Clinical trial NCT05235516: A Study of AK104/Placebo Combined With Chemoradiotherapy For The Treatment of Locally Advanced Cervical Cancer
Official title: A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate AK104 Combined With Chemoradiotherapy For The Treatment of Locally Advanced Cervical Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Locally Advanced Cervical Carcinoma
Lead sponsor: Akeso
Sponsor class: INDUSTRY
First posted: 2022-02-11
Enrollment: 636
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Criteria:

1. signs the written informed consent form
2. ECOG 0-1
3. Life expectancy ≥ 3 months.
4. The histological types include squamous cell carcinoma,adenocarcinoma, or adenosquamous cell carcinoma;
5. Locally advanced cervical cancer (LACC): The International Federation of Gynecology and Obstetrics (FIGO) 2018 Stage 3A-4A
6. At least one measurable tumor lesion per RECIST v1.1
7. Adequate organ function as assessed in the laboratory tests

Exclusion Criteria:

1. Subjects with other histopathological types of cervical cancer, such as small cell carcinoma, sarcoma, etc.
2. FIGO 2018 IVB
3. Subjects who had previously undergone total hysterectomy
4. Subjects who cannot receive brachytherapy
5. Subjects with other active malignancies within 2 years prior to randomization
6. Clinically significant hydronephrosis that cannot be relieved by nephrostomy or ureteral stenting as judged by the Investigator
7. 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).
8. 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;
9. Major surgical treatment, open biopsy or significant trauma within 4 weeks prior to randomization; or elective major surgical treatment required during the study
10. Use of live vaccines within 4 weeks prior to randomization
11. Active or potentially recurrent autoimmune disease
12. Known primary or secondary immunodeficiencies, including testing positive for human immunodeficiency virus (HIV) antibodies
13. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
14. Known history of interstitial lung disease or non-infectious pneumonitis
15. Pregnant or lactating women.
16. Any condition that, in the opinion of the Investigator, may result in a risk when receiving the study drug.

Primary outcomes:
measure: Progression-Free Survival(PFS) by investigator(INV)
timeFrame: 54 months
Secondary outcomes:
measure: PFS rate at month 36
timeFrame: 36 months
measure: Overall Survival(OS)
timeFrame: 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Guiyang
country: China
facility: Guizhou Cancer Hospital
state: Guizhou
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Changsha
country: China
facility: Hunan cancer hospital
state: Hunan
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Chengdu
country: China
facility: West China Second University Hospital
state: Sichuan
city: Hangzhou
country: China
facility: Women's Hospital School Of Medicine Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Sun Yat-sen University
name: Jihong Liu, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking Union Medical College Hospital
name: Yang Xiang, MD
role: PRINCIPAL_INVESTIGATOR
References: