This is a phase II trial of combination therapy of cadonilimab(Bispecific Anti-PD-1/CTLA-4 Antibody) plus nab-Paclitaxel in patients with recurrent or metastatic cervical cancer that had failed PD-1/PD-L1 blockade therapy. As a bispecific antibody against PD-1 and CTLA-4, cardonirimab can not only induce the production of a large number of T cells in the early stage of immune response by antagonizing CTLA-4, but also block PD-1 and PD-L1/L2 combination. Thereby restoring the killing function of T cells to tumor cells and reducing the exhaustion of T cells.The hypothesis is the combination of cadonilimab and nab-Paclitaxel will overcome PD-1/PD-L1 blockade-resistance to enhance the response of patients with persistant, recurrent or metastatic cervical cancer.
Subjects are autonomous and fully autonomous, understand and voluntarily sign a written informed consent within 30 days before enrollment.
Age ≥ 18 and ≤ 75 years old on the date of signing the informed consent form, female.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Expected survival period ≥ 3 months.
Suffering from other active malignant tumors within 3 years before randomization, except locally curable tumor types and those who have been cured, such as Squamous cell carcinoma of the skin, basal cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the breast.
Severe immunotherapy-related toxicity occurred during the previous anti-PD-1/PD-L1 monoclonal antibody treatment, including but not limited to: grade 3/4 pneumonia, proteinuria, uveitis or episcleritis, myasthenia gravis, Pancreatitis, hepatitis, bullous skin disease (including SJS, TEN); grade 2-4 encephalitis, myocarditis; any grade of Guillain-Barré syndrome, transverse myelitis; severe inflammation that significantly affects the quality of life of the patient sex joints.
Received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, or other unmarketed clinical research drugs and other anti-tumor treatments within 4 weeks before the first use of the study drug.
Received nab-paclitaxel drug therapy within 6 months before the first use of the study drug. Known contraindications to nab-paclitaxel or hypersensitivity to any of its components.
Women's Hospital School Of Medicine Zhejiang University
Lead sponsor
Akeso
Collaborator