Back to resultsAK104 Combined With Chemotherapy as Neoadjuvant Treatment for Advanced Ovarian Cancer
Primary Purpose
Ovarian Cancer
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
AK104 - Chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer
Eligibility Criteria
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.
Sites / Locations
- Hunan Cancer hospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AK104+chemotherapy
Arm Description
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
Outcomes
Primary Outcome Measures
Complete(R0) resection rate
The margin of the resected specimen showed no tumour involvement
Secondary Outcome Measures
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.
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.
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.
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.
Number of participants with adverse events (AEs)
Number of participants with surgical complications
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05430906
Brief Title
AK104 Combined With Chemotherapy as Neoadjuvant Treatment for Advanced Ovarian Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 25, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
January 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hunan Cancer Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AK104+chemotherapy
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
AK104 - Chemotherapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Complete(R0) resection rate
Description
The margin of the resected specimen showed no tumour involvement
Time Frame
Average 4 months after the start of drugs
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
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.
Time Frame
At the end of 3-4 cycles of neoadjuvant therapy (each cycle is 21 days)
Title
Disease control rate (DCR)
Description
The DCR is defined as the proportion of subjects with complete response, partial response, or stable disease based on RECIST Version 1.1.
Time Frame
At the end of 3-4 cycles of neoadjuvant therapy (each cycle is 21 days)
Title
Pathological Complete Response (pCR) Rate
Description
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.
Time Frame
One week after the surgery
Title
Progression-free survival (PFS)
Description
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.
Time Frame
From the date of the start of drugs to date event, assessed up to 1 years
Title
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
Title
Number of participants with surgical complications
Time Frame
Intraoperatively, within 30 days after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jie Tang
Phone
+8615274836636
Email
tangjie@hnca.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jie Tang
Organizational Affiliation
Hunan Cancer Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Hunan Cancer hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Tang
12. IPD Sharing Statement
Learn more about this trial
AK104 Combined With Chemotherapy as Neoadjuvant Treatment for Advanced Ovarian Cancer
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