Clinical trial · Interventional
AK104 Combined With Chemotherapy as Neoadjuvant Treatment for Advanced Ovarian Cancer
Efficacy and Safety of AK104 (PD-1/CTLA-4 Bispecific Antibody) Combined With Chemotherapy as Neoadjuvant Treatment for Advanced Ovarian Cancer: a Single-arm, Open-label, Multicenter Clinical Study
- 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)
Previous studies have suggested that immunotherapy combined with chemotherapy as neoadjuvant treatment for ovarian cancer may have a synergistic effect and a manageable safety profile. AK104 is a bispecific antibody targeting PD-1 and CTLA-4. Therefore, this study aimed to evaluate the efficacy and safety of AK104 combined with chemotherapy as the neoadjuvant treatment for advanced ovarian 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 |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AK104 - Chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AK104+chemotherapy
- description
- Participants received 3-4 neo-adjuvant cycles of AK104 10mg/kg Q3W then \[paclitaxel (135-175 mg/m²) or docetaxel (75 mg/m²)\] and \[carboplatin (AUC5 or 6) or cisplatin (75mg/m²)\] Q3W; followed by surgery
- interventionNames
- Drug: AK104 - Chemotherapy
Primary outcomes (1)
- measure
- Complete(R0) resection rate
- timeFrame
- Average 4 months after the start of drugs
- description
- The margin of the resected specimen showed no tumour involvement
Secondary outcomes (6)
- measure
- Objective Response Rate (ORR)
- timeFrame
- At the end of 3-4 cycles of neoadjuvant therapy (each cycle is 21 days)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Key Inclusion Criteria: \- 1. Woman ≥ 18 and ≤ 75 years old on day of signing informed consent. 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 3. Advanced FIGO stage III to IV patient not able to receive primary debulking surgery for which neo adjuvant chemotherapy is recommended. 4\. Have at least one measurable lesion per RECIST 1.1 assessed by investigator. 5. Have adequate organ function. Key Exclusion Criteria: * 1\. Histological diagnosis of malignant tumor of non-epithelial origin of the ovary, the fallopian tube or peritoneum or borderline tumor of the ovary. 2\. Patients with other active malignancies within 5 years prior to enrollment. 3. Known active autoimmune diseases. 4. Use of immunosuppressive agents within 14 days prior to the first dose of study treatment. 5\. Presence of other uncontrolled serious medical conditions.
References
Publications (1)
- DERIVEDZhang C, Dai M, Yang J, Tian W, Huang S, Bi F, Zheng K, Tang J. Patient with HR-proficient advanced ovarian cancer achieved a complete response with Cadonilimab combined chemotherapy (PD-1/CTLA-4 bispecific): a case report and literature review. Gynecol Oncol Rep. 2025 Jun 15;60:101785. doi: 10.1016/j.gore.2025.101785. eCollection 2025 Aug. PMID 40600147