PD-L1 Expression in Cancer (PECan Study).

Not Applicable

Recruiting

• Conditions: Melanoma; Non-small Cell Lung Cancer
• Interventions: Diagnostic Test: [99mTc]-NM-01 SPECT/CT

• Registration Number: NCT04436406
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-03-09
• Study Start: 2020-03-11
• Study First Submitted QC: 2020-06-15
• Study First Posted: 2020-06-18
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-13
• Last Update Posted: 2022-12-15
• Primary Completion: 2023-10-31
• Study Completion: 2024-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Advanced malignant disease (non-small cell lung cancer or malignant melanoma)	[99mTc]-NM-01 SPECT/CT	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.

Primary Outcome Measures

Name	Time	Method
Percentage change in PD-L1 expression (using [99mTc] SPECT) in NSCLC.	Up to 18 weeks	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.
Percentage change in PD-L1 expression (using [99mTc] SPECT) in melanoma lesions.	Up to 24 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Report PD-L1 tumour expression (using [99mTc] SPECT) of immunotherapy naive participants compared to PD-L1 expression determine by standard immunohistochemistry.	Baseline	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.

Trial Locations

Locations (1)

Guy's and St Thomas' NHS Foundation Trust; 🇬🇧 London, United Kingdom