PD-L1 ImagiNg to prediCt Durvalumab Treatment Response in HNSCC

Conditions

• Head and Neck Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

Non-invasive imaging of tumor PD-L1 expression with 89Zr-labeled durvalumab PET/CT predicts response to durvalumab.

Key Dates

Start date

Apr 15, 2019

Status verified

Jan 2022

Primary completion

Dec 17, 2020

Completion

Dec 9, 2021

Study Design

Enrollment

33 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

• Experimental: PD-L1 imaging
  89Zr-durvalumab iv injection followed by a PET/CT scan at day 5 after injection.

Primary Outcome Measure

Tumor uptake of 89Zr-durvalumab [ Time Frame: 1 year ]

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