Back to resultsA Study of SHR-1701 Plus Platinum-containing Chemotherapy With or Without BP102 (Bevacizumab) as First-line Treatment in Cervical Cancer
Primary Purpose
Cervical Cancer
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
SHR-1701 + paclitaxel + cisplatin/carboplatin + BP102
SHR-1701 + paclitaxel + cisplatin/carboplatin± BP102
Placebo + paclitaxel + cisplatin/carboplatin ± BP102
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Cancer
Eligibility Criteria
Inclusion Criteria:
- Aged 18-70 years, female.
- With Eastern Cooperative Oncology Group (ECOG) performance status scores of 0-1.
- With a life expectancy of ≥ 12 weeks.
- Acute toxicities from prior anti-tumor treatments must have resolved to Grade 0-1 (per NCI CTCAE 5.0).
- With at least one measurable lesion as per RECIST v1.1.
- With histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix.
- Persistent, recurrent, or metastatic cervical cancer.
- Patients to be enrolled in Stage II are required to provide a minimum of 10 slides of fresh (preferred).
- Women of childbearing potential must have a negative serum pregnancy test within 3 days prior to starting study treatment.
- Patients must agree and have signed the informed consent form.
Exclusion Criteria:
- With known contraindications to paclitaxel, cisplatin, or carboplatin.
- With known allergies to any of the study drugs or their excipients; severe allergic reactions to other monoclonal antibodies.
- With inadequately treated CNS metastasis.
- With uncontrolled hypertension.
- With uncontrolled cardiac diseases or symptoms.
- With major vascular disease.
- With arterial/venous thrombotic events within 6 months prior to randomization.
- Have received full-dose anticoagulant or hemolytic therapy within 10 days prior to randomization.
- With clinically significant hemorrhage or definitive bleeding diathesis within 3 months prior to randomization.
- With severe, unhealed, or open wounds as well as active ulcers or untreated fractures.
- With any active autoimmune disease or a history of autoimmune disease that is expected to recur.
- Had other active malignant tumors within 5 years prior to study enrolment.
- With congenital or acquired immunodeficiency (such as HIV-infected patients).
Sites / Locations
- Sun Yat-sen University Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
SHR-1701 + paclitaxel + cisplatin/carboplatin + BP102
SHR-1701 + paclitaxel + cisplatin/carboplatin ± BP102
Placebo + paclitaxel + cisplatin/carboplatin ± BP102
Arm Description
Outcomes
Primary Outcome Measures
Incidence and severity of Participants Who Experience an Adverse Event (AE) as per NCI-CTC AE 5.0（Stage I）
Incidence and severity of Participants Who Experience a Serious AE (SAE) as per NCI-CTC AE 5.0（Stage I）
Incidence and severity of Participants Who Experience an Immune-related AE (irAE) as per NCI-CTC AE 5.0（Stage I）
BIRC-assessed progression-free survival (PFS) as per RECIST v1.1（Stage II）
OS is defined as the time from randomization to death due to any cause. （Stage II）
Secondary Outcome Measures
Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by Investigator （Stage I）
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator （Stage I）
Disease Control Rate (DCR)up to approximately 26 months（Stage I）
Duration of Response (DOR) Per RECIST 1.1 as Assessed by Investigator （Stage I）
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).
Overall survival (OS) up to approximately 26 months（Stage I）
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）
Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BIRC- and investigator（Stage II）
Disease Control Rate (DCR)Per RECIST 1.1 as Assessed by BIRC- and investigator（Stage II）
Duration of Response (DOR) Per RECIST 1.1 as Assessed by BIRC- and investigator （Stage II）
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).
