Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Liaoning Cancer Hospital & Institute | OTHER |
| Henan Cancer Hospital | OTHER_GOV |
| Fujian Cancer Hospital | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Cadonilimab(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 Cadonilimab plus radiotherapy in participants with locally advanced cervical cancer who do not tolerate chemotherapy.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment arm | Experimental | Participants receive Cadonilimab 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, withdraw informed consent, or Cadonilimab treatment over 2 years. During the q3w dosing period of Cadonilimab, participants receive radiotherapy including external beam radiotherapy (EBRT) and followed by brachytherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cadonilimab(AK104) | Drug | q3w iv |
| |
| EBRT |
| Measure | Description | Time Frame |
|---|---|---|
| ORR assessed by Investigator | The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR per RECIST v1.1. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| DCR | 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. | Up to 2 years |
| PFS |
Not provided
Inclusion Criteria:
Able to understand and voluntarily sign written informed consent.
Women aged ≥18 years at the time of study entry.
Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-2.
Life expectancy ≥12 weeks.
Intolerance to chemotherapy regimens.
Histologically confirmed cervical cancer.
At least one measurable tumor lesion according to RECIST v1.1 criteria.
Available archived tumor tissue samples or recent biopsies.
Adequate organ function.
For fertile women with negative serum pregnancy and effective contraception within 7 days before administration (until 120 days after the last administration of the study drug and at least 180 days after radiotherapy)
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xingtao Long, MD | Contact | +8602365075619 | longxingtao2009@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Qi Zhou, MD | Chongqing University Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chongqing university Cancer Hospital | Recruiting | Chongqing | CHN | 400000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Radiation |
45-50.4Gy |
|
| BT | Radiation | ≥80Gy |
|
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.
| Up to approximately 30 months |
| OS | OS is the time from randomization to death due to any cause | Up to approximately 40 months |
| Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status Score and Physical Function Score. | 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. | Baseline and up to approximately 40 months |
| Number of participants with adverse events (AEs) | 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. | Up to approximately 40 months |