PD-L1 Expression in Cancer (PECan Study).

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Measurement of PD-L1 Expression in Cancer to Monitor Treatment Response.

Conditions
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Non-small Cell Lung Cancer, Melanoma

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Advanced malignant disease (non-small cell lung cancer or malignant melanoma)<br>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. | Diagnostic Test: [99mTc]-NM-01 SPECT/CT<br>* Technetium labelled anti-PD-L1 single-domain antibody (NM-01) single-photon emission computed tomography (SPECT)/CT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change in PD-L1 expression (using [99mTc] SPECT) in NSCLC. | PD-L1 expression reported by measurement of tumour:blood pool ratio and/or SUV of [99mTc]-anti-PD-L1-sdAb uptake on SPECT. Measurement at baseline and 9 weeks will be compared to determine % change. Standard clinical imaging assessment at 9 and 18 weeks used as comparators. | Up to 18 weeks | 
| Percentage change in PD-L1 expression (using [99mTc] SPECT) in melanoma lesions. | PD-L1 expression reported by measurement of tumour:blood pool ratio and/or SUV of [99mTc]-anti-PD-L1-sdAb uptake on SPECT. Measurement at baseline and 12 weeks will be compared to determine % change. Standard clinical imaging assessment at 12 and 24 weeks used as comparators. | Up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Report PD-L1 tumour expression (using [99mTc] SPECT) of immunotherapy naive participants compared to PD-L1 expression determine by standard immunohistochemistry. | Correlation between PD-L1 expression reported by measurement of tumour:blood pool ratio and/or SUV of [99mTc]-anti-PD-L1-sdAb uptake on SPECT and PD-L1 expression determined by standard of care immunohistochemistry. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immunotherapy, checkpoint inhibitors, molecular imaging, non-small cell lung cancer, melanoma