Tests zimberelimab with chemotherapy before surgery for locally advanced cervical cancer

Trial details

Who runs it

Tang-Du Hospital

Trial code

NCT06055738

Record updated

28 September 2023

Original description

This is a prospective, single arm, phase II clinical study to evaluate the efficacy and safety of Zimberelimab combined with albumin-bound paclitaxel and cisplatin as neoadjuvant therapy for locally advanced cervical cancer.Read full original descriptionShow less

An Exploratory Clinical Study of Zimberelimab Combined With Albumin-bound Paclitaxel and Cisplatin in Neoadjuvant Treatment of Locally Advanced Cervical Cancer

This is a prospective, single arm, phase II clinical study to evaluate the efficacy and safety of Zimberelimab combined with albumin-bound paclitaxel and cisplatin as neoadjuvant therapy for locally advanced cervical cancer.

Inclusion: Voluntary participation in clinical research; Age ≥18 years old, female; Squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix confirmed by histology/cytology; Previously untreated locally advancedcervical cancer (2018 FIGO stage IB3, IIA2) ; At least one measurable lesion was suitable for target lesion according to RECIST v1.1 ; Within 14 days before the first treatment, the major organ functions were basically normal; Eastern Cooperative Oncology Group (ECOG) performance status score 0-1; Subjects agree to provide sufficient tumor tissue samples for PD-L1 expression detection; If hepatitis B surface antigen (HBsAg) is positive and/or hepatitis B core antibody (HBcAb) is positive, hepatitis B virus DNA (HBV DNA) is detected, HBV DNA < 104 copies /ml or < 2000IU/mL can be enrolled. Or those who had received antiviral therapy for at least 4 weeks before the first dose of study drug and were willing to continue antiviral therapy during the study were eligible for enrollment. Those with HCV antibody positive should be excluded; Subjects of childbearing age and their sexual partners agreed to consent to contraceptive use after signing an informed consent form, during treatment and for at least 6 months after the last dose of the study intervention.

Exclusion: Previous history of allogeneic hematopoietic stem cell transplantation or organ transplantation (except corneal transplantation); Use of immunosuppressive drugs within 14 days prior to treatment, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroids (i.e., not more than 10 mg/ day of prednisolone or another corticosteroid at the physiological dose of the drug); Arterial or venous thromboembolic events within the previous 6 months, including myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack, pulmonary embolism, deep vein embolism or any other major thromboembolism, implantable venous access port or catheter-derived thrombosis, or superficial venous thrombosis. Except for patients with stable thrombus after conventional anticoagulant therapy, prophylactic use of low-dose low molecular weight heparin was allowed; Previous history of gastrointestinal perforation, gastrointestinal fistula, genital fistula (such as vesicovaginal fistula, urethrovaginal fistula, vesicovaginal fistula, etc.); Patients were allowed if the perforation or fistula had been treated with diversion surgery, resection, or repair, and the disease was recovered or relieved as judged by the investigator; Active pulmonary tuberculosis, receiving anti-tuberculosis treatment; Severe infections that are active or poorly controlled clinically. Severe infection within 3 weeks before treatment, including but not limited to patients hospitalized for complications of infection, bacteremia, or severe pneumonia; Have received live vaccine within 4 weeks of the first use of the experimental drug, or plan to receive live vaccine during the study; Patients with active autoimmune disease or a history of autoimmune disease; Symptomatic congestive heart failure (New York Heart Association class II-IV) Arrhythmias with poorly controlled symptoms; Interstitial lung disease; Central nervous system metastasis, leptomeningeal metastasis, spinal cord compression, or leptomeningeal disease; Human immunodeficiency virus (HIV) infection, known syphilis infection; Known or suspected allergy to the trial drug or any drug related to the trial; There were other conditions deemed by the investigator to be inappropriate for enrollment; Previous treatment with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody, or anti-lymphocyte antigen 4 (CTLA-4) antibody; Pregnant or lactating women.

ClinicalTrials.gov NCT06055738