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Cadonilimab in the Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma

ConditionsNasopharyngeal CarcinomaImmune Checkpoint Inhibitors
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGuangxi Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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；

Disqualifiers

Allergic to monoclonal antibodies, any cadonilimab components, gemcitabine, cisplatin, and other platinum drugs;

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Cadonilimab

    Drug

    10mg/kg administered intravenously (IV)

  • Gemcitabine

    Drug

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

  • Cisplatin

    Drug

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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Bispecific Antibody + GP GroupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to approximately 2 years
2

Incidence and severity of adverse events(AEs)

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 outcomes

1

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.

Time frame
Up to approximately 2 years
2

Overall Survival (OS)

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
3

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.

Time frame
Up to approximately 2 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangxi Medical University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: