AK104 Combined With Chemotherapy as Neoadjuvant Treatment for Advanced Ovarian Cancer

NCT ID: NCT05430906

Last Updated: 2023-04-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-25
• Study Completion Date: 2026-01-31

Brief Summary

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

Ovarian Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AK104+chemotherapy

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

Group Type: EXPERIMENTAL

AK104 - Chemotherapy

Intervention Type: DRUG

AK104 10mg/kg then \[paclitaxel (135-175 mg/m²) or docetaxel (75 mg/m²)\] and \[carboplatin (AUC5 or 6) or cisplatin (75mg/m²)\] of each 21-day cycle

Interventions

AK104 - Chemotherapy

AK104 10mg/kg then \[paclitaxel (135-175 mg/m²) or docetaxel (75 mg/m²)\] and \[carboplatin (AUC5 or 6) or cisplatin (75mg/m²)\] of each 21-day cycle

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hunan Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jie Tang

Role: STUDY_CHAIR

Hunan Cancer Hospital

Locations

Hunan Cancer hospital

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jie Tang

Role: CONTACT

tangjie@hnca.org.cn

+8615274836636

Facility Contacts

Jie Tang

Role: primary

References

Zhang 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.

Reference Type: DERIVED

PMID: 40600147 (View on PubMed)

Other Identifiers

AK104-IIT-003

Identifier Type: -

Identifier Source: org_study_id