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Iparomlimab and Tuvonralimab +/- Chemotherapy in R/M HNSCC
NCT07546383Phase 2
Key facts
- Status
- Recruiting
- Start
- Apr 2026
- Primary completion
- Dec 2027
- Countries
- 1
- Sponsor
- Second Affiliated Hospital of Hainan Medical University
- Modality
- Immune Checkpoint Inhibitors
- Conditions
- head and neck squamous cell carcinoma (HNSCC)
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Overview
Phase 2, open-label, single-arm trial of iparomlimab and tuvonralimab in head and neck squamous cell carcinoma (HNSCC), sponsored by Second Affiliated Hospital of Hainan Medical University. Primary endpoint: Objective Response Rate. Started Apr 2026; status: recruiting.
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Design
1 arm- Study design
- Non-randomizedOpen-label
single-arm
Patients receive Iparomlimab and tuvonralimab with or without up to 6 cycles of platinum plus docetaxel or paclitaxel, followed by antibody monotherapy maintenance.
03
Who it enrols
Adults aged 18-75 with recurrent or metastatic head and neck squamous cell carcinoma who have progressed after at least one line of systemic therapy, with an ECOG score of 0-2 and adequate organ function.
04
Endpoints
Primary
Objective Response Rate
Secondary
Disease Control Rate
6-month Progression-Free Survival rate
6-month Overall Survival rate
Incidence of adverse events
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