A Study of SHR-1701 Plus Platinum-containing Chemotherapy With or Without BP102 (Bevacizumab) as First-line Treatment in Cervical Cancer

Cervical Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05179239
• Other study ID #: SHR-1701-III-309
• Status: Recruiting
• Phase: Phase 3
• Start date: February 26, 2022
• Est. completion date: May 2025

Study information

• Verified date: September 2021
• Source: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
• Contact: Linna Wang, MD
• Phone: 021-68868570
• Email: linna.wang[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 572
• Est. completion date: May 2025
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Aged 18-70 years, female.

2. With Eastern Cooperative Oncology Group (ECOG) performance status scores of 0-1.

3. With a life expectancy of = 12 weeks.

4. Acute toxicities from prior anti-tumor treatments must have resolved to Grade 0-1 (per NCI CTCAE 5.0).

5. With at least one measurable lesion as per RECIST v1.1.

6. With histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix.

7. Persistent, recurrent, or metastatic cervical cancer.

8. Patients to be enrolled in Stage II are required to provide a minimum of 10 slides of fresh (preferred).

9. Women of childbearing potential must have a negative serum pregnancy test within 3 days prior to starting study treatment.

10. Patients must agree and have signed the informed consent form.

Exclusion Criteria:

1. With known contraindications to paclitaxel, cisplatin, or carboplatin.

2. With known allergies to any of the study drugs or their excipients; severe allergic reactions to other monoclonal antibodies.

3. With inadequately treated CNS metastasis.

4. With uncontrolled hypertension.

5. With uncontrolled cardiac diseases or symptoms.

6. With major vascular disease.

7. With arterial/venous thrombotic events within 6 months prior to randomization.

8. Have received full-dose anticoagulant or hemolytic therapy within 10 days prior to randomization.

9. With clinically significant hemorrhage or definitive bleeding diathesis within 3 months prior to randomization.

10. With severe, unhealed, or open wounds as well as active ulcers or untreated fractures.

11. With any active autoimmune disease or a history of autoimmune disease that is expected to recur.

12. Had other active malignant tumors within 5 years prior to study enrolment.

13. With congenital or acquired immunodeficiency (such as HIV-infected patients).

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• SHR-1701 + paclitaxel + cisplatin/carboplatin + BP102
SHR-1701 + paclitaxel + cisplatin/carboplatin + BP102
• SHR-1701 + paclitaxel + cisplatin/carboplatin± BP102
SHR-1701 + paclitaxel + cisplatin/carboplatin± BP102
• Placebo + paclitaxel + cisplatin/carboplatin ± BP102
Placebo + paclitaxel + cisplatin/carboplatin ± BP102

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	BIRC-assessed progression-free survival (PFS) as per RECIST v1.1(Stage II)		Up to approximately 10 months
Primary	OS is defined as the time from randomization to death due to any cause. (Stage II)		Up to approximately 26 months
Secondary	Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by Investigator (Stage I)		Up to approximately 26 months
Secondary	Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator (Stage I)		Up to approximately 26 months
Secondary	Disease Control Rate (DCR)up to approximately 26 months(Stage I)		up to approximately 26 months
Secondary	Duration of Response (DOR) Per RECIST 1.1 as Assessed by Investigator (Stage I)		Up to approximately 26 months
Secondary	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
Secondary	Overall survival (OS) up to approximately 26 months(Stage I)		up to approximately 26 months
Secondary	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
Secondary	Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BIRC- and investigator(Stage II)		Up to approximately 26 months
Secondary	Disease Control Rate (DCR)Per RECIST 1.1 as Assessed by BIRC- and investigator(Stage II)		Up to approximately 26 months
Secondary	Duration of Response (DOR) Per RECIST 1.1 as Assessed by BIRC- and investigator (Stage II)		Up to approximately 26 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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.