/carboplatin ± BP102 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1701 + paclitaxel + cisplatin/carboplatin + BP102 | Drug | SHR-1701 + paclitaxel + cisplatin/carboplatin + BP102 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of Participants Who Experience an Adverse Event (AE) as per NCI-CTC AE 5.0（Stage I） | 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） | 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） | Up to approximately 21 days | |
| BIRC-assessed progression-free survival (PFS) as per RECIST v1.1（Stage II） | Up to approximately 10 months | |
| OS is defined as the time from randomization to death due to any cause. （Stage II） | Up to approximately 26 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by Investigator （Stage I） | 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） |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35653122 | Derived | Feng J, Tang D, Wang J, Zhou Q, Peng J, Lou H, Sun Y, Cai Y, Chen H, Yang J, Liu P, Wang L, Zou J. SHR-1701, a Bifunctional Fusion Protein Targeting PD-L1 and TGFbeta, for Recurrent or Metastatic Cervical Cancer: A Clinical Expansion Cohort of a Phase I Study. Clin Cancer Res. 2022 Dec 15;28(24):5297-5305. doi: 10.1158/1078-0432.CCR-22-0346. |
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SHR-1701 or Placebo Plus Chemotherapy With or Without BP102 (Bevacizumab)
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| SHR-1701 + paclitaxel + cisplatin/carboplatin± BP102 | Drug | SHR-1701 + paclitaxel + cisplatin/carboplatin± BP102 |
|
| Placebo + paclitaxel + cisplatin/carboplatin ± BP102 | Drug | Placebo + paclitaxel + cisplatin/carboplatin ± BP102 |
|
| Up to approximately 26 months |
| Disease Control Rate (DCR)up to approximately 26 months（Stage I） | up to approximately 26 months |
| Duration of Response (DOR) Per RECIST 1.1 as Assessed by Investigator （Stage I） | Up to approximately 26 months |
| 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). | up to approximately 26 months |
| Overall survival (OS) up to approximately 26 months（Stage I） | 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） | Up to approximately 26 months |
| Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BIRC- and investigator（Stage II） | Up to approximately 26 months |
| Disease Control Rate (DCR)Per RECIST 1.1 as Assessed by BIRC- and investigator（Stage II） | Up to approximately 26 months |
| Duration of Response (DOR) Per RECIST 1.1 as Assessed by BIRC- and investigator （Stage II） | 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). | 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） | 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） | 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） | Up to approximately 26 months. |
| 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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| ID | Term |
|---|---|
| C000723862 | SHR-1701 |
| D017239 | Paclitaxel |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
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