Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Participants receive candonilimab at a dose of 10 mg/kg, Q3W (Day 1 of each 21 day treatment cycle) via IV infusion, until disease progression, intolerable toxicity, investigator determines that the participant cannot continue to benefit, withdraws informed consent, or candonilimab treatment over 2 years. During the q3w dosing period of candonilimab, participants receive radiotherapy including external beam radiotherapy (EBRT) and followed by brachytherapy.

Candonilimab（AK104）

EBRT

Xingtao Long, MD

Qi Zhou, PhD

Qi Zhou, MD

Candonilimab（AK104）is a humanized IgG1 bispecific antibody that targets PD-1 and CTLA-4.

This is a single-arm, multicenter, open-label, phase II study, the purpose of this study is to evaluate the efficacy and safety of candonilimab plus radiotherapy in participants with locally advanced cervical cancer who do not tolerate chemotherapy.

Study Of Candonilimab Combined With Radiotherapy In The Treatment of Locally Advanced Cervical Cancer

A Single-arm, Multicenter, Phase II Study to Evaluate Candonilimab（AK104） Combined With Radiotherapy For The Treatment of Locally Advanced Cervical Cancer

The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR per RECIST v1.1.

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.

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.

OS is the time from randomization to death due to any cause

The EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Global scores are converted to a score of 0 to 100, with a higher score indicating improved health status. The change from baseline in EORTC QLQ-C30 score will be presented.

An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study Of Candonilimab Combined With Radiotherapy In The Treatment of Locally Advanced Cervical Cancer	NCT05687851	Locally Advance...	Candonilimab（AK... EBRT BT	18 Years -	Chongqing University Cancer Hospital
Study Of Candonilimab Combined With Radiotherapy In The Treatment of Locally Advanced Cervical Cancer	NCT05687851	Locally Advance...	Candonilimab（AK... EBRT BT	18 Years -	Chongqing University Cancer Hospital

Spots Global Cancer Trial Database for bt

Every month we try and update this database with for bt cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for bt

Every month we try and update this database with for bt cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for bt cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.