Radiotherapy With Double Checkpoint Blockade of Locally Advanced HNSCC

PHASE2CompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

September 20, 2018

Primary Completion Date

September 16, 2021

Study Completion Date

February 29, 2024

Conditions
Locally Advanced Head and Neck Squamous Cell Carcinoma
Interventions
COMBINATION_PRODUCT

Durvalumab + Tremelimumab + RT

Patients with an increased CD8+ tumor infiltrating immune cell density and at least clinically stable disease will receive radioimmunotherapy with the PD-L1 Inhibitor Durvalumab and the CTLA4-Inhibitor Tremelimumab (altogether 4 doses q4w including the induction dose) followed by maintenance therapy with Durvalumab (8 additional doses q4w).

Trial Locations (7)

40225

Düsseldorf, Universitätsklinikum, Klinik für Strahlentherapie und Radiologische Onkologie, Düsseldorf

60590

Frankfurt, Universitätsklinikum, Klinik für Strahlentherapie und Onkologie, Frankfurt

89075

Universitätsklinikum Ulm, Ulm

91054

Erlangen, Universitätsklinikum Strahlenklinik, Erlangen

93042

Universitätsklinikum Regensburg, Regensburg

09116

Klinik Chemnitz gGmbH, Chemnitz

01307

Dresden, Onkologische Gemeinschaftspraxis, Dresden

All Listed Sponsors
lead

University of Erlangen-Nürnberg Medical School

OTHER

NCT03426657 - Radiotherapy With Double Checkpoint Blockade of Locally Advanced HNSCC | Biotech Hunter | Biotech Hunter