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

NCT06251388 | Recruiting Phase 2

• 1 other identifier: WCSUH20231212
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  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 Outcomes (4)

• Objective response rate assessed by Investigator

  Baseline up to approximately 12 months.

• Disease control rate

  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.

Study Arms (1)

treatment group

EXPERIMENTAL

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

Drug: AK104

Interventions

AK104 DRUG

AK104（10.0 mg/kg，intravenous (IV) infusion，Q3W）maintained with no more than 1 year.

Also known as: Cadonilimab Injection

treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Second University Hospital: lead
• Affiliated Hospital of North Sichuan Medical College: collaborator
• The Affiliated Hospital Of Southwest Medical University: collaborator

Study Sites (1)

West China Second University Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Rutie Yin, Clinical Professor

CONTACT

yrtt2013@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 9, 2024
• Study Start: February 20, 2024
• Primary Completion: May 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 9, 2024

Record last verified: 2024-02

Locations

CN (1)