A Single-arm, Multicenter, Phase II Study to Evaluate Candonilimab（AK104） Combined With Radiotherapy For The Treatment of Locally Advanced Cervical Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- ORR assessed by Investigator
研究概览
简要总结
Candonilimab（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 candonilimab plus radiotherapy in participants with locally advanced cervical cancer who do not tolerate chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Able to understand and voluntarily sign written informed consent.
- •Women aged ≥18 years at the time of study entry.
- •Eastern Cancer Cooperative performance status (ECOG PS) score of 0 or
- •Life expectancy ≥12 weeks.
- •Participants' intolerance to chemotherapy regimens.
- •Histologically confirmed cervical cancer.
- •Histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix;
- •Not receiving systemic anti-tumour therapy (including but not limited to radiotherapy, targeted therapy and immunotherapy, etc; concurrent chemotherapy is not included. Note: Removal or biopsy of pelvic lymph nodes or para-aortic lymph nodes for the purpose of clinical staging is allowed).
- •Locally advanced cervical cancer（LACC）: The International Federation of Gynecology and Obstetrics (FIGO) 2018 Stage IB3/IIA2, IIB-IVA.
- •At least one measurable tumor lesion according to RECIST v1.1 criteria.
- •Available archived tumor tissue samples or recent biopsies.
- •Adequate organ function.
- •For fertile women with negative serum pregnancy and effective contraception within 7 days before administration (until 120 days after the last administration of the study drug and at least 180 days after radiotherapy)
排除标准
- •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 to randomization.
- •Subject who cannot receive brachytherapy.
- •Active or prior documented autoimmune disease that may relapse.
- •History of interstitial lung disease or noninfectious pneumonitis.
- •Subject with the clinically significant cardio-cerebrovascular disease.
- •History of severe hypersensitivity reactions to other mAbs.
- •Prior allogeneic stem cell transplantation or organ transplantation.
- •Subjects who require systemic treatment with glucocorticoid (>10 mg/day of prednisone or equivalent glucocorticoid) or other immunosuppressive agents within 14 days prior to randomization.
- •Receipt of live attenuated vaccines within 30 days prior to the first dose of the study drug.
- •Prior exposure to any experimental antitumor vaccines, or any agent targeting T-cell costimulation or immune checkpoint pathways (eg, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, anti-CD137 or anti-OX40 antibody, etc).
- •Any condition that, in the opinion of the Investigator, would interfere with the evaluation of the study drug or interpretation of subject safety or study results.
研究组 & 干预措施
treatment arm
Participants receive Cadonilimab at a dose of 10 mg/kg, Q3W (Day 1 of each 21 day treatment cycle) via IV infusion, until disease progression, intolerable toxicity, investigator determines that the participant cannot continue to benefit, withdraw informed consent, or Cadonilimab treatment over 2 years. During the q3w dosing period of Cadonilimab, participants receive radiotherapy including external beam radiotherapy (EBRT) and followed by brachytherapy.
干预措施: EBRT (Radiation)
treatment arm
Participants receive Cadonilimab at a dose of 10 mg/kg, Q3W (Day 1 of each 21 day treatment cycle) via IV infusion, until disease progression, intolerable toxicity, investigator determines that the participant cannot continue to benefit, withdraw informed consent, or Cadonilimab treatment over 2 years. During the q3w dosing period of Cadonilimab, participants receive radiotherapy including external beam radiotherapy (EBRT) and followed by brachytherapy.
干预措施: Cadonilimab（AK104） (Drug)
treatment arm
Participants receive Cadonilimab at a dose of 10 mg/kg, Q3W (Day 1 of each 21 day treatment cycle) via IV infusion, until disease progression, intolerable toxicity, investigator determines that the participant cannot continue to benefit, withdraw informed consent, or Cadonilimab treatment over 2 years. During the q3w dosing period of Cadonilimab, participants receive radiotherapy including external beam radiotherapy (EBRT) and followed by brachytherapy.
干预措施: BT (Radiation)
结局指标
主要结局
ORR assessed by Investigator
时间窗: Up to 2 years
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR per RECIST v1.1.
次要结局
- DCR(Up to 2 years)
- PFS(Up to approximately 30 months)
- Number of participants with adverse events (AEs)(Up to approximately 40 months)
- OS(Up to approximately 40 months)
- 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.(Baseline and up to approximately 40 months)
研究者
Qi Zhou
Professor
Chongqing University Cancer Hospital