Clinical trial · Interventional
AK104 in Neoadjuvant Treatment of Cervical Cancer
Phase II Study on AK104 in Neoadjuvant Treatment of Cervical Cancer
NCT05227651CI-TRIAL-00082142completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AK104 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AK104
- description
- 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.
- interventionNames
- Drug: AK104
Primary outcomes (2)
- measure
- Adverse Events (AEs)
- timeFrame
- Up to approximately 6 mouths
- description
- 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.
- measure
- Major pathological response (MPR) rate
- timeFrame
- within 14 working days after operation
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.