A randomized, open-label, multicenter, Phase 3 trial of ivonescimab alone or ivonescimab with ligufalimab versus pembrolizumab for the first-line treatment of recurrent and/or metastatic head and neck squamous cell carcinoma(HNSCC)

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-522996-27-00

Acronym

GORTEC 2024-01

Enrollment

310

Registered

2025-12-18

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

recurrent and/or metastatic squamous cell carcinoma of the head and neck

Brief summary

Overall Survival

Detailed description

Objective response rate, Progression free survival, Disease control rate, safety assessments, pharmacokinetic characteristics, Immunogenicity assessment

Interventions

DRUGLigufalimab

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion.

DRUGivonescimab

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall Survival	—

Secondary

Measure	Time frame
Objective response rate, Progression free survival, Disease control rate, safety assessments, pharmacokinetic characteristics, Immunogenicity assessment	—

Countries

Belgium, France, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026