AK104 Combined With Chemotherapy as Neoadjuvant Treatment for Advanced Ovarian Cancer

Phase 2

Recruiting

• Conditions: Ovarian Cancer
• Interventions: Drug: AK104 - Chemotherapy

• Registration Number: NCT05430906
• Lead Sponsor: Hunan Cancer Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-20
• Study First Submitted QC: 2022-06-20
• Study First Posted: 2022-06-24
• Study Start: 2022-11-25
• Status Verified: 2023-02
• Last Update Submitted: 2023-04-24
• Last Update Posted: 2023-04-25
• Primary Completion: 2023-12
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

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.

  3. Presence of other uncontrolled serious medical conditions.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AK104+chemotherapy	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

Primary Outcome Measures

Name	Time	Method
Complete(R0) resection rate	Average 4 months after the start of drugs	The margin of the resected specimen showed no tumour involvement

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	At the end of 3-4 cycles of neoadjuvant therapy (each cycle is 21 days)	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.
Disease control rate (DCR)	At the end of 3-4 cycles of neoadjuvant therapy (each cycle is 21 days)	The DCR is defined as the proportion of subjects with complete response, partial response, or stable disease based on RECIST Version 1.1.
Progression-free survival (PFS)	From the date of the start of drugs to date event, assessed up to 1 years	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.
Number of participants with adverse events (AEs)	From the first dose of neoadjuvant treatment until 90 days after the last dose of neoadjuvant treatment
Pathological Complete Response (pCR) Rate	One week after the surgery	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.
Number of participants with surgical complications	Intraoperatively, within 30 days after surgery

Trial Locations

Locations (1)

Hunan Cancer hospital; 🇨🇳 Changsha, Hunan, China