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

NCT06459687 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2025-05-14

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Socazolimab+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.

DRUG

Placebo+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.

Sponsors & Collaborators

  • Lee's Pharmaceutical Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-28
Primary Completion
2027-09-01
Completion
2028-09-01

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06459687 on ClinicalTrials.gov