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)

NCT06241599

Phase 2/3 Recruiting 300 enrolled Sun Yat-sen University
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

EvaluationDrugModalityDoseRoute
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