Locally Advanced Cervical Carcinoma
Conditions
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
Interventions
Sponsors
Akeso
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed