Cadonilimab in the Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma

Study Overview
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Brief Summary
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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.

Official Title
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A Single-arm, Multicenter, Phase II Study Evaluating the Efficacy and Safety of Cadonilimab Plus Chemotherapy for Recurrent or Metastatic Nasopharyngeal Carcinoma

Conditions
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Nasopharyngeal Carcinoma, Immune Checkpoint Inhibitors

Intervention / Treatment
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* Drug: Cadonilimab
* Drug: Gemcitabine
* Drug: Cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject must sign the written informed consent form (ICF) voluntarily； Age ≥18 years and ≤65 years； Subjects with histopathological diagnosis of nasopharyngeal carcinoma； 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； Has not received prior systemic treatment; Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status Subject must have a measurable target lesion based on RECIST v1.1; Exclusion Criteria: Allergic to monoclonal antibodies, any cadonilimab components, gemcitabine, cisplatin, and other platinum drugs; 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）. 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)； Female patients who are at pregnancy or lactation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bispecific Antibody + GP Group<br>Cadonilimab will be administered once every 3 weeks (Q3W), for up to 2 years； Gemcitabine on Day 1, Day 8 of each 3 weeks cycle, for 4 to 6 cycles； Cisplatin on Day 1 of each 3 weeks cycle, for 4 to 6 cycles. | Drug: Cadonilimab<br>* 10mg/kg administered intravenously (IV)<br>* Other names: AK104;Drug: Gemcitabine<br>* 1 g/m2, administered as an IV infusion within 30 minutes<br>Drug: Cisplatin<br>* 80 mg/m2, administered as an IV infusion over 4 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate(ORR) | ORR is proportion of patients with complete response(CR) or partial response(PR) assessed by investigators according to RECIST v1.1. | Up to approximately 2 years | 
| Incidence and severity of adverse events(AEs) | Incidence and severity of AEs is aim to evaluate the safety of Cadonilimab in combination with chemotherapy. | Up to approximately 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) | Progression-free survival (PFS) is defined as the time from the first dose of Cadonilimab until documentation of PD (as per RECIST v1.1) or death due to any cause, whichever occurs first. | Up to approximately 2 years | 
| Overall Survival (OS) | Overall survival (OS) is defined as the time from the first dose of Cadonilimab until death due to any cause. | Up to approximately 2 years | 
| Disease control rate (DCR) | DCR is proportion of patients with complete response, partial response or stable disease assessed by investigators according to RECIST v1.1. | Up to approximately 2 years |