Status:
ACTIVE_NOT_RECRUITING
A Study of AK104/Placebo Combined With Chemoradiotherapy For The Treatment of Locally Advanced Cervical Cancer
Lead Sponsor:
Akeso
Conditions:
Locally Advanced Cervical Carcinoma
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
June 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2029
Estimated Enrollment :
636 Patients enrolled
Trial Details
Trial ID
NCT05235516
Start Date
June 21 2022
End Date
May 1 2029
Last Update
August 13 2024
Active Locations (9)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100005
2
Guizhou Cancer Hospital
Guiyang, Guizhou, China, 550000
3
Hubei Cancer Hospital
Wuhan, Hubei, China, 430079
4
Xiangya Hospital Central South University
Changsha, Hunan, China, 410013