PD-L1 Expression in Cancer (PECan Study).

Guy's and St Thomas' NHS Foundation Trust

Status: Enrolling

Conditions: Melanoma; Non-small Cell Lung Cancer

Treatments: Diagnostic Test: [99mTc]-NM-01 SPECT/CT

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04436406

IRAS 256684

Details and patient eligibility

About

Measurement of PD-L1 expression in cancer to monitor treatment response.

A prospective non-blinded, single centre, single interventional arm diagnostic imaging study.

To determine the baseline level and variability within and between patients and tumour types of PD-L1 expression in melanoma and non-small cell lung cancer in immunotherapy naïve patients using [99mTc]-anti-PD-L1 SPECT/CT and immunohistochemistry.

Full description

Using [99mTc]-labeled anti-PD-L1 single-domain antibody, this study aims to prospectively measure changes in PD-L1 expression determined with SPECT/CT imaging and correlate these changes with response to anti-PD(L)1 immunotherapy.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18 or above
• Patients with histologically confirmed NSCLC or melanoma scheduled for PD1/PDL1 immunotherapy alone or in combination with other systemic anti-cancer therapy.
• Willingness and ability to comply with scheduled study visits and tests.

Exclusion criteria

• Pregnant or lactating women
• Concomitant uncontrolled medical conditions
• Patients likely to require palliative radiotherapy within the first 12 weeks of treatment or radiotherapy to target lesion(s) received within preceding 42 days
• More than 3 months between IHC PDL1 and study recruitment
• Patients who have received other systemic anti-cancer therapy within preceding 14 days
• Prognosis less than 3 months
• Previous anticancer treatment with any checkpoint inhibitor or other immunotherapy, i.e. only immunotherapy naïve patients

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Advanced malignant disease (non-small cell lung cancer or malignant melanoma)

Experimental group

Description:

Group 1: Participants with non-small cell lung cancer (NSCLC) as per inclusion/exclusion criteria undergo baseline PD-L1 expression testing by immunohistochemistry and \[99m-Tc\]-anti-PD-L1 single-domain antibody SPECT/CT imaging at 0 and 9 weeks. FDG-PET/CT is also performed at baseline (0) and first follow-up (9) weeks scans, in addition to standard CT clinical imaging at 0, 9 and 18 weeks. Group 2: Participants with malignant melanoma (MM) as per inclusion/exclusion criteria undergo baseline PD-L1 expression testing by immunohistochemistry and \[99m-Tc\]-anti-PD-L1 single-domain antibody SPECT/CT imaging at 0 and 12 weeks. FDG-PET/CT is also performed as standard clinical imaging at baseline (0), first follow-up (12) weeks and 24 weeks.

Treatment:

Diagnostic Test: [99mTc]-NM-01 SPECT/CT