Cadonilimab in the Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma

NCT05898256 | Not Yet Recruiting Phase 1

• 1 other identifier: GuangxiMUHK4
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Nasopharyngeal Carcinoma; Immune Checkpoint Inhibitors

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Progression-free survival (PFS)

  Up to approximately 2 years

• Overall Survival (OS)

  Up to approximately 2 years

• Disease control rate (DCR)

  Up to approximately 2 years

Study Arms (1)

Bispecific Antibody + GP Group

EXPERIMENTAL

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; Drug: Gemcitabine; Drug: Cisplatin

Interventions

Cadonilimab DRUG

10mg/kg administered intravenously (IV)

Also known as: AK104

Bispecific Antibody + GP Group

Gemcitabine DRUG

1 g/m2, administered as an IV infusion within 30 minutes

Bispecific Antibody + GP Group

Cisplatin DRUG

80 mg/m2, administered as an IV infusion over 4 hours

Bispecific Antibody + GP Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangxi Medical University: lead

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

kai hu, professor

CONTACT

+867715356509; gxhukai@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: June 12, 2023
• Study Start: August 1, 2023
• Primary Completion: July 31, 2024
• Study Completion (Estimated): July 31, 2026
• Last Updated: June 12, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share