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

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

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 Overview

• Status: Terminated
• Conditions: Cervical Cancer
• Intervention / Treatment: Drug: SHR-1701 + paclitaxel + cisplatin/carboplatin + BP102; Drug: SHR-1701 + paclitaxel + cisplatin/carboplatin± BP102; Drug: Placebo + paclitaxel + cisplatin/carboplatin ± BP102

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Sun Yat-sen University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-1701 + paclitaxel + cisplatin/carboplatin + BP102	Drug: SHR-1701 + paclitaxel + cisplatin/carboplatin + BP102; SHR-1701 + paclitaxel + cisplatin/carboplatin + BP102
Experimental: SHR-1701 + paclitaxel + cisplatin/carboplatin ± BP102	Drug: SHR-1701 + paclitaxel + cisplatin/carboplatin± BP102; SHR-1701 + paclitaxel + cisplatin/carboplatin± BP102
Placebo Comparator: Placebo + paclitaxel + cisplatin/carboplatin ± BP102	Drug: Placebo + paclitaxel + cisplatin/carboplatin ± BP102; Placebo + paclitaxel + cisplatin/carboplatin ± BP102

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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）		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.

Collaborators and Investigators

• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2022
• Primary Completion (Actual): August 12, 2024
• Study Completion (Actual): August 12, 2024

Study Registration Dates

• First Submitted: October 14, 2021
• First Submitted That Met QC Criteria: December 20, 2021
• First Posted (Actual): January 5, 2022

Study Record Updates

• Last Update Posted (Actual): April 15, 2025
• Last Update Submitted That Met QC Criteria: April 10, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Uterine Cervical Neoplasms; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel; Cisplatin
• Other Study ID Numbers: SHR-1701-III-309

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No