Clinical trial · Interventional
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
NCT05898256CI-TRIAL-00067064unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Immune Checkpoint Inhibitors | — | UNRESOLVED | — |
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cadonilimab | Drug | — | UNRESOLVED |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bispecific Antibody + GP Group
- 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.
- interventionNames
- Drug: Cadonilimab
- Drug: Gemcitabine
- Drug: Cisplatin
Primary outcomes (2)
- measure
- Objective response rate(ORR)
- timeFrame
- Up to approximately 2 years
- description
- ORR is proportion of patients with complete response(CR) or partial response(PR) assessed by investigators according to RECIST v1.1.
- measure
- Incidence and severity of adverse events(AEs)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.