Cadonilimab (AK104) in the Treatment of Nasopharyngeal Carcinoma

NCT05790200 | Unknown Phase 2

• 1 other identifier: AK104-IIT
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (3)

• Adverse Event(AE)

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

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

• 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

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

• 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

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

Secondary Outcomes (1)

• Overall Survival,OS

  3 years

Other Outcomes (1)

• Time to progress，TTP

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

Study Arms (1)

Cadonilimab (AK104) combined with chemotherapy

EXPERIMENTAL

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

Drug: Cadonilimab

Interventions

Cadonilimab DRUG

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.

Also known as: AK104

Cadonilimab (AK104) combined with chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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 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.

Sponsors & Collaborators

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

Study Sites (1)

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

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Yang Kunyu, Doctor

CONTACT

13995595360; yangkunyu@hust.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 30, 2023
• Study Start: April 1, 2023
• Primary Completion: September 22, 2025
• Study Completion: September 22, 2025
• Last Updated: March 30, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)