A Study of AK104/Placebo Combined With Chemoradiotherapy For The Treatment of Locally Advanced Cervical Cancer

Locally Advanced Cervical Carcinoma Clinical Trial

— AK104-305  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05235516
• Other study ID #: AK104- 305
• Status: Recruiting
• Phase: Phase 3
• Start date: June 21, 2022
• Est. completion date: May 2029

Study information

• Verified date: August 2022
• Source: Akeso
• Contact: Ting Liu, MD
• Phone: +86 (0760) 8987 3999
• Email: clinicaltrials[@]akesobio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 636
• Est. completion date: May 2029
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Locally Advanced Cervical Carcinoma
• Uterine Cervical Neoplasms

Intervention

Drug:
• AK104
q3w iv

Radiation:
• EBRT
45-50.4Gy
• BT
=80Gy

Drug:
• cisplatin
qw iv
• Placebo
q3w iv

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Hunan cancer hospital	Changsha	Hunan
China	Xiangya Hospital Central South University	Changsha	Hunan
China	West China Second University Hospital	Chengdu	Sichuan
China	Fujian Provincial Cancer Hospital	Fuzhou	Fujian
China	Guizhou Cancer Hospital	Guiyang	Guizhou
China	Women's Hospital School Of Medicine Zhejiang University	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Hubei Cancer Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Akeso

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival(PFS) by investigator(INV)	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	54 months
Secondary	PFS rate at month 36	PFS rate at month 36	36 months
Secondary	Overall Survival(OS)	OS is defined as the time from randomization to death due to any cause.	5 years