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RECRUITING
NCT07546383
NA

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

Sponsor: The Second Affiliated Hospital of Hainan Medical University

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2026-04-13

Completion Date

2028-12-31

Last Updated

2026-04-22

Healthy Volunteers

No

Interventions

DRUG

Iparomlimab and tuvonralimab

Patients are assigned to either combination antibody monotherapy or combination antibody plus chemotherapy based on PD-L1 CPS, symptom burden, disease characteristics, and patient preference. Monotherapy arm: Iparomlimab and tuvonralimab combination antibody 5 mg/kg intravenously on day 1 of each 21-day cycle, repeated until disease progression, unacceptable toxicity, withdrawal of consent, or other discontinuation criteria. Combination arm: The same antibody regimen (5 mg/kg on day 1, every 3 weeks) plus chemotherapy for up to 6 cycles. Chemotherapy consists of: Platinum (carboplatin AUC 5 or cisplatin 75 mg/m²) on day 1, and Either docetaxel 75 mg/m² or paclitaxel 135-175 mg/m² on day 1. After completion of 6 chemotherapy cycles, patients continue on antibody monotherapy alone (same dose and schedule) as maintenance until disease progression or other discontinuation criteria.

Locations (1)

The Second Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China