Trial Title:
BAT1308 Combined With Platinum-Based Chemotherapy± Bevacizumab For PDL1-Positive (CPS ≥1) Cervical Cancer
NCT ID:
NCT06123884
Condition:
Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Paclitaxel
Bevacizumab
Carboplatin
Antibodies
Antibodies, Monoclonal
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Care Provider, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
Recombinant humanized anti-PD-1 monoclonal antibody injection
Description:
Strength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3
weeks (21 days) (Q3W).
Arm group label:
BAT1308
Arm group label:
BAT1308 monoclonal antibody
Other name:
BAT1308 injection
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
the usage and dosage should be determined by the investigator
Arm group label:
BAT1308
Arm group label:
BAT1308 monoclonal antibody
Other name:
Shunbo
Intervention type:
Drug
Intervention name:
Bevacizumab Injection
Description:
Strength 100 mg/4 mL, recommended dose 15 mg/kg body weight, administered every 3 weeks
(15 mg/kg, Q3W)
Arm group label:
BAT1308
Arm group label:
BAT1308 monoclonal antibody
Other name:
Pobevcy
Intervention type:
Drug
Intervention name:
carboplatin
Description:
the usage and dosage should be determined by the investigator
Arm group label:
BAT1308
Arm group label:
BAT1308 monoclonal antibody
Other name:
Bobei
Intervention type:
Drug
Intervention name:
Paclitaxel for Injection
Description:
the usage and dosage should be determined by the investigator
Arm group label:
BAT1308
Arm group label:
BAT1308 monoclonal antibody
Other name:
Tesu
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
Detailed description:
The single-arm Phase II exploratory study designed to evaluate the safety and efficacy of
the study drug will include 20-50 subjects to explore the safety and preliminary efficacy
of BAT1308 combined with platinum-based chemotherapy ± Bevacizumab. Dynamic analysis will
be conducted after the inclusion of 20 subject. If the safety of this combination regimen
is manageable and the efficacy meets expectations, the enrollment in the Phase II study
will be stopped and the Phase III study will be entered. The Phase III study is a
randomized, double-blind, multicenter clinical study of BAT1308 combined with
platinum-based chemotherapy ± Bevacizumab versus placebo plus platinum-based chemotherapy
± Bevacizumab as first-line therapy for PD-L1-positive (CPS ≥ 1) persistent, recurrent or
metastatic cervical cancer. PFS and OS will be used as the combined endpoints, and a
superiority design will be adopted with a total sample size of 476 subjects. Stratified
block randomization will be performed based on the following random factors: patients
will be stratified based on the presence of metastatic diseases at the time of diagnosis
(Yes vs. No), PD-L1 CPS (1-10 vs. ≥ 10) and planned use of Bevacizumab (Yes vs. No).
Criteria for eligibility:
Criteria:
inclusion criteria：
1. Female patients, aged ≥18 years to ≤70 years, who voluntarily sign the informed
consent form;
2. With persistent, recurrent or metastatic (the Federation International of Gynecology
and Obstetrics [FIGO] Stage IVB) cervical cancer confirmed histologically
(pathological reports required), including pathological types of squamous cell
carcinoma, adenocarcinoma, adenosquamous cell carcinoma and clear-cell renal-cell
carcinoma, not amenable to radical surgery and/or radical radiotherapy or
radiochemotherapy, with no prior systemic anti-tumor therapy for persistent,
recurrent or metastatic cervical cancer;
3. Subjects should be positive for PD-L1 expression (CPS ≥ 1) in tumor specimens by the
central laboratory. Subjects should provide sufficient formalin-fixed
paraffin-embedded (FFPE) specimens or sections (6 sections recommended, not less
than 3 sections), and be willing to undergo a tumor tissue biopsy for PD-L1 testing
when necessary. The archival tissues must be representative tumor specimens
collected within three years or unstained continuous sections of FFPE tumor tissues
freshly resected within six months, and relevant pathological reports of the
aforementioned specimens must also be provided. Both surgical resection and biopsy
are acceptable methods for acquiring fresh tissue specimens; fine-needle aspiration
and liquid-based cytology (TCT) samples (i.e., samples lacking complete tissue
structures and providing only cell suspension and/or cell smears) are not
acceptable; decalcified bone metastasis tumor tissue specimens are not acceptable;
4. 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 of the lesion occurs or the tumor
activity of the lesion is confirmed by biopsy and the lesion is measurable
5. Life expectancy ≥12 weeks as evaluated by the investigator;
6. Eastern Cooperative Oncology Group (ECOG) Performance Status score 0 or 1;
7. 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 the study until 6 months
after the last dose of the study drug. Postmenopausal women must have amenorrhea for
at least 12 months before they are considered as women of non-childbearing
potential.
9. Able to understand trial requirements, willing and able to comply with the trial and
follow-up procedures.
exclusion criteria：
1. Subjects with other pathological types of cervical cancer, such as small cell
carcinoma, sarcoma, etc.;
2. Pregnant or lactating women;
3. 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 area < 5% of bone marrow area);
prior chemotherapeutic agents for increasing the sensitization to radiotherapy
within 14 days before the first dose; prior use of traditional Chinese patent
medicines or treatment with anti-tumor related functions as specified in the
NMPA-approved package inserts within 14 days before the first dose, or Chinese
herbal medicines for anti-tumor purposes clearly documented in the medical record ;
4. 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;
5. 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 co-stimulatory
molecules (e.g., antibodies targeting ICOS, CD40, CD137, GITR, OX40, etc.);
6. 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 will remain stable for a long time
as judged by the investigator based on actual clinical situations, except for Grade
2 peripheral neurotoxicity, and hypothyroidism stabilized by hormone replacement
therapy); patients who previously experienced ≥ Grade 3 irAEs or discontinued
immunotherapy due to irAEs of any grade;
7. 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 examinations performed at least 28 days
before the first dose of the study drug showed stable disease and no treatment
(e.g., radiotherapy, surgery, or corticosteroid treatment) is required to control
the symptoms of brain metastases within 28 days before the first dose of the study
drug;
8. 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 period;
9. Subjects 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; subjects with active infection before the first dose are
excluded;
10. 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 deoxyribonucleic acid (HBV-DNA) test
> 500 IU/ml or 103 copies/ml or above the upper limit of normal at the testing
institution]; hepatitis C virus infection [anti-HCV antibodies and hepatitis C virus
ribonucleic acid (HCV-RNA) test positive]; Treponema pallidum antibody positive and
rapid plasma reagin (RPR) positive;
11. Subjects 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 investigator may be included;
12. Subjects 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;
13. Known to have any contraindication to cisplatin/carboplatin or paclitaxel, or
allergy to any of their components;
14. Clinically significant hydronephrosis that cannot be relieved by nephrostomy or
ureteral stent insertion as judged by the investigator;
15. Subjects with uncontrollable pleural effusion, pericardial effusion, or ascites
requiring repeated drainage;
16. 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);
17. 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 situations: ① topical,
ocular, intra-articular, nasal, and inhaled glucocorticoid therapy; ② short-term use
of glucocorticoid for prophylaxis (e.g., prevention of contrast allergy);
18. Subjects with a history of noninfectious pneumonitis requiring glucocorticoid
therapy within 1 year before the first dose or with current interstitial lung
disease;
19. 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) <50%; ② Severe cardiac rhythm or
conduction abnormalities, such as ventricular arrhythmia requiring clinical
intervention, II-III degree atrioventricular block, etc.; ③ Acute coronary syndrome,
congestive cardiac failure, aortic dissection, stroke, or other Grade 3 or above
cardiovascular and cerebrovascular events within 6 months before the first dose; ④
Clinically uncontrollable hypertension (defined in this protocol as systolic blood
pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg despite the use of
antihypertensive therapy);
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Address:
City:
Wuhan
Country:
China
Contact:
Last name:
Qinglei Gao, Ph.D
Start date:
November 2023
Completion date:
August 2024
Lead sponsor:
Agency:
Bio-Thera Solutions
Agency class:
Industry
Source:
Bio-Thera Solutions
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06123884
