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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• \- 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.

Locations
Other Locations
China
Hunan Cancer hospital
RECRUITING
Changsha
Contact Information
Primary
Jie Tang
tangjie@hnca.org.cn
+8615274836636
Time Frame
Start Date: 2022-11-25
Estimated Completion Date: 2026-01
Participants
Target number of participants: 40
Treatments
Experimental: 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
Related Therapeutic Areas
Sponsors
Leads: Hunan Cancer Hospital

This content was sourced from clinicaltrials.gov