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Brief Title: PD-L1 ImagiNg to prediCt Durvalumab Treatment Response in HNSCC
Official Title: PINCH - PD-L1 ImagiNg to prediCt Durvalumab Treatment Response in HNSCC
Study ID: NCT03829007
Brief Summary: Non-invasive imaging of tumor PD-L1 expression with 89Zr-labeled durvalumab PET/CT predicts response to durvalumab.
Detailed Description: The programmed death 1 (PD1)/ programmed death ligand 1 (PD-L1) pathway plays an important role in regulating the T-cell anti tumor response. Blocking this interaction with the anti PD-L1 monoclonal antibody durvalumab has proven to be effective resulting in durable disease control rates. Currently, PD-L1 expression as determined by immune histochemistry (IH) is the best available biomarker for treatment response, but standardized scoring criteria are lacking and the risk for sampling errors exists. Molecular imaging using 89Zr-labeled antibodies may overcome these limitations, enabling the visualization of PD-L1 expression in primary and metastatic tumor lesions and providing information on the in vivo accessibility of the PD-L1 target following intravenous administration. Besides, a baseline FDG-PET scan will be performed.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Amsterdam UMC, Amsterdam, , Netherlands
UMC Groningen, Groningen, , Netherlands
Leiden UMC, Leiden, , Netherlands
Radboudumc, Nijmegen, , Netherlands
Name: carla van Herpen, Prof
Affiliation: Radboud University Medical Center
Role: PRINCIPAL_INVESTIGATOR