PD-L1 Expression in Cancer (PECan Study). (PECan)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Melanoma; Non-small Cell Lung Cancer
• Intervention / Treatment: Diagnostic test: [99mTc]-NM-01 SPECT/CT

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel J Hughes, MBBS MRCP; Phone Number: 88378 020 7188 7188; Email: daniel.hughes@kcl.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom
    • Recruiting
    • Guy's and St Thomas' NHS Foundation Trust
    • Contact: Daniel J Hughes, MBBS MRCP; Phone Number: 88378 (0044)20 7188 7188; Email: daniel.hughes@kcl.ac.uk
    • Contact: Gary JR Cook; Phone Number: 88378 (0044)20 7188 7188; Email: gary.cook@kcl.ac.uk
    • Principal Investigator: Gary JR Cook
    • Sub-Investigator: Daniel J Hughes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Advanced malignant disease (non-small cell lung cancer or malignant melanoma); 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; Technetium labelled anti-PD-L1 single-domain antibody (NM-01) single-photon emission computed tomography (SPECT)/CT

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Collaborators: NanoMab Technology (UK) Limited
• Investigators: Principal Investigator: Gary JR Cook, King's College London, London, UK

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2020
• Primary Completion (Anticipated): October 31, 2023
• Study Completion (Anticipated): January 31, 2024

Study Registration Dates

• First Submitted: March 9, 2020
• First Submitted That Met QC Criteria: June 15, 2020
• First Posted (Actual): June 18, 2020

Study Record Updates

• Last Update Posted (Actual): December 15, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: immunotherapy; non-small cell lung cancer; melanoma; checkpoint inhibitors; molecular imaging
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Lung Neoplasms; Neuroendocrine Tumors; Nevi and Melanomas; Carcinoma, Non-Small-Cell Lung; Melanoma
• Other Study ID Numbers: IRAS 256684

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No