What this Trial Is About

This is a single-arm, open-label, phase II study to evaluate the efficacy and safety of the combination of the antibodies iparomlimab and tuvonralimab, administered with or without chemotherapy, in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) who have progressed after receiving at least one line of systemic therapy. The study includes a safety run-in phase with approximately three patients, which may be expanded to six if a dose-limiting toxicity is observed. Patients are then assigned to either combination antibody monotherapy or combination antibody plus chemotherapy, based on PD-L1 combined positive score (CPS), symptom burden, disease characteristics and patient preference. Monotherapy involves iparomlimab and tuvonralimab (5 mg/kg on day 1, every 3 weeks). Combination therapy involves the same antibody regimen plus up to six cycles of platinum (carboplatin at an area under the curve (AUC) of 5 or cisplatin at 75 mg/m²) plus docetaxel (75 mg/m²) or paclitaxel (135-175 mg/m²), followed by antibody monotherapy maintenance. The primary objective is to assess the objective response rate (ORR) according to RECIST 1.1. The secondary objectives are to evaluate the disease control rate (DCR), the 6-month progression-free survival (PFS) rate, the 6-month overall survival (OS) rate and the safety profile. Exploratory objectives include the association of tumour biomarkers (PD-L1 expression and tumour mutation burden) with efficacy.

A Study Investigating the Efficacy and Safety of the Combination of Iparomlimab and Tuvonralimab With or Without Chemotherapy in Second-line and Subsequent Treatments for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma