Cadonilimab（AK104）is a humanized IgG1 bispecific antibody that targets PD-1 and CTLA-4.
This is a single-arm, multicenter, open-label, phase II study, the purpose of this study is to evaluate the efficacy and safety of Cadonilimab plus radiotherapy in participants with locally advanced cervical cancer who do not tolerate chemotherapy.
Able to understand and voluntarily sign written informed consent.
Women aged ≥18 years at the time of study entry.
Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-2.
Life expectancy ≥12 weeks.
Other histological types of cervical cancer (eg, neuroendocrine carcinoma, small cell carcinoma, sarcoma, etc).
Evidence of distant metastases.
Have received total hysterectomy.
Subject with other active malignancies within 2 years prior enter the study.
Single group
Cadonilimab（AK104）
Drugq3w iv
EBRT
Radiation45-50.4Gy
BT
Radiation≥80Gy
ORR assessed by Investigator
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR per RECIST v1.1.
DCR
The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1.
PFS
Progression-free survival is defined as the time from the start of treatment with AK104 until the first documentation of disease progression or death due to any cause, whichever occurs first.
OS
OS is the time from randomization to death due to any cause
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status Score and Physical Function Score.
The EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Global scores are converted to a score of 0 to 100, with a higher score indicating improved health status. The change from baseline in EORTC QLQ-C30 score will be presented.
Click on the lead sponsor to view all of their trials.
Chongqing University Cancer Hospital
Lead sponsor
Liaoning Cancer Hospital & Institute
Collaborator
Henan Cancer Hospital
Collaborator
Fujian Cancer Hospital
Collaborator
