Cadonilimab in the Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma

Phase 1

Not yet recruiting

• Conditions: Nasopharyngeal Carcinoma; Immune Checkpoint Inhibitors
• Interventions: Drug: Cadonilimab; Drug: Gemcitabine; Drug: Cisplatin

• Registration Number: NCT05898256
• Lead Sponsor: Guangxi Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-01
• Study First Submitted QC: 2023-06-01
• Last Update Submitted: 2023-06-01
• Study First Posted: 2023-06-12
• Last Update Posted: 2023-06-12
• Study Start: 2023-08-01
• Primary Completion: 2024-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bispecific Antibody + GP Group	Cadonilimab	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.
Bispecific Antibody + GP Group	Gemcitabine	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.
Bispecific Antibody + GP Group	Cisplatin	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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