Back to resultsAK104 in Neoadjuvant Treatment of Cervical Cancer
Primary Purpose
Cervical Cancer
Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
AK104
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Cancer
Eligibility Criteria
Inclusion Criteria:
- Age≥18 & ≤75.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Histologically or cytologically confirmed diagnosis of primary cervical squamous cell carcinoma.
- According to the 2018 International Federation of Cervical Cancer Obstetrics and Gynecology (FIGO) staging standard, the patient was diagnosed in stage IB2-IIA2.
- Has not received any treatment before.
- Has at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator.
- Has adequate organ function.
Exclusion Criteria:
- Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Active Hepatitis B or Hepatitis C.
- History of severe bleeding tendency or coagulation disorder.
- Undergone major surgery within 30 days prior to the first dose of study treatment.
- Pregnant or lactating female patients.
- Drug or alcohol abuse.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of this subject to participate, in the opinion of the treating investigator.
Sites / Locations
- Zhejiang Cancer Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AK104
Arm Description
Patients will be treated with 1-2 cycles of neoadjuvant AK104. 4-6 weeks after the first cycle of neoadjuvant treatment, patients will undergo radical surgery.
Outcomes
Primary Outcome Measures
Adverse Events (AEs)
The number of participants experiencing an AE will be assessed. An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy.
Major pathological response (MPR) rate
MPR rate is defined as the percentage of participants having ≤ 10% viable tumor cells in the pathological examination of resected specimens.
Secondary Outcome Measures
R0 resection rate
R0 resection rate is defined as the percentage of patients whose post-operative pathology indicate complete tumor resection with all margins being negative.
Pathological Complete Response (pCR) rate
pCR rate is defined as the percentage of participants lacking of evidence of viable tumor cells in the pathological examination of resected specimens.
Objective response rates (ORR)
ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05227651
Brief Title
AK104 in Neoadjuvant Treatment of Cervical Cancer
Official Title
Phase II Study on AK104 in Neoadjuvant Treatment of Cervical Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 30, 2022 (Anticipated)
Primary Completion Date
March 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (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
5. Study Description
Brief Summary
Phase II open label study to evaluate the safety and efficacy of AK104 (anti-PD-1 and CTLA-4 bispecific antibody) in neoadjuvant treatment of cervical cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AK104
Arm Type
Experimental
Arm Description
Patients will be treated with 1-2 cycles of neoadjuvant AK104. 4-6 weeks after the first cycle of neoadjuvant treatment, patients will undergo radical surgery.
Intervention Type
Drug
Intervention Name(s)
AK104
Intervention Description
IV infusion,Specified dose on specified days
Primary Outcome Measure Information:
Title
Adverse Events (AEs)
Description
The number of participants experiencing an AE will be assessed. An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy.
Time Frame
Up to approximately 6 mouths
Title
Major pathological response (MPR) rate
Description
MPR rate is defined as the percentage of participants having ≤ 10% viable tumor cells in the pathological examination of resected specimens.
Time Frame
within 14 working days after operation
Secondary Outcome Measure Information:
Title
R0 resection rate
Description
R0 resection rate is defined as the percentage of patients whose post-operative pathology indicate complete tumor resection with all margins being negative.
Time Frame
within 14 working days after operation
Title
Pathological Complete Response (pCR) rate
Description
pCR rate is defined as the percentage of participants lacking of evidence of viable tumor cells in the pathological examination of resected specimens.
Time Frame
within 14 working days after operation
Title
Objective response rates (ORR)
Description
ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Time Frame
4-6 weeks after the first cycle of neoadjuvant treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age≥18 & ≤75.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Histologically or cytologically confirmed diagnosis of primary cervical squamous cell carcinoma.
According to the 2018 International Federation of Cervical Cancer Obstetrics and Gynecology (FIGO) staging standard, the patient was diagnosed in stage IB2-IIA2.
Has not received any treatment before.
Has at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator.
Has adequate organ function.
Exclusion Criteria:
Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
Active Hepatitis B or Hepatitis C.
History of severe bleeding tendency or coagulation disorder.
Undergone major surgery within 30 days prior to the first dose of study treatment.
Pregnant or lactating female patients.
Drug or alcohol abuse.
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of this subject to participate, in the opinion of the treating investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weifeng Song, MD
Phone
+86(0760)89873999
Email
clinicaltrials@akesobio.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hanmei Lou, MD
Phone
0571-88122042
Email
louhm@zjcc.org.com
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hanzhong
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanmei Lou, MD
Phone
0571-88122042
Email
louhm@zjcc.org.cn
First Name & Middle Initial & Last Name & Degree
Aijun Yu, MD
Phone
0571-88128122
Email
Yaj1993@126.com
12. IPD Sharing Statement
Learn more about this trial
AK104 in Neoadjuvant Treatment of Cervical Cancer
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