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
NCT ID: NCT04590599
Last Updated: 2023-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
205 participants
INTERVENTIONAL
2020-12-08
2023-11-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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IBI310+Sintilimab
IBI310+Sintilimab
IBI310
IBI310 3 mg/kg,Q3W, for a total of 4 cycles
Sintilimab
Sintilimab 200mg,Q3W
Placebo+Sintilimab
Placebo+Sintilimab
Placebo
Placebo Q3W, for a total of 4 cycles
Sintilimab
Sintilimab 200mg,Q3W
Interventions
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IBI310
IBI310 3 mg/kg,Q3W, for a total of 4 cycles
Placebo
Placebo Q3W, for a total of 4 cycles
Sintilimab
Sintilimab 200mg,Q3W
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Aged ≥18 years and ≤75 years.
3. Diagnosed with cervical cancer by histology/cytology.
4. 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).
5. 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).
Exclusion Criteria
2. 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).
3. Patients who are planning to undergo or have previously received organ or bone marrow transplantation.
4. 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.
5. 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.
18 Years
75 Years
FEMALE
No
Sponsors
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Innovent Biologics (Suzhou) Co. Ltd.
INDUSTRY
Responsible Party
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Locations
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Innovent Biologics, Inc.
Suzhou, Jiangsu, China
Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital）
Zhenjiang, , China
Countries
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References
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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.
Other Identifiers
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CIBI310E201
Identifier Type: -
Identifier Source: org_study_id