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Trial Title:
Cadonilimab in the Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma
NCT ID:
NCT05898256
Condition:
Nasopharyngeal Carcinoma
Immune Checkpoint Inhibitors
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Gemcitabine
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet 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
Description:
10mg/kg administered intravenously (IV)
Arm group label:
Bispecific Antibody + GP Group
Other name:
AK104
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
1 g/m2, administered as an IV infusion within 30 minutes
Arm group label:
Bispecific Antibody + GP Group
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
80 mg/m2, administered as an IV infusion over 4 hours
Arm group label:
Bispecific Antibody + GP Group
Summary:
This study is a single-arm, multicenter clinical study to evaluate the efficacy and
safety of Cadonilimab in combination with gemcitabine/cisplatin as a first-line treatment
for recurrent or metastatic nasopharyngeal carcinoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. The subject must sign the written informed consent form (ICF) voluntarily；
2. Age ≥18 years and ≤65 years；
3. Subjects with histopathological diagnosis of nasopharyngeal carcinoma；
4. Primarily metastatic (stage IVB as defined by AJCC staging system for NPC, eighth
edition) or recurrent/metastatic NPC that is not amenable to local regional
treatment or curative treatment and at least 6 months after radical treatment；
5. Has not received prior systemic treatment;
6. Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)
Performance Status
7. Subject must have a measurable target lesion based on RECIST v1.1;
Exclusion Criteria:
1. Allergic to monoclonal antibodies, any cadonilimab components, gemcitabine,
cisplatin, and other platinum drugs;
2. Prior therapy as follow:
Anti-PD-1, anti-PD-L1 or anti-CTLA-4; Concurrent medical condition requiring the use
of cortisol (>10mg/day Prednisone or equivalent dose) or other systematic
immunosuppressive medications within 14 days before the study
treatment（Except：inhalation or topical corticosteroids）.
3. Any active malignancy ≤ 2 years before randomization except for specific cancer
under investigation in this study and any locally recurring cancer that has been
treated curatively (eg, resected basal or squamous cell skin cancer, superficial
bladder cancer, carcinoma in situ of the cervix or breast)；
4. Female patients who are at pregnancy or lactation.
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Start date:
August 1, 2023
Completion date:
July 31, 2026
Lead sponsor:
Agency:
Guangxi Medical University
Agency class:
Other
Source:
Guangxi Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05898256
