Using Socazolimab with chemotherapy for advanced cervical cancer treatment
Official title: Efficacy and Safety of Socazolimab Combined With Chemotherapy With or Without Bevacizumab as First-Line Treatment in Persistent, Recurrent, or Metastatic Cervical Cancer: A Randomized, Double-blind, Placebo-controlled Phase III Study
Run by Lee's Pharmaceutical Limited · NCT06459687 · Data updated 2026-11-12
This study is testing if adding Socazolimab to chemotherapy helps people with advanced cervical cancer feel better and live longer compared to just chemotherapy alone.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | Women only |
| Enrollment | 440 (estimated) |
| Sponsor | Lee's Pharmaceutical Limited Industry-sponsored |
| Drugs / interventions | bevacizumab, prednisone, Socazolimab, chemotherapy |
| Locations | 5 sites (Hefei, Anhui and 4 other locations) |
| Status | Recruiting |
| Started | November 28, 2024 |
| Main results expected | September 1, 2027 |
| Study ends | September 1, 2028 |
| Registry record updated | May 14, 2025 |
| Trial ID | NCT06459687 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are females aged 18 to 75 with histologically confirmed cervical cancer that is not amenable to surgery or radiotherapy.
✕Probably not a fit
Patients with cervical cancer that can be cured by surgery or radiotherapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the efficacy and safety of Socazolimab when combined with chemotherapy, with or without bevacizumab, as a first-line treatment for patients with persistent, recurrent, or metastatic cervical cancer. Participants will receive either the Socazolimab treatment or a placebo alongside standard chemotherapy for 6 to 8 cycles, followed by maintenance therapy. The primary objective is to determine if the combination of Socazolimab and chemotherapy provides better outcomes compared to placebo in this patient population.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients with advanced cervical cancer.
How similar studies have gone: Other studies have shown promise with similar approaches, but this specific combination is being evaluated for the first time in this context.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. Able to understand and voluntarily signed written informed consent. Informed consent must be signed prior to specified study procedure. * 2\. Age ≥ 18 years and ≤75 years on the date of signing the informed consent, female. * 3\. ECOG Physical fitness score was 0 or 1. * 4\. Life expectancy ≥ 3 months. * 5\. Histologically confirmed cervical cancer that cannot be cured by surgery or radiotherapy/concurrent chemoradiotherapy. * 6\. Have at least one measurable tumor lesion examined by CT or MRI according to RECIST v1.1 criteria; * 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. * 8\. Laboratory examination results during the screening period indicate that the subject has good organ function. * 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: * 1\. Other histopathological types of cervical cancer, such as small cell carcinoma, clear cell carcinoma, sarcoma, etc. * 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. * 3\. Active or potentially recurring autoimmune disease. * 4\. Patients with other active malignant tumors within 3 years prior to randomization. * 5\. Participants who had participated in other clinical studies and used other clinical trial drugs within 4 weeks before randomization. * 6\. Major surgery, open biopsy or significant trauma within 4 weeks before randomization; Or an expected major surgical treatment during the study. * 7\. Anti-tumor therapy within 4 weeks before randomization. * 8\. Severe infection occurring within 4 weeks prior to randomization. * 9\. Vaccination within 4 weeks prior to randomization. * 10\. Received immune-modulating drugs (such as thymosin, interferon, interleukin-2) within 2 weeks before randomization. * 11\. Use of systemic antibacterial, antiviral, or antifungal drugs within 2 weeks prior to randomization. * 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. * 13\. Clinically significant hydronephrosis that cannot be relieved by nephrostomy or ureteral stenting as determined by the investigator. * 14\. Central nervous system metastatic or cancerous meningitis. * 15\. Uncontrolled pleural, pericardial, or peritoneal effusions requiring repeated drainage (more frequently than monthly). * 16\. Known primary or secondary immunodeficiency, including a positive test for human immunodeficiency virus (HIV) antibodies. * 17\. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. * 18\. Known active tuberculosis; Known active treponema pallidum infection. * 19\. known history of severe hypersensitivity to other monoclonal antibodies. * 20\. Known contraindications to cisplatin/carboplatin, paclitaxel, or allergies to any components. * 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. * 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. * 23\. Active or documented inflammatory bowel disease. * 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%. * 25\. NCI CTCAE v5.0 ≥ 2 grade peripheral neuropathy. * 26\. Not recovered from toxicity of previous antitumor therapy. * 27\. Pregnant or lactating women. * 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. * 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.
Where it's running
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Anhui Provincial Cancer Hospital
Hefei, Anhui, China Recruiting -
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China Recruiting -
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China Recruiting -
Hunan Cancer Hospital
Changsha, Hunan, China Recruiting -
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China Recruiting
Similar studies
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Sacituzumab tirumotecan plus pembrolizumab as first-line maintenance for metastatic cervical cancer
This trial tests whether adding the antibody-drug conjugate sacituzumab tirumotecan to pembrolizumab (with or without bevacizumab) as maintenance treatment can help people with metastatic cervical cancer live longer or keep the cancer from growing.
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BL-B01D1 plus pembrolizumab, with or without bevacizumab, for recurrent or metastatic cervical and endometrial cancer
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.