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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05430906
Other study ID # AK104-IIT-003
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


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
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