NCT05227651CompletedPhase 2
AK104 in Neoadjuvant Treatment of Cervical Cancer
Phase II Study on AK104 in Neoadjuvant Treatment of Cervical Cancer
Source: ClinicalTrials.gov · Last updated 1 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 14 (actual)
- First submitted
- 27 Jan 2022
- Start date
- 10 Feb 2023
- Primary completion date
- 27 Sept 2024
- Lead sponsor
- Akeso
- Diseases
- Cervical cancer
- NCT number
- NCT05227651
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 14
- From 10 Feb 2023 to the primary completion date, 27 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Undergone major surgery within 30 days prior to the first dose of study treatment.
- Drug or alcohol abuse.
Other illness
- 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.
Lab values
- 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.
Other
- Pregnant or lactating female patients.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hanzhong | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.