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

West China Second University Hospital1 site in 1 country50 target enrollmentFebruary 20, 2024

ConditionsCervical Cancer

InterventionsAK104

DrugsAK104

Overview

Phase: Phase 2
Intervention: AK104
Conditions: Cervical Cancer
Sponsor: West China Second University Hospital
Enrollment: 50
Locations: 1
Primary Endpoint: Progression-free survival
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

February 20, 2024

End Date

October 1, 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

West China Second University Hospital

Responsible Party

Principal Investigator

Rutie Yin

Clinical Professor

West China Second University Hospital

Eligibility Criteria

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
•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.

Arms & Interventions

treatment group

AK104（10.0 mg/kg，intravenous (IV) infusion，Q3W） after CCRT

Intervention: AK104

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Objective response rate assessed by Investigator(Baseline up to approximately 12 months.)
Overall survival(Baseline up to approximately 48 months.)
Safety and adverse reactions of Cadonilimab(Baseline up to approximately 48 months.)
Disease control rate(Baseline up to approximately 12 months.)