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.
Single group
Cadonilimab
DrugCadonilimab 10mg/kg,every 3 weeks,IV infusion
Nab paclitaxel
DrugNab paclitaxel ≤260mg/m2,every 3 weeks,IV infusion
Objective response rate (ORR)
To evaluate the clinical activity (as assessed by objective response rate \[ORR\]) of specific Cadonilimab and Nab-Paclitaxel combination.
Duration of response
To evaluate the clinical activity (as assessed by duration of response (DoR)) of Cadonilimab and Nab-Paclitaxel combinations. DOR: length of time tumor continues to respond to the treatment.
Disease control rate (DCR)
Defined as the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease.
Time to response (TTR)
Defined as the time from randomization to the date of the first confirmed documented response (CR or PR)
Progression Free survival
To evaluate the clinical activity (as assessed by progression-free survival \[PFS\]) of Cadonilimab and Nab-Paclitaxel combinations. PFS: Time from treatment initiation to the first documented disease progression per response evaluation criteria in solid tumors (RECIST) 1.1 as assessed by local site or death, whichever occurs first.
Exploratory endpoints
Evaluate the correlation between therapeutic effect and immune cells (T cells, B cells, myeloid and other subgroups), TCR, HPV, cytokines in tumor tissue and peripheral blood, and analyze the immune-resistant microenvironment characteristics, Dynamic changes of immune microenvironment before and after treatment with cadonilimab combined with nab-paclitaxel. Genomic profile predicts efficacy of cadonilimab combined with Nab-Paclitaxel.
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Women's Hospital School Of Medicine Zhejiang University
Lead sponsor
Akeso
Collaborator
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