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Nasopharyngeal CarcinomaPhase 2NCT05790200

Cadonilimab (AK104) in the Treatment of Nasopharyngeal Carcinoma

A Phase 2 study testing Cadonilimab in people with Nasopharyngeal Carcinoma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is a phase II clinical study of Cadonilimab (AK104) combined with chemotherapy in the treatment of PD-1 inhibitor-resistant nasopharyngeal carcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Nasopharyngeal Carcinoma
What is being tested?
Cadonilimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
1 Apr 2023to 22 Sep 2025
Phase
Phase 2
Are there results?
None posted in the registry

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The age at the time of enrollment is more than 18 years old and less than 75 years old, both male and female.
  • The Eastern Cancer Cooperation Organization (ECOG) physical fitness score was 0 or 1.
  • The expected survival period is more than 3 months.
  • Nasopharyngeal carcinoma confirmed by histology or cytology.
  • The subject has previously received treatment with PD-1 inhibitor and failed without indication of radical local treatment.
  • According to the evaluation standard of curative effect of solid tumor, RECIST v l L At least one measurable lesion.

Who cannot join

  • Except for nasopharyngeal carcinoma, the subjects had other malignant tumors within 2 years before enrollment. Subjects with other tumors that have been cured by local treatment, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervical or breast cancer in situ, are not excluded.
  • He participated in the treatment of experimental drugs within 4 weeks before the first study administration.
  • Patients with active autoimmune diseases that require systematic treatment in the past two years (such as the use of disease improvement drugs, corticosteroids, immunosuppressive therapy), and replacement therapy (such as thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) are not considered as a systemic treatment.
  • Have a history of immune deficiency; HIV antibody test positive; At present, systemic corticosteroids or other immunosuppressants are being used for a long time.
  • Active tuberculosis (TB) is known. Subjects suspected of active TB should be excluded from active TB.
  • The history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation are known.
Show all 19Show fewer
  • The untreated active hepatitis B subjects (HBsAg positive and HBV-DNA more than 1000 copies/ml (200 IU/ml) or higher than the lower detection limit, whichever is higher) are required to receive anti hepatitis B virus treatment during the study treatment period; Active hepatitis C subjects (HCV antibody positive and HCV-RNA level higher than the lower limit of detection).
  • Major surgical operation or serious injury occurred within 30 days before the first administration, or major surgical operation planner (determined by the researcher) within 30 days after the first administration; Minor local operations (excluding central venous catheterization via peripheral vein puncture) were performed within 3 days before the first administration.
  • There is central nervous system metastasis.
  • There are currently uncontrolled concomitant diseases, including but not limited to symptomatic congestive heart failure (grade 2 and above determined according to the functional classification of the New York Heart Association), unstable angina pectoris, acute myocardial ischemia, poorly controlled arrhythmia, decompensated liver cirrhosis, nephrotic syndrome, uncontrolled metabolic disorder, severe active peptic ulcer disease or gastritis, Mental illness/social condition that may limit the subject's compliance with the research requirements or affect the subject's ability to provide written informed consent.
  • There was a history of myocarditis, cardiomyopathy and malignant arrhythmia in the past. Unstable angina pectoris, congestive heart failure or vascular disease (such as aortic aneurysm or peripheral venous thrombosis requiring surgical repair) that needs hospitalization within 12 months before the first administration of the drug, or other cardiac damage that may affect the safety evaluation of the study drug (such as poorly controlled arrhythmia, myocardial infarction or ischemia); There is a history of esophageal and gastric varices, serious ulcer, wound healing, gastrointestinal perforation, abdominal pain, gastrointestinal obstruction, abdominal abscess or acute gastrointestinal bleeding within 6 months before the first administration; Any arterial thromboembolic event occurred within 6 months before the first administration, including venous thromboembolic generation of NC I CTCAE 5.0 grade 3 and above, transient ischemic attack, cerebrovascular accident, hypertensive crisis or hypertensive encephalopathy; Acute exacerbation of chronic obstructive pulmonary disease occurred within 1 month before the first administration; There is currently hypertension and after treatment with oral antihypertensive drugs, the systolic blood pressure is more than 160 mmHg or the diastolic blood pressure is less than 100 mmHg.
  • Have a history of severe bleeding tendency or coagulation dysfunction; One month before the first administration, there were blood symptoms with significant clinical significance, including but not limited to gastrointestinal bleeding, hemoptysis, screening imaging showed that the tumor wrapped around important blood vessels or had obvious necrosis and cavity, and the researcher believed that participating in the study might cause bleeding risk;
  • The toxicity of previous anti-tumor treatment has not been relieved, which is defined as that the toxicity has not returned to the level 0 or 1 of NC l CTCAE 5.0, or the level specified in the inclusion/exclusion criteria, except for the sequelae of hair loss and previous lead treatment related neurotoxicity. Subjects (such as hearing loss) who have irreversible toxicity and are not expected to worsen after administration of the study drug may be included in the study after consultation with the medical examiner. Subjects with long-term toxicity caused by radiotherapy that cannot be recovered according to the judgment of the researcher may be included in the study after consultation with the medical supervisor.
  • The live vaccine was vaccinated within 30 days before the first administration, or was planned to be vaccinated during the study period.
  • Known allergy to any component of any study drug; A history of severe hypersensitivity to other monoclonal antibodies is known.
  • Known history of mental illness, drug abuse, alcohol or drug abuse.
  • Pregnant or lactating women.
  • Any previous or current disease, treatment, or laboratory test abnormality may confuse the results of the study, affect the full participation of the subject in the study, or participation in the study may not be in the best interests of the subject.
  • Local or systemic diseases caused by non-malignant tumors, or diseases or symptoms secondary to tumors, which can lead to higher medical risk and/or uncertainty of survival evaluation, such as tumor-like leukemia reaction (white blood cell count>20 X 109/L or cachexia performance (such as known weight loss of more than 10% in the 3 months before screening), etc

