- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05687851
Study Of Candonilimab Combined With Radiotherapy In The Treatment of Locally Advanced Cervical Cancer
January 15, 2023 updated by: Qi Zhou, Chongqing University Cancer Hospital
A Single-arm, Multicenter, Phase II Study to Evaluate Candonilimab(AK104) Combined With Radiotherapy For The Treatment of Locally Advanced Cervical Cancer
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 Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
33
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xingtao Long, MD
- Phone Number: +8602365075619
- Email: longxingtao2009@163.com
Study Locations
-
-
CHN
-
Chongqing, CHN, China, 400000
- Recruiting
- Chongqing University Cancer Hospital
-
Contact:
- Xingtao Long, MD
- Phone Number: +86232365075619
- Email: longxingtao2009@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Able to understand and voluntarily sign written informed consent.
- Women aged ≥18 years at the time of study entry.
- Eastern Cancer Cooperative performance status (ECOG PS) score of 0 or 1.
- Life expectancy ≥12 weeks.
- Participants' intolerance to chemotherapy regimens.
Histologically confirmed cervical cancer.
- Histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix;
- 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).
- Locally advanced cervical cancer(LACC): The International Federation of Gynecology and Obstetrics (FIGO) 2018 Stage IB3/IIA2, IIB-IVA.
- 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:
- Other histological types of cervical cancer (eg, neuroendocrine carcinoma, small cell carcinoma, sarcoma, etc).
- Evidence of distant metastases.
- Have received total hysterectomy.
- Subject with other active malignancies within 2 years prior to randomization.
- Subject who cannot receive brachytherapy.
- Active or prior documented autoimmune disease that may relapse.
- History of interstitial lung disease or noninfectious pneumonitis.
- Subject with the clinically significant cardio-cerebrovascular disease.
- History of severe hypersensitivity reactions to other mAbs.
- Prior allogeneic stem cell transplantation or organ transplantation.
- Subjects who require systemic treatment with glucocorticoid (>10 mg/day of prednisone or equivalent glucocorticoid) or other immunosuppressive agents within 14 days prior to randomization.
- Receipt of live attenuated vaccines within 30 days prior to the first dose of the study drug.
- 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).
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: treatment arm
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.
|
q3w iv
45-50.4Gy
≥80Gy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ORR assessed by Investigator
Time Frame: Up to 2 years
|
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR per RECIST v1.1.
|
Up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
DCR
Time Frame: Up to 2 years
|
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
Time Frame: Up to approximately 30 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.
|
Up to approximately 30 months
|
OS
Time Frame: Up to approximately 40 months
|
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.
Time Frame: Baseline and up to approximately 40 months
|
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)
Time Frame: Up to approximately 40 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: QI ZHOU, MD, Chongqing University Cancer Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 29, 2022
Primary Completion (Anticipated)
June 1, 2024
Study Completion (Anticipated)
December 1, 2026
Study Registration Dates
First Submitted
December 24, 2022
First Submitted That Met QC Criteria
January 15, 2023
First Posted (Actual)
January 18, 2023
Study Record Updates
Last Update Posted (Actual)
January 18, 2023
Last Update Submitted That Met QC Criteria
January 15, 2023
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CQGOG010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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