Actively Recruiting
A Phase II/III Study to Evaluate the Safety and Efficacy of BAT1308 Combined with Platinum-Based Chemotherapy evacizumab As First-Line Therapy for PD-L1-Positive Persistent, Recurrent or Metastatic Cervical Cancer
Led by Bio-Thera Solutions · Updated on 2025-02-10
526
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the safety and effectiveness of BAT1308 combined with platinum-based chemotherapy with or without Bevacizumab as a first treatment for women with PD-L1-positive persistent, recurrent, or metastatic cervical cancer. This trial includes a Phase II exploratory study to assess safety and preliminary effects and a Phase III randomized, double-blind study comparing BAT1308 plus chemotherapy with placebo plus chemotherapy. The study focuses on patients with a specific PD-L1 expression level and aims to improve progression-free and overall survival outcomes.
CONDITIONS
Brief Title
BAT1308 Combined with Platinum-Based Chemotherapy± Bevacizumab for PDL1-Positive (CPS ≥1) Cervical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 70 years who voluntarily sign the informed consent form
- Diagnosed with persistent, recurrent, or metastatic cervical cancer (FIGO Stage IVB) confirmed by pathology, including specific carcinoma types
- Positive for PD-L1 expression (CPS 1) in tumor specimens confirmed by central laboratory
- At least one measurable tumor lesion per RECIST v1.1 criteria
- Life expectancy of at least 12 weeks as evaluated by the investigator
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- Female patients of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study until 6 months after the last dose
- Postmenopausal women must have amenorrhea for at least 12 months
- Able to understand and willing to comply with trial requirements and follow-up procedures
You will not qualify if you...
- Other pathological types of cervical cancer such as small cell carcinoma or sarcoma
- Pregnant or lactating women
- Prior radiotherapy within 14 days before first dose except limited palliative radiotherapy
- Use of certain chemotherapeutic agents, traditional Chinese medicines, or vaccines within specified timeframes before first dose
- Prior treatments targeting tumor immunity such as immune checkpoint inhibitors
- Unresolved adverse events greater than Grade 1 from prior therapy, with some exceptions
- Active or uncontrolled brain metastases or leptomeningeal disease
- Major organ surgery or significant trauma within 4 weeks before first dose
- Serious infections within 4 weeks before first dose
- Active infections including HIV, hepatitis B or C, or syphilis
- Untreated or ongoing tuberculosis
- History of severe allergies to monoclonal antibodies or study drug components
- Contraindications or allergies to cisplatin, carboplatin, or paclitaxel
- Clinically significant hydronephrosis not relieved by intervention
- Uncontrollable pleural, pericardial effusions, or ascites needing repeated drainage
- Active or potentially recurrent autoimmune disease with some exceptions
- Recent systemic treatment with glucocorticoids or immunosuppressive agents
- History of pneumonitis requiring steroids or current interstitial lung disease
- Severe cardiovascular or cerebrovascular disorders including heart failure, arrhythmias, recent severe events, or uncontrolled hypertension
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 3-week cycles until disease progression or discontinuation
Participants receive BAT1308 combined with platinum-based chemotherapy ± Bevacizumab as first-line therapy for PD-L1-positive persistent, recurrent, or metastatic cervical cancer.
Visits every 3 weeks for treatment administration
Duration - Up to 2 years after first administration
Participants are monitored for progression-free survival, overall survival, vital signs, physical examinations, laboratory tests, and adverse events after treatment.
Regular assessments throughout study completion
Trial Site Locations
Total: 1 location
1
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, China
Actively Recruiting
Research Team
J
Juan Chen
Z
Zhaohe Wang, Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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