NCT05430906

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2 ovarian-cancer

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 24, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

November 25, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

April 25, 2023

Status Verified

February 1, 2023

Enrollment Period

1 year

First QC Date

June 20, 2022

Last Update Submit

April 24, 2023

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

  • Complete(R0) resection rate

    The margin of the resected specimen showed no tumour involvement

    Average 4 months after the start of drugs

Secondary Outcomes (6)

  • Objective Response Rate (ORR)

    At the end of 3-4 cycles of neoadjuvant therapy (each cycle is 21 days)

  • Disease control rate (DCR)

    At the end of 3-4 cycles of neoadjuvant therapy (each cycle is 21 days)

  • Pathological Complete Response (pCR) Rate

    One week after the surgery

  • Progression-free survival (PFS)

    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

  • +1 more secondary outcomes

Study Arms (1)

AK104+chemotherapy

EXPERIMENTAL

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

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

AK104+chemotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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.
  • \. Have at least one measurable lesion per RECIST 1.1 assessed by investigator. 5. Have adequate organ function.

You may not qualify if:

  • \. Histological diagnosis of malignant tumor of non-epithelial origin of the ovary, the fallopian tube or peritoneum or borderline tumor of the ovary.
  • \. 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.
  • \. Presence of other uncontrolled serious medical conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hunan Cancer hospital

Changsha, Hunan, 410000, China

RECRUITING

Related Publications (1)

  • Zhang C, Dai M, Yang J, Tian W, Huang S, Bi F, Zheng K, Tang J. Patient with HR-proficient advanced ovarian cancer achieved a complete response with Cadonilimab combined chemotherapy (PD-1/CTLA-4 bispecific): a case report and literature review. Gynecol Oncol Rep. 2025 Jun 15;60:101785. doi: 10.1016/j.gore.2025.101785. eCollection 2025 Aug.

    PMID: 40600147DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Jie Tang

    Hunan Cancer Hospital

    STUDY CHAIR

Central Study Contacts

Jie Tang

CONTACT

+8615274836636tangjie@hnca.org.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2022

First Posted

June 24, 2022

Study Start

November 25, 2022

Primary Completion

December 1, 2023

Study Completion

January 1, 2026

Last Updated

April 25, 2023

Record last verified: 2023-02

Locations

CN(1)