Cadonilimab in the Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05898256
• Other study ID #: GuangxiMUHK4
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: August 1, 2023
• Est. completion date: July 31, 2026

Study information

• Verified date: June 2023
• Source: Guangxi Medical University
• Contact: kai hu, professor
• Phone: +867715356509
• Email: gxhukai[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: July 31, 2026
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Immune Checkpoint Inhibitors
• Nasopharyngeal Carcinoma

Intervention

Drug:
• Cadonilimab
10mg/kg administered intravenously (IV)
• Gemcitabine
1 g/m2, administered as an IV infusion within 30 minutes
• Cisplatin
80 mg/m2, administered as an IV infusion over 4 hours

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guangxi Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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