Cadonilimab in the Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma

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Primary Purpose

Status

Not yet recruiting

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Cadonilimab

Gemcitabine

Cisplatin

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bispecific Antibody + GP Group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Incidence and severity of adverse events(AEs)

Incidence and severity of AEs is aim to evaluate the safety of Cadonilimab in combination with chemotherapy.

Secondary Outcome Measures

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.

Overall Survival (OS)

Overall survival (OS) is defined as the time from the first dose of Cadonilimab until death due to any cause.

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.

Full Information

NCT ID

NCT05898256

First Posted

June 1, 2023

Last Updated

June 1, 2023

Sponsor

Guangxi Medical University

1. Study Identification

Unique Protocol Identification Number

NCT05898256

Brief Title

Cadonilimab in the Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

August 1, 2023 (Anticipated)

Primary Completion Date

July 31, 2024 (Anticipated)

Study Completion Date

July 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guangxi Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasopharyngeal Carcinoma, Immune Checkpoint Inhibitors

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Bispecific Antibody + GP Group

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Cadonilimab

Other Intervention Name(s)

AK104

Intervention Description

10mg/kg administered intravenously (IV)

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

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

Primary Outcome Measure Information:

Title

Objective response rate(ORR)

Description

ORR is proportion of patients with complete response(CR) or partial response(PR) assessed by investigators according to RECIST v1.1.

Time Frame

Up to approximately 2 years

Title

Incidence and severity of adverse events(AEs)

Description

Incidence and severity of AEs is aim to evaluate the safety of Cadonilimab in combination with chemotherapy.

Time Frame

Up to approximately 2 years

Secondary Outcome Measure Information:

Title

Progression-free survival (PFS)

Description

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.

Time Frame

Up to approximately 2 years

Title

Overall Survival (OS)

Description

Overall survival (OS) is defined as the time from the first dose of Cadonilimab until death due to any cause.

Time Frame

Up to approximately 2 years

Title

Disease control rate (DCR)

Description

DCR is proportion of patients with complete response, partial response or stable disease assessed by investigators according to RECIST v1.1.

Time Frame

Up to approximately 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

kai hu, professor

Phone

+867715356509

Email

gxhukai@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD

No

Nasopharyngeal Carcinoma, Immune Checkpoint Inhibitors

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial