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

Primary Purpose

Locally Advanced Cervical Carcinoma

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
AK104
EBRT
BT
cisplatin
Placebo
Sponsored by
Akeso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced Cervical Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking Union Medical College HospitalRecruiting
  • Fujian Provincial Cancer Hospital
  • Guizhou Cancer Hospital
  • Hubei Cancer Hospital
  • Xiangya Hospital Central South University
  • Hunan cancer hospital
  • Fudan University Shanghai Cancer Center
  • West China Second University Hospital
  • Women's Hospital School Of Medicine Zhejiang University
  • Zhejiang Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

treatment arm

placebo arm

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

PFS rate at month 36
PFS rate at month 36
Overall Survival(OS)
OS is defined as the time from randomization to death due to any cause.

Full Information

First Posted
January 20, 2022
Last Updated
August 22, 2022
Sponsor
Akeso
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1. Study Identification

Unique Protocol Identification Number
NCT05235516
Brief Title
A Study of AK104/Placebo Combined With Chemoradiotherapy For The Treatment of Locally Advanced Cervical Cancer
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 21, 2022 (Actual)
Primary Completion Date
May 2026 (Anticipated)
Study Completion Date
May 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Akeso

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Cervical Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
636 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment arm
Arm Type
Experimental
Arm Title
placebo arm
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AK104
Intervention Description
q3w iv
Intervention Type
Radiation
Intervention Name(s)
EBRT
Intervention Description
45-50.4Gy
Intervention Type
Radiation
Intervention Name(s)
BT
Intervention Description
≥80Gy
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
qw iv
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
q3w iv
Primary Outcome Measure Information:
Title
Progression-Free Survival(PFS) by investigator(INV)
Description
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
Time Frame
54 months
Secondary Outcome Measure Information:
Title
PFS rate at month 36
Description
PFS rate at month 36
Time Frame
36 months
Title
Overall Survival(OS)
Description
OS is defined as the time from randomization to death due to any cause.
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ting Liu, MD
Phone
+86 (0760) 8987 3999
Email
clinicaltrials@akesobio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jihong Liu, Ph.D
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yang Xiang, MD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100005
Country
China
Individual Site Status
Recruiting
Facility Name
Fujian Provincial Cancer Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Guizhou Cancer Hospital
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
550000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Hubei Cancer Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Xiangya Hospital Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Hunan cancer hospital
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaohua Wu, MD
First Name & Middle Initial & Last Name & Degree
Xiaohua Wu, MD
Facility Name
West China Second University Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Women's Hospital School Of Medicine Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310005
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310005
Country
China
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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