RecruitingPhase 2Phase 3NCT06123884

BAT1308 Combined with Platinum-Based Chemotherapy± Bevacizumab for PDL1-Positive (CPS ≥1) Cervical Cancer

A Phase II/III Study to Evaluate the Safety and Efficacy of BAT1308 Combined with Platinum-Based Chemotherapy ± Bevacizumab As First-Line Therapy for PD-L1-Positive (CPS ≥ 1) Persistent, Recurrent or Metastatic Cervical Cancer


Sponsor

Bio-Thera Solutions

Enrollment

526 participants

Start Date

Dec 13, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Phase II study: a study to explore the safety and preliminary efficacy of BAT1308 combined with platinum-based chemotherapy ± Bevacizumab Phase III study: a confirmatory study to evaluate the safety and efficacy of BAT1308 combined with platinum-based chemotherapy ± Bevacizumab as first-line therapy for PD-L1-positive (CPS ≥ 1) persistent, recurrent or metastatic cervical cancer


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding BAT1308 — an immunotherapy that blocks the PD-1 checkpoint — to standard platinum-based chemotherapy (with or without bevacizumab, a drug that slows tumor blood vessel growth) can improve outcomes for women with advanced, persistent, or recurrent cervical cancer whose tumors express the PD-L1 protein. **You may be eligible if...** - You are a woman aged 18–70 with confirmed cervical cancer (squamous cell, adenocarcinoma, adenosquamous, or clear-cell type) - Your cancer is persistent, recurrent, or has spread to distant organs (stage IVB) and cannot be cured with surgery or radiation - You have not received prior systemic treatment for advanced or recurrent cervical cancer - Your tumor tests positive for PD-L1 (CPS ≥1) - You are in good overall health (ECOG 0 or 1) with a life expectancy of at least 12 weeks **You may NOT be eligible if...** - You have received prior chemotherapy or immunotherapy for recurrent or metastatic cervical cancer - You are pregnant or have significant organ dysfunction - You have uncontrolled infection, active autoimmune disease, or significant cardiovascular disease 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

DRUGRecombinant humanized anti-PD-1 monoclonal antibody injection

Strength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3 weeks (21 days) (Q3W).

DRUGCisplatin

the usage and dosage should be determined by the investigator

DRUGBevacizumab Injection

Strength 100 mg/4 mL, recommended dose 15 mg/kg body weight, administered every 3 weeks (15 mg/kg, Q3W)

DRUGcarboplatin

the usage and dosage should be determined by the investigator

DRUGPaclitaxel for Injection

the usage and dosage should be determined by the investigator


Locations(1)

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

Wuhan, Hubei, China

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NCT06123884


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