Incidence and severity of Participants Who Experience an Adverse Event (AE) as per NCI-CTC AE 5.0 （Stage II）
Incidence and severity of Participants Who Experience a Serious AE (SAE) as per NCI-CTC AE 5.0（Stage II）
Incidence and severity of Participants Who Experience an Immune-related AE (irAE) as per NCI-CTC AE 5.0（Stage II）
Full Information
NCT ID
NCT05179239
First Posted
October 14, 2021
Last Updated
March 13, 2022
Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05179239
Brief Title
A Study of SHR-1701 Plus Platinum-containing Chemotherapy With or Without BP102 (Bevacizumab) as First-line Treatment in Cervical Cancer
Official Title
A Randomized，Double-blind，Controlled，Multi-center Phase III Clinical Study Evaluating 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
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
February 26, 2022 (Actual)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
May 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
SHR-1701 or Placebo Plus Chemotherapy With or Without BP102 (Bevacizumab)
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
572 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SHR-1701 + paclitaxel + cisplatin/carboplatin + BP102
Arm Type
Experimental
Arm Title
SHR-1701 + paclitaxel + cisplatin/carboplatin ± BP102
Arm Type
Experimental
Arm Title
Placebo + paclitaxel + cisplatin/carboplatin ± BP102
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SHR-1701 + paclitaxel + cisplatin/carboplatin + BP102
Intervention Description
SHR-1701 + paclitaxel + cisplatin/carboplatin + BP102
Intervention Type
Drug
Intervention Name(s)
SHR-1701 + paclitaxel + cisplatin/carboplatin± BP102
Intervention Description
SHR-1701 + paclitaxel + cisplatin/carboplatin± BP102
Intervention Type
Drug
Intervention Name(s)
Placebo + paclitaxel + cisplatin/carboplatin ± BP102
Intervention Description
Placebo + paclitaxel + cisplatin/carboplatin ± BP102
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
BIRC-assessed progression-free survival (PFS) as per RECIST v1.1（Stage II）
Time Frame
Up to approximately 10 months
Title
OS is defined as the time from randomization to death due to any cause. （Stage II）
Time Frame
Up to approximately 26 months
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by Investigator （Stage I）
Time Frame
Up to approximately 26 months
Title
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
Title
Disease Control Rate (DCR)up to approximately 26 months（Stage I）
Time Frame
up to approximately 26 months
Title
Duration of Response (DOR) Per RECIST 1.1 as Assessed by Investigator （Stage I）
Time Frame
Up to approximately 26 months
Title
Time to Progress(TTP) up to approximately 26 months（Stage I）
Description
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
Title
Overall survival (OS) up to approximately 26 months（Stage I）
Time Frame
up to approximately 26 months
Title
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
Title
Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BIRC- and investigator（Stage II）
Time Frame
Up to approximately 26 months
Title
Disease Control Rate (DCR)Per RECIST 1.1 as Assessed by BIRC- and investigator（Stage II）
Time Frame
Up to approximately 26 months
Title
Duration of Response (DOR) Per RECIST 1.1 as Assessed by BIRC- and investigator （Stage II）
Time Frame
Up to approximately 26 months
Title
Time to Progress(TTP) up to approximately 26 months （Stage II）
Description
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
Title
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
Title
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
Title
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.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 18-70 years, female.
With Eastern Cooperative Oncology Group (ECOG) performance status scores of 0-1.
With a life expectancy of ≥ 12 weeks.
Acute toxicities from prior anti-tumor treatments must have resolved to Grade 0-1 (per NCI CTCAE 5.0).
With at least one measurable lesion as per RECIST v1.1.
With histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix.
Persistent, recurrent, or metastatic cervical cancer.
Patients to be enrolled in Stage II are required to provide a minimum of 10 slides of fresh (preferred).
Women of childbearing potential must have a negative serum pregnancy test within 3 days prior to starting study treatment.
Patients must agree and have signed the informed consent form.
Exclusion Criteria:
With known contraindications to paclitaxel, cisplatin, or carboplatin.
With known allergies to any of the study drugs or their excipients; severe allergic reactions to other monoclonal antibodies.
With inadequately treated CNS metastasis.
With uncontrolled hypertension.
With uncontrolled cardiac diseases or symptoms.
With major vascular disease.
With arterial/venous thrombotic events within 6 months prior to randomization.
Have received full-dose anticoagulant or hemolytic therapy within 10 days prior to randomization.
With clinically significant hemorrhage or definitive bleeding diathesis within 3 months prior to randomization.
With severe, unhealed, or open wounds as well as active ulcers or untreated fractures.
With any active autoimmune disease or a history of autoimmune disease that is expected to recur.
Had other active malignant tumors within 5 years prior to study enrolment.
With congenital or acquired immunodeficiency (such as HIV-infected patients).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Linna Wang, MD
Phone
021-68868570
Email
linna.wang@hengrui.com
First Name & Middle Initial & Last Name or Official Title & Degree
Junshuang Diao
Phone
17721286512
Email
Junshuang.diao@hengrui.com
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jihong Liu, Professor
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Study of SHR-1701 Plus Platinum-containing Chemotherapy With or Without BP102 (Bevacizumab) as First-line Treatment in Cervical Cancer
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