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New treatment option for Cervical Cancer
Official title BAT1308 Combined with Platinum-Based Chemotherapy± Bevacizumab for PDL1-Positive (CPS ≥1) Cervical Cancer
ClinicalTrials.gov ID: NCT06123884
What this study is testing
What is Recombinant humanized anti-PD-1 monoclonal antibody injection?
Recombinant humanized anti-PD-1 monoclonal antibody injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cervical cancer.
Also referred to as BAT1308 injection.
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
- 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
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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 70, women only
You may be able to join if
- Female patients, aged ≥18 years to ≤70 years, who voluntarily sign the informed consent form;
- With persistent, recurrent or metastatic (the Federation International of Gynecology and Obstetrics [FIGO] Stage IVB) cervical cancer confirmed...
- people should be positive for PD-L1 expression (CPS ≥ 1) in tumor specimens by the central laboratory. people should provide sufficient...
- At least one measurable tumor lesion per RECIST v1.1; lesions at sites previously treated with radiotherapy or other loco-regional therapies can only...
- Life expectancy ≥12 weeks as evaluated by the investigator;
You likely can't join if
- people with other pathological types of cervical cancer, such as small cell carcinoma, sarcoma, etc.;
- Pregnant or lactating women;
- Prior radiotherapy within 14 days before the first dose. Except for palliative area radiotherapy for bone metastases for which pain cannot be...
- Patients who received live/attenuated vaccines and mRNA vaccines within 4 weeks prior to screening or scheduled to receive those vaccines during the...
- Any prior treatments targeting the mechanism of tumor immunity, such as immune checkpoint inhibitors (e.g., anti-PD-1 antibodies, anti-PD-L1...
- AEs caused by prior anti-tumor therapy that are still \> Grade 1 (as per CTCAE v5.0) before the first dose of the study drug (except for AEs, such as...
See the full eligibility criteria
Who can join
- Female patients, aged ≥18 years to ≤70 years, who voluntarily sign the informed consent form;
- With persistent, recurrent or metastatic (the Federation International of Gynecology and Obstetrics [FIGO] Stage IVB) cervical cancer confirmed histologically (pathological reports required), including pathological...
- people should be positive for PD-L1 expression (CPS ≥ 1) in tumor specimens by the central laboratory. people should provide sufficient formalin-fixed paraffin-embedded (FFPE) specimens or sections (6 sections...
- At least one measurable tumor lesion per RECIST v1.1; lesions at sites previously treated with radiotherapy or other loco-regional therapies can only be considered as non-target lesions, unless unequivocal progression...
- Life expectancy ≥12 weeks as evaluated by the investigator;
- Eastern Cooperative Oncology Group (ECOG) Performance Status score 0 or 1;
- Female patients of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose and are willing to take effective birth control/contraceptive methods to prevent pregnancy during...
What rules you out
- people with other pathological types of cervical cancer, such as small cell carcinoma, sarcoma, etc.;
- Pregnant or lactating women;
- Prior radiotherapy within 14 days before the first dose. Except for palliative area radiotherapy for bone metastases for which pain cannot be effectively controlled by systemic therapy or local pain relief (radiotherapy...
- Patients who received live/attenuated vaccines and mRNA vaccines within 4 weeks prior to screening or scheduled to receive those vaccines during the study period;
- Any prior treatments targeting the mechanism of tumor immunity, such as immune checkpoint inhibitors (e.g., anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.) or therapies that target immune...
- AEs caused by prior anti-tumor therapy that are still \> Grade 1 (as per CTCAE v5.0) before the first dose of the study drug (except for AEs, such as alopecia, fatigue, etc., that cannot be recovered to ≤ Grade 1 and...
- Active leptomeningeal disease or poorly controlled brain metastases. Patients with suspected or confirmed brain metastases are allowed to be enrolled if they have no obvious symptoms and the results of imaging...
- Patients who underwent major organ surgery (excluding aspiration biopsy) or experienced significant trauma within 4 weeks before the first dose of the study drug, or those who require elective surgery during the trial...
- people with serious infections within 4 weeks before the first dose, including but not limited to the infection-related complications, bacteremia and severe pneumonia requiring hospitalization; people with active...
- Patients with the following infectious diseases: human immunodeficiency virus (HIV) infection; active hepatitis B virus infection [hepatitis B surface antigen (HBsAg) positive, and the result for hepatitis B virus...
- people with tuberculosis untreated or under treatment, including but not limited to pulmonary tuberculosis; patients whose tuberculosis was cured after standardized anti-tuberculosis treatment as confirmed by the...
- people with known history of severe allergy or prior ≥ Grade 3 allergic reactions to macromolecular protein preparations/monoclonal antibodies, and any component of the investigational drug;
- Known to have any contraindication to cisplatin/carboplatin or paclitaxel, or allergy to any of their components;
- Clinically significant hydronephrosis that cannot be relieved by nephrostomy or ureteral stent insertion as judged by the investigator;
- people with uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
- Patients with active or potentially recurrent autoimmune disease (excluding patients with vitiligo, autoimmune thyroid disorder that can be treated with hormone replacement therapy, or type 1 diabetes mellitus);
- Patients who required systemic treatment with glucocorticoid (\>10 mg/day of prednisone or equivalent) or other immunosuppressive agents within 14 days before the first dose of the study drug, except for the following...
- people with a history of noninfectious pneumonitis requiring glucocorticoid therapy within 1 year before the first dose or with current interstitial lung disease;
- History of severe cardiovascular and cerebrovascular disorders, including but not limited to: ① New York Heart Association (NYHA) Class II or above cardiac failure or left ventricular ejection fraction (LVEF) \ 160 mmHg...
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, 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.