AK104 Combined With Chemotherapy as Neoadjuvant Treatment for Advanced Ovarian Cancer

Hunan Cancer Hospital40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ovarian Cancer

Interventions

AK104 - ChemotherapyDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hunan Cancer hospital

Changsha, Hunan, China

RECRUITING

Outcomes

Primary Outcomes

Complete(R0) resection rate

The margin of the resected specimen showed no tumour involvement

Time frame: Average 4 months after the start of drugs

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: From the date of the start of drugs to date event, assessed up to 1 years

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

Central Contacts

Jie Tang

CONTACT

+8615274836636 tangjie@hnca.org.cn

Data from ClinicalTrials.gov

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