A Phase II Clinical Study to Assess the Efficacy and Safety of IBI310 or Placebo Combined With Sintilimab for Advanced Cervical Cancer Subjects Who Have Failed or Cannot Tolerate First-line or Above Platinum-based Chemotherapy

NCT04590599 | Completed Phase 2

• 1 other identifier: CIBI310E201
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 2

Brief Summary

This is a randomized, double-blind, controlled, parallel-cohort Phase II clinical study, which is planned to enroll 220 subjects with advanced cervical cancer who have failed or cannot tolerate first-line or above platinum-based chemotherapy

Conditions

Advanced Cervical Cancer

Outcome Measures

Primary Outcomes (2)

• Objective response rate (ORR)

  Objective response rate (ORR) assessed by the Independent Radiological Review Committee (IRRC) according to the Response Evaluation Criteria in Solid Tumors (RECIST) V1.1

  Assessed week 6,week 12,week 18 ,and every 9 weeks (or every 12 weeks after 54 weeks of treatment) for duration of study participation which is estimated to be 24 months.

• Objective response rate (ORR)

  ORR assessed by the investigator according to the RECIST V1.1

  Assessed week 6,week 12,week 18 ,and every 9 weeks (or every 12 weeks after 54 weeks of treatment) for duration of study participation which is estimated to be 24 months.

Secondary Outcomes (1)

• Disease Control Rate（DCR）

  Assessed week 6,week 12,week 18 ,and every 9 weeks (or every 12 weeks after 54 weeks of treatment) for duration of study participation which is estimated to be 24 months.

Study Arms (2)

IBI310+Sintilimab

EXPERIMENTAL

IBI310+Sintilimab

Drug: IBI310; Drug: Sintilimab

Placebo+Sintilimab

ACTIVE COMPARATOR

Placebo+Sintilimab

Drug: Placebo; Drug: Sintilimab

Interventions

IBI310 DRUG

IBI310 3 mg/kg,Q3W, for a total of 4 cycles

IBI310+Sintilimab

Placebo DRUG

Placebo Q3W, for a total of 4 cycles

Placebo+Sintilimab

Sintilimab DRUG

Sintilimab 200mg,Q3W

Also known as: IBI308

IBI310+Sintilimab; Placebo+Sintilimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject must sign the written informed consent form, and can comply with the visits and related procedures specified in the protocol.
• Aged ≥18 years and ≤75 years.
• Diagnosed with cervical cancer by histology/cytology.
• Patients with relapsed or metastatic cervical cancer who have had progressed or relapsed after receiving at least first-line of platinum-based chemotherapy (if a patient has progressed or relapsed during or within 6 months after receiving platinum-based neoadjuvant or adjuvant chemotherapy, she will be deemed to have received first-line treatment).
• The subject's previous systemic treatment must have ended ≥4 weeks before the first study administration, and the treatment-related AEs have recovered to Common Terminology Criteria for Adverse Events (CTCAE) V5.0 grade ≤1 (except for alopecia and fatigue).

You may not qualify if:

• Diagnosis of other malignant tumors within 5 years before the first administration, excluding radically cured skin basal cell carcinoma, skin squamous cell carcinoma, radically resected carcinoma in situ and/or thyroid papillary carcinoma.
• Pleural effusion, ascites, and pericardial effusion with clinical symptoms or requiring drainage (patients with effusion that does not require drainage or patients with no significant increase in the effusion within 3 days after stopping drainage can be selected).
• Patients who are planning to undergo or have previously received organ or bone marrow transplantation.
• Patients with acute or chronic active hepatitis B or C infection, hepatitis B virus (HBV) DNA\> 200 IU/ml or 103 copies/ml; hepatitis C virus (HCV) antibody positive and HCV-RNA level higher than the lower limit of detection. Patients with acute or chronic active hepatitis B or C infection who have received nucleotide antiviral therapy and are below the above standards can be selected.
• Meningeal metastases or symptomatic central nervous system (CNS) metastases. Patients with asymptomatic brain metastases who do not need treatment with glucocorticoids, anticonvulsants or mannitol after radiotherapy can be enrolled.

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (2)

Innovent Biologics, Inc.

Suzhou, Jiangsu, 215123, China

Location

Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital）

Zhenjiang, China

Location

Related Publications (1)

• Li H, Xu Y, Jiao X, Xu Q, Peng Z, Tang Y, Zhang J, Huang B, Shen Y, Chang B, Xia B, Duan W, Wang D, Zhu L, An R, Zhang G, Tang Y, Huang J, Qiu H, Wang L, Huang Y, Li G, Qian J, Sun L, Zheng H, Lou G, Zhang Y, Chen Y, Lu L, Cheng Y, Liu J, Zhao W, Ji J, He A, Wang K, Yu G, Zhu H, Ma C, Yuan J, Wang X, Zhang H, Ma X, Cai C, Yin K, Xie H, Wang Y, Wang S, Li L, Zhou H, Wang J, Zhu J, Ma D, Gao Q. IBI310 plus sintilimab vs. placebo plus sintilimab in recurrent/metastatic cervical cancer: A double-blind, randomized controlled trial. Med. 2025 May 9;6(5):100573. doi: 10.1016/j.medj.2024.100573. Epub 2025 Jan 18.

  PMID: 39827881 DERIVED

MeSH Terms

Interventions

sintilimab

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: October 19, 2020
• Study Start: December 8, 2020
• Primary Completion: November 20, 2023
• Study Completion: November 20, 2023
• Last Updated: December 18, 2023

Record last verified: 2023-12

Locations

CN (2)