Biomarker-based Study in R/M SCCHN

Phase 2 Unknown 340 enrolled European Organisation for Research and Treatment of Cancer - EORTC

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a biomarker-driven trial that will enroll patients with recurrent or metastatic squamous cell carcinoma of the head and neck progressing after first-line platinum-based chemotherapy. Based on potential biomarkers and molecular alterations identified in the biopsy from the central platform, patients will be allocated in different cohorts. There will be biomarker-positive patient cohorts and immunotherapy cohorts.

Timeline

Start: 2017-11-16
Primary completion: 2025-06
Completion: 2025-12

Publications

Galot R, Le Tourneau C, Guigay J, Licitra L, Tinhofer I, Kong A, Caballero C, Fortpied C, Bogaerts J, Govaerts AS, Staelens D, Raveloarivahy T, Rodegher L, Laes JF, Saada-Bouzid E, Machiels JP. Personalized biomarker-based treatment strategy for patients with squamous cell carcinoma of the head and neck: EORTC position and approach. Ann Oncol. 2018 Dec 1;29(12):2313-2327. doi: 10.1093/annonc/mdy452.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Afatinib	Small molecule	40 mg	Oral
Subject	Durvalumab	Monoclonal antibody	1500 mg	Intravenous
Subject	Monalizumab	Monoclonal antibody	10 mg/kg	Intravenous
Subject	Monalizumab	Monoclonal antibody	750 mg	Intravenous
Subject	Niraparib	Small molecule	300 mg	Oral
Subject	Palbociclib	Small molecule	125 mg	Oral
Subject	RAGIFILIMAB	Monoclonal antibody	300 mg	Intravenous
Background	Bleomycin	Unknown	—	—
Background	Carboplatin	Small molecule	—	—
Background	Docetaxel	Small molecule	—	—
Background	Gemcitabine	Small molecule	—	—
Background	Methotrexate	Small molecule	—	—
Background	Mitomycine	Unknown	—	—
Background	Paclitaxel	Small molecule	—	—
Background	fluorouracil	Small molecule	—	—

Biomarker-based Study in R/M SCCHN

Summary

Timeline

Publications

Drugs

Indications