Iparomlimab Tuvonralimab Head Neck Cancer Phase II Trial
Summary
This single-arm, open-label Phase II study (NCT07546383) evaluates 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 at least one prior systemic therapy. The trial includes a safety run-in phase of approximately three patients, followed by assignment to monotherapy (both antibodies at 5 mg/kg on Day 1, every 3 weeks) or combination therapy adding up to six cycles of platinum-based chemotherapy. The primary endpoint is objective response rate per RECIST 1.1, with secondary endpoints including disease control rate, 6-month progression-free survival, 6-month overall survival, and safety profile.
“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.”
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What changed
A Phase II clinical trial (NCT07546383) has been registered, investigating the combination of two antibodies—iparomlimab and tuvonralimab—in patients with recurrent or metastatic head and neck squamous cell carcinoma who have progressed after prior systemic therapy. The study follows a safety run-in design with monotherapy and combination arms stratified by PD-L1 combined positive score, symptom burden, disease characteristics, and patient preference.
For sponsors and clinical investigators in oncology drug development, this trial represents a novel bispecific checkpoint combination approach. The exploratory biomarker objectives (PD-L1 expression and tumor mutation burden) may inform future patient-selection strategies for similar immunotherapy combinations in HNSCC.
Archived snapshot
Apr 22, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
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
N/A NCT07546383 Kind: NA Apr 22, 2026
Abstract
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.
Conditions: Squamous Cell Carcinoma of Head and Neck
Interventions: Iparomlimab and tuvonralimab
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