RecruitingPhase 3NCT06459687

Phase III Study of Socazolimab as First-Line Treatment in Persistent, Recurrent, or Metastatic Cervical Cancer

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


Sponsor

Lee's Pharmaceutical Limited

Enrollment

440 participants

Start Date

Nov 28, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This Phase 3 trial studies whether adding socazolimab (an immunotherapy drug) to standard chemotherapy works better than chemotherapy alone as a first-line treatment for advanced or recurring cervical cancer. **You may be eligible if...** - You are female, age 18–75 - You have cervical cancer confirmed by biopsy (squamous cell, adenocarcinoma, or adenosquamous type) - Your cancer cannot be cured with surgery or radiation alone - You have at least one measurable tumor on CT or MRI scan - You are in reasonably good health (ECOG score 0–1) with a life expectancy of at least 3 months - You have not previously received immunotherapy or anti-angiogenic drugs (like bevacizumab) **You may NOT be eligible if...** - You have a rare type of cervical cancer (small cell, clear cell, sarcoma) - You have had another active cancer in the last 3 years - You have an active autoimmune disease - You have uncontrolled infections or serious organ problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSocazolimab+cisplatin/carboplatin+paclitaxel+Bevacizumab

6\~8 cycles of Socazolimab (5 mg/kg) + cisplatin (50 mg/m2) /carboplatin (AUC5) + paclitaxel (175 mg/m2) ± Bevacizumab (15 mg/kg), Q3w. Followed with Socazolimab (5 mg/kg), Q3w.

DRUGPlacebo+cisplatin/carboplatin+paclitaxel+Bevacizumab

6\~8 cycles of placebo (5 mg/kg) + cisplatin (50 mg/m2) /carboplatin (AUC5) + paclitaxel (175 mg/m2) ± Bevacizumab (15 mg/kg), Q3w. Followed with placebo (5 mg/kg), Q3w.


Locations(5)

Anhui Provincial Cancer Hospital

Hefei, Anhui, China

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT06459687


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