Cadonilimab in the Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Nasopharyngeal Carcinoma; Immune Checkpoint Inhibitors
• Intervention / Treatment: Drug: Cisplatin; Drug: Cadonilimab; Drug: Gemcitabine

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: kai hu, professor; Phone Number: +867715356509; Email: gxhukai@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bispecific Antibody + GP Group; 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: Cisplatin; 80 mg/m2, administered as an IV infusion over 4 hours; Drug: Cadonilimab; 10mg/kg administered intravenously (IV); Other Names: AK104; Drug: Gemcitabine; 1 g/m2, administered as an IV infusion within 30 minutes

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Guangxi Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: June 1, 2023
• First Submitted That Met QC Criteria: June 1, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Actual): June 12, 2023
• Last Update Submitted That Met QC Criteria: June 1, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Gemcitabine
• Other Study ID Numbers: GuangxiMUHK4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No