AK104 in Neoadjuvant Treatment of Cervical Cancer

NCT05227651 | Completed Phase 2

• 1 other identifier: AK104-214
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• R0 resection rate

  within 14 working days after operation

• Pathological Complete Response (pCR) rate

  within 14 working days after operation

• Objective response rates (ORR)

  4-6 weeks after the first cycle of neoadjuvant treatment

Study Arms (1)

AK104

EXPERIMENTAL

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

Interventions

AK104 DRUG

IV infusion,Specified dose on specified days

AK104

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hanzhong, Zhejiang, 310022, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 7, 2022
• Study Start: February 10, 2023
• Primary Completion: September 27, 2024
• Study Completion: September 27, 2024
• Last Updated: November 1, 2024

Record last verified: 2024-10

Locations

CN (1)