AK104 in Neoadjuvant Treatment of Cervical Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Phase II Study on AK104 in Neoadjuvant Treatment of Cervical Cancer

Conditions
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Cervical Cancer

Intervention / Treatment
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* Drug: AK104


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AK104<br>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. | Drug: AK104<br>* IV infusion,Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to approximately 6 mouths | 
| 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. | within 14 working days after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | within 14 working days after operation | 
| 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. | within 14 working days after operation | 
| 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. | 4-6 weeks after the first cycle of neoadjuvant treatment |