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Trial Title:
Study Of Cadonilimab Combined With Radiotherapy In The Treatment of Locally Advanced Cervical Cancer
NCT ID:
NCT05687851
Condition:
Locally Advanced Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Conditions: Keywords:
Local advanced cervical cancer
Concurrent chemoradiotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Cadonilimab（AK104）
Description:
q3w iv
Arm group label:
treatment arm
Intervention type:
Radiation
Intervention name:
EBRT
Description:
45-50.4Gy
Arm group label:
treatment arm
Intervention type:
Radiation
Intervention name:
BT
Description:
≥80Gy
Arm group label:
treatment arm
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Able to understand and voluntarily sign written informed consent.
2. Women aged ≥18 years at the time of study entry.
3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-2.
4. Life expectancy ≥12 weeks.
5. Intolerance to chemotherapy regimens.
6. Histologically confirmed cervical cancer.
1. Histologically-confirmed squamous cell carcinoma, adenocarcinoma, or
adenosquamous carcinoma of the cervix;
2. Not receiving systemic anti-tumour therapy (including but not limited to
radiotherapy, targeted therapy and immunotherapy, etc; concurrent chemotherapy
is not included. Note: Removal or biopsy of pelvic lymph nodes or para-aortic
lymph nodes for the purpose of clinical staging is allowed).
3. Locally advanced cervical cancer（LACC）: The International Federation of
Gynecology and Obstetrics (FIGO) 2018 Stage IB3/IIA2, IIB-IVA.
7. At least one measurable tumor lesion according to RECIST v1.1 criteria.
8. Available archived tumor tissue samples or recent biopsies.
9. Adequate organ function.
10. 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:
1. Other histological types of cervical cancer (eg, neuroendocrine carcinoma, small
cell carcinoma, sarcoma, etc).
2. Evidence of distant metastases.
3. Have received total hysterectomy.
4. Subject with other active malignancies within 2 years prior enter the study.
5. Subject who cannot receive brachytherapy.
6. Active or prior documented autoimmune disease that may relapse.
7. History of interstitial lung disease or noninfectious pneumonitis.
8. Subject with the clinically significant cardio-cerebrovascular disease.
9. History of severe hypersensitivity reactions to other mAbs.
10. Prior allogeneic stem cell transplantation or organ transplantation.
11. Subjects who require systemic treatment with glucocorticoid (>10 mg/day of
prednisone or equivalent glucocorticoid) or other immunosuppressive agents within 14
days prior enter the study.
12. Receipt of live attenuated vaccines within 30 days prior to the first dose of the
study drug.
13. Prior exposure to any experimental antitumor vaccines, or any agent targeting T-cell
costimulation or immune checkpoint pathways (eg, anti-PD-1, anti-PD-L1, anti-PD-L2,
anti-CTLA-4, anti-CD137 or anti-OX40 antibody, etc).
14. Any condition that, in the opinion of the Investigator, would interfere with the
evaluation of the study drug or interpretation of subject safety or study results.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Chongqing university Cancer Hospital
Address:
City:
Chongqing
Zip:
400000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xingtao Long, MD
Phone:
+86232365075619
Email:
longxingtao2009@163.com
Investigator:
Last name:
Qi Zhou, PhD
Email:
Principal Investigator
Start date:
December 29, 2022
Completion date:
December 2026
Lead sponsor:
Agency:
Chongqing University Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Liaoning Tumor Hospital & Institute
Agency class:
Other
Collaborator:
Agency:
Henan Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Fujian Cancer Hospital
Agency class:
Other
Source:
Chongqing University Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05687851
