AK104-305: A Study of AK104/Placebo Combined With Chemoradiotherapy For The Treatment of Locally Advanced Cervical Cancer

• Sponsor: Akeso (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05235516
• Collaborator: (none)
• Enrollment: 636
• Locations: 10
• Arms: 2
• Anticipated Duration (Months): 82.3
• Patients Per Site: 63.6
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Locally Advanced Cervical Carcinoma	Drug: AK104; Radiation: EBRT; Radiation: BT; Drug: cisplatin; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 636 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jun 21, 2022
• Anticipated Primary Completion Date: May 1, 2026
• Anticipated Study Completion Date: May 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
Experimental: treatment arm	Drug: AK104; q3w iv; Radiation: EBRT; 45-50.4Gy; Radiation: BT; ≥80Gy; Drug: cisplatin; qw iv
Placebo Comparator: placebo arm	Radiation: EBRT; 45-50.4Gy; Radiation: BT; ≥80Gy; Drug: cisplatin; qw iv; Drug: Placebo; q3w iv

Outcome Measures

Primary Outcome Measures

1. 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

1. PFS rate at month 36 [36 months]

   PFS rate at month 36

2. Overall Survival(OS) [5 years]

   OS is defined as the time from randomization to death due to any cause.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking Union Medical College Hospital	Beijing	Beijing	China	100005
2	Fujian Provincial Cancer Hospital	Fuzhou	Fujian	China	350014
3	Guizhou Cancer Hospital	Guiyang	Guizhou	China	550000
4	Hubei Cancer Hospital	Wuhan	Hubei	China	430079
5	Xiangya Hospital Central South University	Changsha	Hunan	China	410013
6	Hunan cancer hospital	Changsha	Hunan	China
7	Fudan University Shanghai Cancer Center	Shanghai	Shanghai	China	200032
8	West China Second University Hospital	Chengdu	Sichuan	China	610041
9	Women's Hospital School Of Medicine Zhejiang University	Hangzhou	Zhejiang	China	310005
10	Zhejiang Cancer Hospital	Hangzhou	Zhejiang	China	310005

Sponsors and Collaborators

• Akeso

Investigators

• Principal Investigator: Jihong Liu, Ph.D, Sun Yat-sen University
• Principal Investigator: Yang Xiang, MD, Peking Union Medical College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Akeso
• ClinicalTrials.gov Identifier: NCT05235516
• Other Study ID Numbers: AK104- 305
• First Posted: Feb 11, 2022
• Last Update Posted: Aug 24, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Uterine Cervical Neoplasms; Cisplatin

Study Results

No Results Posted as of Aug 24, 2022