A Study of AK104/Placebo Combined With Chemoradiotherapy For The Treatment of Locally Advanced Cervical Cancer
- Conditions
- Locally Advanced Cervical Carcinoma
- Interventions
- Registration Number
- NCT05235516
- Lead Sponsor
- Akeso
- Brief Summary
This study is to evaluate the efficacy and safety of AK104 plus concurrent chemoradiotherapy compared to placebo plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 636
- signs the written informed consent form
- ECOG 0-1
- Life expectancy ≥ 3 months.
- The histological types include squamous cell carcinoma,adenocarcinoma, or adenosquamous cell carcinoma;
- Locally advanced cervical cancer (LACC): The International Federation of Gynecology and Obstetrics (FIGO) 2018 Stage 3A-4A
- At least one measurable tumor lesion per RECIST v1.1
- Adequate organ function as assessed in the laboratory tests
- Subjects with other histopathological types of cervical cancer, such as small cell carcinoma, sarcoma, etc.
- FIGO 2018 IVB
- Subjects who had previously undergone total hysterectomy
- Subjects who cannot receive brachytherapy
- Subjects with other active malignancies within 2 years prior to randomization
- Clinically significant hydronephrosis that cannot be relieved by nephrostomy or ureteral stenting as judged by the Investigator
- Any prior treatments targeting the mechanism of tumor immunity, such as immune checkpoint inhibitors (e.g., anti-PD-1 antibody, anti-PDL1 antibody, anti-CTLA-4 antibody, etc.), or therapy against immune costimulatory factors (e.g., antibodies directed against ICOS, CD40,CD137, GITR, OX40 targets, etc).
- 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;
- Major surgical treatment, open biopsy or significant trauma within 4 weeks prior to randomization; or elective major surgical treatment required during the study
- Use of live vaccines within 4 weeks prior to randomization
- Active or potentially recurrent autoimmune disease
- Known primary or secondary immunodeficiencies, including testing positive for human immunodeficiency virus (HIV) antibodies
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
- Known history of interstitial lung disease or non-infectious pneumonitis
- Pregnant or lactating women.
- Any condition that, in the opinion of the Investigator, may result in a risk when receiving the study drug.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description treatment arm AK104 - treatment arm EBRT - treatment arm BT - placebo arm EBRT - placebo arm BT - placebo arm cisplatin - placebo arm Placebo - treatment arm cisplatin -
- Primary Outcome Measures
Name Time Method Progression-Free Survival(PFS) by investigator(INV) 54 months PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1 and/or biopsy
- Secondary Outcome Measures
Name Time Method PFS rate at month 36 36 months PFS rate at month 36
Overall Survival(OS) 5 years OS is defined as the time from randomization to death due to any cause.
Trial Locations
- Locations (9)
Hubei Cancer Hospital
🇨🇳Wuhan, Hubei, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
Guizhou Cancer Hospital
🇨🇳Guiyang, Guizhou, China
West China Second University Hospital
🇨🇳Chengdu, Sichuan, China
Women's Hospital School Of Medicine Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
Xiangya Hospital Central South University
🇨🇳Changsha, Hunan, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
Hunan cancer hospital
🇨🇳Changsha, Hunan, China