AK104 Combined With Chemotherapy as Neoadjuvant Treatment for Advanced Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05430906
• Other study ID #: AK104-IIT-003
• Status: Recruiting
• Phase: Phase 2
• Start date: November 25, 2022
• Est. completion date: January 2026

Study information

• Verified date: February 2023
• Source: Hunan Cancer Hospital
• Contact: Jie Tang
• Phone: +8615274836636
• Email: tangjie[@]hnca.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2026
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Hunan Cancer hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Hunan Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete(R0) resection rate	The margin of the resected specimen showed no tumour involvement	Average 4 months after the start of drugs
Secondary	Objective Response Rate (ORR)	The ORR is defined as the percentage of participants having complete response or partial response to protocol treatment. Objective response will be measured by RECIST 1.1.	At the end of 3-4 cycles of neoadjuvant therapy (each cycle is 21 days)
Secondary	Disease control rate (DCR)	The DCR is defined as the proportion of subjects with complete response, partial response, or stable disease based on RECIST Version 1.1.	At the end of 3-4 cycles of neoadjuvant therapy (each cycle is 21 days)
Secondary	Pathological Complete Response (pCR) Rate	The pCR is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.	One week after the surgery
Secondary	Progression-free survival (PFS)	Progression-free survival is defined as the time from the start of drugs until the first documentation of disease progression or death due to any cause, whichever occurs first.	From the date of the start of drugs to date event, assessed up to 1 years
Secondary	Number of participants with adverse events (AEs)		From the first dose of neoadjuvant treatment until 90 days after the last dose of neoadjuvant treatment
Secondary	Number of participants with surgical complications		Intraoperatively, within 30 days after surgery