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

NCT05179239 | Terminated Phase 3

• 1 other identifier: SHR-1701-III-309
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (14)

• 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）

  up to approximately 26 months

Study Arms (3)

SHR-1701 + paclitaxel + cisplatin/carboplatin + BP102

EXPERIMENTAL

Drug: SHR-1701 + paclitaxel + cisplatin/carboplatin + BP102

SHR-1701 + paclitaxel + cisplatin/carboplatin ± BP102

EXPERIMENTAL

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

Placebo + paclitaxel + cisplatin/carboplatin ± BP102

PLACEBO COMPARATOR

Drug: Placebo + paclitaxel + cisplatin/carboplatin ± BP102

Interventions

SHR-1701 + paclitaxel + cisplatin/carboplatin± BP102 DRUG

SHR-1701 + paclitaxel + cisplatin/carboplatin± BP102

SHR-1701 + paclitaxel + cisplatin/carboplatin ± BP102

Placebo + paclitaxel + cisplatin/carboplatin ± BP102 DRUG

Placebo + paclitaxel + cisplatin/carboplatin ± BP102

Placebo + paclitaxel + cisplatin/carboplatin ± BP102

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

Location

Related Publications (1)

• 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.

  PMID: 35653122 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

SHR-1701; Paclitaxel; Cisplatin; Carboplatin

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SHR-1701 or Placebo Plus Chemotherapy With or Without BP102 (Bevacizumab)

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: January 5, 2022
• Study Start: February 26, 2022
• Primary Completion: August 12, 2024
• Study Completion: August 12, 2024
• Last Updated: April 15, 2025

Record last verified: 2025-04

Locations

CN (1)