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Ivonescimab combinations in PD-1-resistant NPC
NCT07070479Phase 2
Key facts
- Status
- Recruiting
- Start
- Jun 2025
- Primary completion
- Jan 2027
- Countries
- 1
- Modality
- Antibody Conjugates, Bispecific Antibodies, Monoclonal Antibodies
- Drugs
- ivonescimab
- Conditions
- nasopharyngeal carcinoma (NPC)
01
Overview
Phase 2, randomised, open-label trial of ivonescimab in nasopharyngeal carcinoma (NPC) (4 arms). Primary endpoint: Overall Response Rate at 1 year. Started Jun 2025; status: recruiting.
02
Design
4 arms- Study design
- RandomizedOpen-label
Ivonescimab Monotherapy
Ivonescimab 10 mg/kg Q3W
Ivonescimab + Nimotuzumab
Ivonescimab 10 mg/kg + Nimotuzumab 400 mg Q3W
Mitoxantrone + PD-1
Liposomal Mitoxantrone 20 mg/m2 + PD-1 Inhibitor Q3W
Irinotecan + S-1
Liposomal Irinotecan 50 mg/m2 Q4W + S-1 BID D1-14
03
Who it enrols
Patients with recurrent or metastatic non-keratinizing NPC who have progressed on platinum-based chemotherapy and anti-PD-1 therapy, with no prior VEGF-targeting treatment.
04
Endpoints
Primary
Overall Response Rate
Secondary
Progression-free Survival
Overall Survival
Duration of Response
Disease Control Rate
Adverse Events Reporting
Health-related Quality of Life
Head and Neck Cancer-Specific Quality of Life
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