Combination Study With Eftilagimod Alpha (a Soluble LAG-3 Fusion Protein) and Pembrolizumab in Patients With Recurrent or Metastatic HNSCC
Completed · Phase 2
Conditions studied: HNSCC
In brief
Evaluate the safety and efficacy of eftilagimod alpha in combination with pembrolizumab against pembrolizumab alone in 1st line metastatic or recurrent HNSCC with programmed death-ligand 1 (PD-L1) positive (combined positive score \[CPS\] ≥1) tumors, and determine the efficacy and safety of efti plus pembrolizumab in patients with PD-L1 negative tumors.
Key facts
- Study ID
- NCT04811027
- Run by
- Immutep S.A.S.
- People needed
- 171
- Starts
- 2021-08-27
- Expected to finish
- 2025-11-05
- Last updated by the study team
- 2025-12-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Alabama at Birmingham (UAB) - O'Neal Cancer Center — Birmingham, Alabama, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Oncology Consultants — Houston, Texas, United States
- Macquarie University Hospital — Macquarie Park, New South Wales, Australia
- AZ Sint-Jan Brugge — Bruges, Belgium
- Antwerp University Hospital — Edegem, Belgium
- Centre Hospitalier Universitaire (CHU) de Liege — Liège, Belgium
- AZ Nikolaas — Sint-Niklaas, Belgium
- Rigshospitalet — Copenhagen, Denmark
- Herlev Hospital — Herlev, Denmark
- Universitätsklinikum Bonn — Bonn, North Rhine-Westphalia, Germany
- University Hospital Essen — Essen, Germany
- Nationales Centrum für Tumorerkrankungen Heidelberg — Heidelberg, Germany
- Universitätsklinikum Ulm — Ulm, Germany
- The Oncology Institute "Prof Dr Ion Chiricuta" I.O.C.N. — Cluj-Napoca, Romania
- Vall d'Hebron Institute of Oncology (VHIO) — Barcelona, Spain
- Hospital de la Santa Creu i de Sant Pau — Barcelona, Spain
- Institut Català d'Oncologia - Hospital Universitari de Girona — Girona, Spain
- Hospital Universitario Lucus Augusti — Lugo, Spain
- Hospital Universitario Ramón y Cajal — Madrid, Spain
- START Madrid (Hospital Universitario Fundación Jiménez Díaz) — Madrid, Spain
- Hospital 12 Octubre — Madrid, Spain
- Hospital Universitario Miguel Servet — Zaragoza, Spain
- Arensia Exploratory Medicine Llc — Kapitanivka, AL, Ukraine
- Institute of Cancer Science - Beatson West of Scotland Cancer Centre — Glasgow, United Kingdom
Full record on ClinicalTrials.gov
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