AK104 Combined With Chemotherapy as Neoadjuvant Treatment for Advanced Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT05430906|
Recruitment Status : Not yet recruiting
First Posted : June 24, 2022
Last Update Posted : June 24, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: AK104 - Chemotherapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||July 2022|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||January 2026|
Participants received 3-4 neo-adjuvant cycles of standard 3 weekly AK104 10mg/kg then [paclitaxel (135-175 mg/m²) or docetaxel (75 mg/m²)] and [carboplatin (AUC5 or 6) or cisplatin (75mg/m²)]; followed by surgery
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
- Complete(R0) resection rate [ Time Frame: Average 4 months after the start of drugs ]The margin of the resected specimen showed no tumour involvement
- Objective Response Rate (ORR) [ Time Frame: 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) [ Time Frame: 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.
- Pathological Complete Response (pCR) Rate [ Time Frame: 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.
- Progression-free survival (PFS) [ Time Frame: 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) [ Time Frame: From the first dose of neoadjuvant treatment until 90 days after the last dose of neoadjuvant treatment ]
- Number of participants with surgical complications [ Time Frame: Intraoperatively, within 30 days after surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05430906
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