NCT03829007

PD-L1 ImagiNg to prediCt Durvalumab Treatment Response in HNSCC

PINCH - PD-L1 ImagiNg to prediCt Durvalumab Treatment Response in HNSCC

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	PD-L1 imaging	89Zr-durvalumab injection followed by a PET/CT scan 5 days after injection
DRUG	Durvalumab	Durvalumab treatment is initiated after the PET/CT scan in a fixed dose of 1500 mg iv q4w

Timeline

• Start date: 2019-04-15
• Primary completion: 2020-12-17
• Completion: 2021-12-09
• First posted: 2019-02-04
• Last updated: 2022-01-10

Locations

4 sites across 1 country: Netherlands