A Study of Concurrent Chemoradiotherapy Followed by Cadonilimab（AK104） for Newly Diagnosed Local Advanced Cervical Cancer

February 1, 2024 updated by: Rutie Yin, West China Second University Hospital

A Prospective, Single Arm, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of Concurrent Chemoradiotherapy Followed by Cadonilimab（AK104) for Newly Diagnosed Local Advanced Cervical Cancer

This study will evaluate the efficacy and safety of concurrent chemoradiotherapy（CCRT）followed by cadonilimab（AK104) in high risk local advanced cervical cancer.

Participants received CCRT，efficacy evaluation of CCRT was no disease progression who maintained with AK104（10.0 mg/kg，Q3W）until drug exposure over 1 years or disease progression or intolerable toxicity.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

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
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Second University Hospital
        • Contact:
        • Principal Investigator:
          • Rutie Yin, Clinical Professor

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Voluntary agreement to provide written informed consent.
  • female, Age 18 -75 years.
  • Predicted survival ≥ 3 month.
  • Histologically and/or cytologically confirmed Squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma, FIGO 2018 stage III-IVA.
  • Unable to undergo curative surgery，Pior not received systemic therapy before CCRT, Including but not limited to radiotherapy, chemotherapy, immunotherapy, and biological therapy,etc.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  • Have at least one evaluable lesion (RECIST 1.1 criteria)
  • Adequate organ function, evidenced by the following laboratory results within 7 days prior to the study treatment.
  • participants are eligible to participate if they agree to the contraception use as per study protocol.
  • Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol.

Exclusion Criteria:

  • Has received other antitumor therapy before CCRT.
  • Therapeutic evaluation of CCRT was disease progression.
  • Previously received immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.), immune checkpoint agonists (such as ICOS, CD40, CD137, GITR, and Ox40 . etc.), immune cell therapy. etc. Any tumor immune mechanisms treatment .
  • With brain metastases.
  • Previously received allogeneic stem cell or parenchymal organ transplantation.
  • Previously or currently suffering from congenital or acquired immunodeficiency diseases.
  • known or suspected to have a history of allergies to similar drugs, or has a history of hypersensitivity to chimeric or humanized antibodies or fusion proteins, or is allergic to excipients of the study drug.
  • Diagnosed with HBsAg, HBcAb positive and HBV DNA copy positive, or HCVAb positive, or HIVAb positive.
  • Has received a live virus vaccine within 4 weeks of planned start of trial treatment.
  • Within the 6 months prior to enrollment, has serious cardiovascular events such as pulmonary embolism, acute myocardial infarction, congestive heart failure (New York Heart Association grade III or IV), and ≥ 2 grade ventricular arrhythmias.
  • Cerebrovascular accident within 6 months prior to enrollment.
  • Active infection requiring systemic treatment.
  • Uncontrolled hypertension, diabetes, Interstitial lung Disease, non infectious pneumonia , pulmonary fibrosis, acute lung disease, etc.
  • Required systemic treatment with glucocorticoid (>10 mg/day of prednisone or equivalent glucocorticoid) or other immunosuppressive agents within 14 days prior to enter the trial.
  • History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or cancers with a similar curative outcome as those mentioned above.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Pregnancy or lactation.
  • Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.

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: treatment group
AK104（10.0 mg/kg，intravenous (IV) infusion，Q3W） after CCRT
Drug: AK104
AK104（10.0 mg/kg，intravenous (IV) infusion，Q3W）maintained with no more than 1 year.
Other Names:
  • Cadonilimab Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: Baseline up to approximately 24 months.
Progression-free survival is defined as the time from the start of treatment with AK104 until the first documentation of disease progression or death due to any cause, whichever occurs first.
Baseline up to approximately 24 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate assessed by Investigator
Time Frame: Baseline up to approximately 12 months.
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR per RECIST v1.1.
Baseline up to approximately 12 months.
Disease control rate
Time Frame: Baseline up to approximately 12 months.
The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1.
Baseline up to approximately 12 months.
Overall survival
Time Frame: Baseline up to approximately 48 months.
OS is the time from randomization to death due to any cause
Baseline up to approximately 48 months.
Safety and adverse reactions of Cadonilimab
Time Frame: Baseline up to approximately 48 months.
According to CTCAE v5.0, any adverse events that occur to all subjects during the study period will be recorded. We recorded the clinical manifestation characteristics, severity, onset time, duration, treatment method and prognosis, and determined the correlation with Cadonilimab.
Baseline up to approximately 48 months.

Collaborators and Investigators

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

Sponsor

West China Second University Hospital

Collaborators

The Affiliated Hospital Of Southwest Medical University
Affiliated Hospital of North Sichuan Medical College

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 (Estimated)

February 20, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

January 26, 2024

First Submitted That Met QC Criteria

February 1, 2024

First Posted (Estimated)

February 9, 2024

Study Record Updates

Last Update Posted (Estimated)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 1, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WCSUH20231212

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 Cervical Cancer

Clinical Trials on AK104

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe