AK104 in Neoadjuvant Treatment of Cervical Cancer

Cervical Cancer Clinical Trial

Official title:

Phase II Study on AK104 in Neoadjuvant Treatment of Cervical Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05227651
• Other study ID #: AK104-214
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 30, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: January 2022
• Source: Akeso
• Contact: Weifeng Song, MD
• Phone: +86(0760)89873999
• Email: clinicaltrials[@]akesobio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• AK104
IV infusion,Specified dose on specified days

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hanzhong	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Akeso

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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