Trial locations and contacts

1 site in 1 country.

Yang Kunyu, Doctor contact

13995595360

yangkunyu@hust.edu.cn

China1 site, 1 recruiting

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430000

    Yang Kunyu, doctor, 13995595360, yangkunyu@hust.edu.cn

    Recruiting

Other trials in China

About this study

Official title: A Phase II Clinical Study of Cadonilimab (AK104) Combined With Chemotherapy in the Treatment of PD-1 Inhibitor Resistant Nasopharyngeal Carcinoma

This study is a phase II clinical study of Cadonilimab (AK104) combined with chemotherapy in the treatment of PD-1 inhibitor-resistant nasopharyngeal carcinoma.

Read the detailed description

The purpose is to evaluate the safety and effectiveness of Cadonilimab combined with chemotherapy in the treatment of PD-1 inhibitor-resistant nasopharyngeal carcinoma as the second line and above. This study is a single-arm, phase II clinical study. It is planned to enroll about 30 patients with PD-1 inhibitor resistant nasopharyngeal carcinoma. PD-Ll CPS (<50% vs>50%, subjects whose PD-Ll expression could not be evaluated were classified as<50%) was used as the stratification factor. The study will set up a safety induction period. It is planned to enroll about 6 PD-1 inhibitor resistant subjects first, and the researchers will conduct a preliminary safety assessment. If the safety and tolerability are good, and the preliminary curative effect signal is observed, it will enter the extended group period. When about 15 subjects are selected, effectiveness analysis will be carried out. If 6 of the 15 subjects with severe side effects can not tolerate, the researcher may stop the group of subjects after discussion. In case of poor safety, the researcher decided to revise or stop the study after discussion.

Being tested
Cadonilimab
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CadonilimabDrug

    Also called AK104

    Cadonilimab (200 mg, administered on the first day of each cycle, Q3W, until there is no clinical benefit)+platinum-based chemotherapy, Q3W, 4-6 cycles), every 3 weeks (21 days) is a treatment cycle.

Study groups in NCT05790200
Study groupRoleWhat they receive
Cadonilimab (AK104) combined with chemotherapyExperimentalCadonilimab (200 mg, administered on the first day of each cycle, Q3W, until there is no clinical benefit)+platinum-based chemotherapy, Q3W, 4-6 cycles), every 3 weeks (21 days) is a treatment cycle
Receives: Drug: Cadonilimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Event(AE)

    The type, frequency, severity, timing, seriousness, and relationship to study therapyclinical significance

    Measured: From randomization to the end of the study，the evaluation lasts for 24 months

  2. Objective Response Rate，ORR

    The proportion of patients whose tumor volume is reduced to 30% and can be maintained for more than 4 weeks,Based on RECIST v i I Assessed ORR

    Measured: The last subject completes at least 24 weeks of follow-up (or disease progression)

  3. Progression-free survival，PFS

    The time from the beginning of the patient's treatment to the disease progression or death for any reason.Based on RECIST v i I Assessed PFS

    Measured: The last subject completes at least 24 weeks of follow-up (or disease progression)

Secondary outcomes (1)

  1. Overall Survival,OS

    The time from the patient receiving treatment to the death of the patient for any reason,OS evaluated according to RECIST vi. I

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2023
  2. Study start1 Apr 2023 (estimated)
  3. Primary completion22 Sep 2025 (estimated)
  4. Study completion22 Sep 2025 (estimated)

Resources

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
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05790200
Sponsor's protocol ID
AK104-IIT
Status last verified
Mar 2023
First submitted
1 Mar 2023
Last updated
30 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cadonilimab in people with Nasopharyngeal Carcinoma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 6 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 30 Mar 2023. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yang Kunyu, Doctor (13995595360, yangkunyu@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Event(AE) (time frame: From randomization to the end of the study，the evaluation lasts for 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05790200.

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 30 Mar 2023.

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