Cervical Cancer
Conditions
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.
Interventions
DRUGAK104
IV infusion,Specified dose on specified days
Sponsors
Akeso
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age≥18 & ≤75. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 3. Histologically or cytologically confirmed diagnosis of primary cervical squamous cell carcinoma. 4. According to the 2018 International Federation of Cervical Cancer Obstetrics and Gynecology (FIGO) staging standard, the patient was diagnosed in stage IB2-IIA2. 5. Has not received any treatment before. 6. Has at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator. 7. Has adequate organ function.
Exclusion criteria
1. 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. 2. Active Hepatitis B or Hepatitis C. 3. History of severe bleeding tendency or coagulation disorder. 4. Undergone major surgery within 30 days prior to the first dose of study treatment. 5. Pregnant or lactating female patients. 6. Drug or alcohol abuse. 7. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events (AEs) | Up to approximately 6 mouths | 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 | within 14 working days after operation | MPR rate is defined as the percentage of participants having ≤ 10% viable tumor cells in the pathological examination of resected specimens. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| R0 resection rate | within 14 working days after operation | 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 | within 14 working days after operation | 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) | 4-6 weeks after the first cycle of neoadjuvant treatment | 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. |
Countries
China
Outcome results
None listed