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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

NCT07546383 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-04-22

No results posted yet for this study

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.

Conditions

  • Squamous Cell Carcinoma of Head and Neck

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.

Sponsors & Collaborators

  • The Second Affiliated Hospital of Hainan Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-13
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07546383 on ClinicalTrials.gov