drugset / Trial / NCT06241599
A Multi-center, Randomized, Double-blind, Phase II/III Clinical Trial of AK104 or Placebo in Combination With Chemotherapy as Second-line or More Lines for Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)
RandomizedParallel-groupTriple-blindTreatment
Summary
To compare whether AK104 combined with GP or PFLL can improve survival benefit, safety and tolerability in nasopharyngeal carcinoma patients who have failed first-line treatment; To compare the survival benefits of GP or GFLL treatment in nasopharyngeal carcinoma patients who had failed first-line therapy; To compare the survival benefits of GP or GFLL combined with AK104 in patients with nasopharyngeal carcinoma who had failed first-line therapy.
Timeline
- Start
- 2024-02-01
- Primary completion
- 2026-02-01
- Completion
- 2029-02-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cadonilimab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | — |
| Subject | fluorouracil | Small molecule | 200 mg/m2 | Intravenous |
| Background | Cisplatin | Other / unclassified | 80 mg/m2 | Intravenous |