AK104 Combined With Chemotherapy as Neoadjuvant Treatment for Advanced Ovarian Cancer

April 24, 2023 updated by: Hunan Cancer Hospital

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410000
        • Recruiting
        • Hunan Cancer Hospital
        • Contact:
          • Jie Tang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AK104+chemotherapy
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete(R0) resection rate
Time Frame: Average 4 months after the start of drugs
The margin of the resected specimen showed no tumour involvement
Average 4 months after the start of drugs

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the end of 3-4 cycles of neoadjuvant therapy (each cycle is 21 days)
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.
At the end of 3-4 cycles of neoadjuvant therapy (each cycle is 21 days)
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.
One week after the surgery
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.
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
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
Intraoperatively, within 30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hunan Cancer Hospital

Investigators

  • Study Chair: Jie Tang, Hunan Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2022

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

January 1, 2026

Study Registration Dates

First Submitted

June 20, 2022

First Submitted That Met QC Criteria

June 20, 2022

First Posted (Actual)

June 24, 2022

Study Record Updates

Last Update Posted (Actual)

April 25, 2023

Last Update Submitted That Met QC Criteria

April 24, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AK104-IIT-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ovarian Cancer

Clinical Trials on AK104 - Chemotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe