AK104 in Neoadjuvant Treatment of Cervical Cancer

Phase II Study on AK104 in Neoadjuvant Treatment of Cervical Cancer

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.

Study Overview

• Status: Completed
• Conditions: Cervical Cancer
• Intervention / Treatment: Drug: AK104

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hanzhong, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AK104; Patients will be treated with 1-4 cycles of neoadjuvant AK104. 2-4 weeks after the last cycle of neoadjuvant treatment, patients will undergo radical surgery.	Drug: AK104; IV infusion,Specified dose on specified days

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Akeso

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2023
• Primary Completion (Actual): September 27, 2024
• Study Completion (Actual): September 27, 2024

Study Registration Dates

• First Submitted: January 27, 2022
• First Submitted That Met QC Criteria: January 27, 2022
• First Posted (Actual): February 7, 2022

Study Record Updates

• Last Update Posted (Estimated): November 1, 2024
• Last Update Submitted That Met QC Criteria: October 30, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Uterine Cervical Neoplasms
• Other Study ID Numbers: AK104-214

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No