Overview
The goal of this clinical trial is to evaluate the efficacy and safety of Socazolimab combined with chemotherapy with or without bevacizumab as first-Line treatment in persistent, recurrent, or metastatic cervical cancer. The main question it aims to answer is:
Does Socazolimab combined with chemotherapy with or without bevacizumab better benefit patients with persistent, recurrent, or metastatic cervical cancer as first-line treatment compared with placebo combined with chemotherapy with or without bevacizumab.
Participants will be treated with Socazolimab/placebo + chemotherapy ± bevacizumab) for 6~8 cycles (Q3w), following maintenance treatment of Socazolimab/placebo (Q3w).
Eligibility
Inclusion Criteria:
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- Able to understand and voluntarily signed written informed consent. Informed consent must be signed prior to specified study procedure.
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2. Age ≥ 18 years and ≤75 years on the date of signing the informed consent,
female.
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3. ECOG Physical fitness score was 0 or 1.
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4. Life expectancy ≥ 3 months.
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5. Histologically confirmed cervical cancer that cannot be cured by surgery or
radiotherapy/concurrent chemoradiotherapy.
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6. Have at least one measurable tumor lesion examined by CT or MRI according to
RECIST v1.1 criteria;
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7. All subjects must provide archived or freshly obtained tumor tissue samples
(formalin-fixed paraffin-embedded [FFPE] tissue wax blocks or at least 5
unstained tumor tissue section samples, preferably newly obtained tumor tissue
samples) within the previous 5 years of randomization.
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8. Laboratory examination results during the screening period indicate that the
subject has good organ function.
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9. Effective contraception should be used by fertile female subjects from the
signing of informed consent until 180 days after the last administration of the
study drug.
Exclusion Criteria:
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- Other histopathological types of cervical cancer, such as small cell carcinoma, clear cell carcinoma, sarcoma, etc.
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2. Prior anti-angiogenic therapy (e.g., bevacizumab), immune checkpoint inhibitors
(e.g., anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.), or
targeting immune costimulators (e.g. antibodies against ICOS, CD40, CD137,
GITR, OX40 targets, etc.) and any treatment targeting the immune mechanism of
tumor.
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3. Active or potentially recurring autoimmune disease.
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4. Patients with other active malignant tumors within 3 years prior to
randomization.
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5. Participants who had participated in other clinical studies and used other
clinical trial drugs within 4 weeks before randomization.
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6. Major surgery, open biopsy or significant trauma within 4 weeks before
randomization; Or an expected major surgical treatment during the study.
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7. Anti-tumor therapy within 4 weeks before randomization.
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8. Severe infection occurring within 4 weeks prior to randomization.
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9. Vaccination within 4 weeks prior to randomization.
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10. Received immune-modulating drugs (such as thymosin, interferon, interleukin-2)
within 2 weeks before randomization.
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11. Use of systemic antibacterial, antiviral, or antifungal drugs within 2 weeks
prior to randomization.
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12. Subjects requiring systemic treatment with corticosteroids (> 10 mg/ day of
prednisone or equivalent doses of corticosteroids) or other immunosuppressive
drugs within 2 weeks prior to randomization.
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13. Clinically significant hydronephrosis that cannot be relieved by nephrostomy or
ureteral stenting as determined by the investigator.
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14. Central nervous system metastatic or cancerous meningitis.
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15. Uncontrolled pleural, pericardial, or peritoneal effusions requiring repeated
drainage (more frequently than monthly).
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16. Known primary or secondary immunodeficiency, including a positive test for
human immunodeficiency virus (HIV) antibodies.
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17. Known history of allogeneic organ transplantation and allogeneic hematopoietic
stem cell transplantation.
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18. Known active tuberculosis; Known active treponema pallidum infection.
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19. known history of severe hypersensitivity to other monoclonal antibodies.
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20. Known contraindications to cisplatin/carboplatin, paclitaxel, or allergies to
any components.
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21. Previous and/or current presence of interstitial lung disease, pneumoconiosis,
drug-related pneumonia, severe impairment of pulmonary function, etc., that may
interfere with the detection and management of suspected drug-related pulmonary
toxicity.
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22. Subjects with active viral hepatitis B, inactive or asymptomatic carriers of
hepatitis B virus (HBV) (positive for hepatitis B surface antigen [HBsAg]) with
HBV DNA > 500 IU/mL or > 2500 copies/mL), and subjects with active viral
hepatitis C.
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23. Active or documented inflammatory bowel disease.
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24. Any of the following cardiovascular diseases: a) myocardial infarction,
unstable angina pectoris, pulmonary embolism, aortic dissection, deep vein
thrombosis, and any arterial thromboembolism event occurred within 6 months
before randomization; b) New York Heart Association (NYHA) heart function grade
≥ II heart failure; c) There is a serious arrhythmia that requires drug
intervention; Patients with asymptomatic atrial fibrillation with stable
ventricular rate were admitted; d)Left ventricular ejection fraction (LVEF) <
50%.
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25. NCI CTCAE v5.0 ≥ 2 grade peripheral neuropathy.
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26. Not recovered from toxicity of previous antitumor therapy.
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27. Pregnant or lactating women.
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28. Any condition (such as another serious illness or psychiatric disorder) that
the investigator believes may result in a risk for acceptance of the study drug
or that would interfere with the evaluation of the study drug or with the
safety of the subjects or the interpretation of the study results.
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29. Known contraindications to bevacizumab or allergies to any of its components,
or the presence of any medical conditions that could affect the safety of
bevacizumab administration.