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drugset / Trial / NCT07070479

Combination Therapy for PD-1 Resistant Recurrent or Metastatic Nasopharyngeal Carcinoma: A Bayesian Adaptive Phase II Trial

NCT07070479 ↗

Phase 2 Recruiting 208 enrolled Ming-Yuan Chen
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a prospective, Bayesian adaptive, phase II clinical trial designed to evaluate the safety and efficacy of four treatment regimens in patients with recurrent (unamenable to local therapy) or metastatic nasopharyngeal carcinoma (NPC) who have failed after at least one prior platinum-containing standard regimen and anti-PD-1/PD-L1 therapy. The four treatment arms include: 1. Ivonescimab monotherapy, 2. Ivonescimab combined with nimotuzumab, 3. Liposomal mitoxantrone plus anti-PD-1 antibody, and 4. Liposomal irinotecan plus S-1.

Timeline

Start
2025-06-24
Primary completion
2027-01-30
Completion
2028-01-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule 50 mg/m2 Intravenous
Subject Ivonescimab Monoclonal antibody 10 mg/kg Intravenous
Subject Mitoxantrone hydrochloride liposome Unknown 20 mg/m2 Intravenous
Subject Nimotuzumab Monoclonal antibody 400 mg Intravenous
Subject S-1 Small molecule 40 mg Oral
Subject S-1 Small molecule 50 mg Oral
Subject S-1 Small molecule 60 mg Oral
Subject Tislelizumab Monoclonal antibody 200 mg —
Subject Toripalimab Monoclonal antibody 240 mg —
Subject carrellimab Monoclonal antibody 200 mg —

Indications

nasopharyngeal carcinoma