AK104 Combined With Chemotherapy as Neoadjuvant Treatment for Advanced Ovarian Cancer

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Drug: AK104 - Chemotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AK104+chemotherapy<br>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 | Drug: AK104 - Chemotherapy<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete(R0) resection rate | The margin of the resected specimen showed no tumour involvement | Average 4 months after the start of drugs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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 | 
| 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 | 
| Number of participants with adverse events (AEs) |  | From the first dose of neoadjuvant treatment until 90 days after the last dose of neoadjuvant treatment | 
| Number of participants with surgical complications |  | Intraoperatively, within 30 days after surgery |