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New treatment option for Cervical Cancer
Official title Phase III Study of Socazolimab as First-Line Treatment in Persistent, Recurrent, or Metastatic Cervical Cancer
ClinicalTrials.gov ID: NCT06459687
What this study is testing
What is Socazolimab+cisplatin/carboplatin+paclitaxel+Bevacizumab?
Socazolimab+cisplatin/carboplatin+paclitaxel+Bevacizumab is an investigational medicine, being studied as a potential treatment for cervical cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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.
See the full eligibility 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 people 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...
- 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 people from the signing of informed consent until 180 days after the last administration of the study drug.
- 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...
- 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\. people 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...
- 22\. people 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 people with...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Hangzhou, Zhejiang, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Beijing, Beijing Municipality, China; Wuhan, Hubei, China; Changsha, Hunan, China; Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.