Locally Advanced Cervical CancerPhase 2NCT05687851
Study Of Cadonilimab Combined With Radiotherapy In The Treatment of Locally Advanced Cervical Cancer
A Phase 2 study testing Cadonilimab（AK104）, EBRT and BT in people with Locally Advanced Cervical Cancer, run by Chongqing University Cancer Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Locally Advanced Cervical Cancer
- What is being tested?
- Cadonilimab（AK104）, EBRT and BT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 29 Dec 2022to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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)
Who cannot join
- 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 enter the study.
- Subject who cannot receive brachytherapy.
- Active or prior documented autoimmune disease that may relapse.
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- 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 enter the study.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chongqing university Cancer Hospital
Chongqing, CHN, 400000
Xingtao Long, MD, +86232365075619, longxingtao2009@163.com
Qi Zhou, PhD
About this study
Official title: A Single-arm, Multicenter, Phase II Study to Evaluate Cadonilimab（AK104） Combined With Radiotherapy For The Treatment of Locally Advanced Cervical Cancer
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.
- Conditions
- Locally Advanced Cervical Cancer
- Being tested
- Cadonilimab（AK104）, EBRT, BT
- Keywords
- Local advanced cervical cancer, Concurrent chemoradiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cadonilimab（AK104）Drug
q3w iv
EBRTRadiation
45-50.4Gy
BTRadiation
≥80Gy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Cadonilimab（AK104）; Radiation: EBRT; Radiation: BT |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR assessed by Investigator
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR per RECIST v1.1.
Measured: Up to 2 years
Secondary outcomes (5)
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.
Measured: Up to 2 years
PFS
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.
Measured: Up to approximately 30 months
OS
OS is the time from randomization to death due to any cause
Measured: 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.
Measured: 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.
Measured: Up to approximately 40 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start29 Dec 2022
- Primary completion30 Dec 2024 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing University Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Liaoning Cancer Hospital & Institute, Henan Cancer Hospital, Fujian Cancer Hospital
- Responsible party
- Principal investigator, Qi Zhou, Chongqing University Cancer Hospital
- Investigators
- Qi Zhou, MD, Principal investigator, Chongqing University Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05687851
- Sponsor's protocol ID
- CQGOG010
- Status last verified
- Sep 2024
- First submitted
- 24 Dec 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Multicenter, Phase II Study to Evaluate Cadonilimab（AK104） Combined With Radiotherapy For The Treatment of Locally Advanced Cervical Cancer
- ClinicalTrials.gov ID
- NCT05687851
- Acronym / sponsor ID
- CQGOG010
- Conditions
- Locally Advanced Cervical Cancer
- Keywords
- Local advanced cervical cancer, Concurrent chemoradiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Chongqing University Cancer HospitalUniversity, hospital or other
- Collaborators
- Liaoning Cancer Hospital & Institute, Henan Cancer Hospital, Fujian Cancer Hospital
- Study start
- 29 Dec 2022 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment arm | Experimental | Drug: Cadonilimab（AK104）, Radiation: EBRT, Radiation: BTParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (14 listed)
- 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 enter the study.
- Subject who cannot receive brachytherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cadonilimab（AK104）q3w iv | Drug | treatment arm |
| EBRT45-50.4Gy | Radiation | treatment arm |
| BT≥80Gy | Radiation | treatment arm |
Primary outcome
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.
5 secondary outcomes
DCR
Time frame: Up to 2 years
PFS
Time frame: Up to approximately 30 months
OS
Time frame: 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
Number of participants with adverse events (AEs)
Time frame: Up to approximately 40 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Qi Zhou, MD principal investigator
Chongqing University Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cadonilimab（AK104）, EBRT and BT in people with Locally Advanced Cervical Cancer, run by Chongqing University Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xingtao Long, MD (+8602365075619, longxingtao2009@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR assessed by Investigator (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.