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PDL1 Expression in Cancer (PECan Study). (PECan)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04436406
Recruitment Status : Not yet recruiting
First Posted : June 18, 2020
Last Update Posted : June 18, 2020
Sponsor:
Collaborator:
NanoMab
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

Brief Summary:

Measurement of PDL1 expression in cancer to monitor treatment response.

A prospective single centre non-randomised exploratory observational study.

To determine the baseline level and variability within and between patients and tumour types of PDL1 expression in melanoma and non-small cell lung cancer in immunotherapy naïve patients using [99mTc]-anti-PDL1 SPECT and immunohistochemistry.


Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Melanoma Diagnostic Test: [99mTc]-NM01 SPECT Not Applicable

Detailed Description:
Using [99mTc]-labeled anti-PDL1 single-domain antibody, this study aims to prospectively measure changes in PD-L1 expression determined with SPECT imaging and correlate these changes with response to anti-PD(L)1 immunotherapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Measurement of PDL1 Expression in Cancer to Monitor Treatment Response.
Estimated Study Start Date : August 1, 2020
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Arm 1: Non-small cell lung cancer

Participants with non-small cell lung cancer as per inclusion/exclusion criteria undergo baseline and PD-L1 expression testing by immunohistochemistry and [99m-Tc]-anti-PDL1 single-domain antibody SPECT 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.

Diagnostic Test: [99mTc]-NM01 SPECT
Technetium labelled anti-PD-L1 single-domain antibody (NM01) single-photon emission computed tomography (SPECT)

Arm 2: Melanoma

Participants with malignant melanoma as per inclusion/exclusion criteria undergo baseline and PD-L1 expression testing by immunohistochemistry and [99m-Tc]-anti-PDL1 single-domain antibody SPECT 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]-NM01 SPECT
Technetium labelled anti-PD-L1 single-domain antibody (NM01) single-photon emission computed tomography (SPECT)




Primary Outcome Measures :
  1. Percentage change in PD-L1 expression (using [99mTc] SPECT) in NSCLC. [ Time Frame: 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.


  2. Percentage change in PD-L1 expression (using [99mTc] SPECT) in melanoma lesions. [ Time Frame: 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 :
  1. Report PD-L1 tumour expression (using [99mTc] SPECT) of immunotherapy naive participants compared to PD-L1 expression determine by standard immunohistochemistry. [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

i) Aged 18 or above ii) Patients with histologically confirmed NSCLC or melanoma scheduled for PD1/PDL1 immunotherapy alone or in combination with other systemic anti-cancer therapy.

iii) Willingness and ability to comply with scheduled study visits and tests.

Exclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04436406


Contacts
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Contact: Daniel J Hughes, MBBS MRCP 020 7188 7188 ext 88378 daniel.hughes@kcl.ac.uk

Locations
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United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
Contact: Daniel J Hughes, MBBS MRCP    (0044)20 7188 7188 ext 88378    daniel.hughes@kcl.ac.uk   
Contact: Gary JR Cook    (0044)20 7188 7188 ext 88378    gary.cook@kcl.ac.uk   
Principal Investigator: Gary JR Cook         
Sub-Investigator: Daniel J Hughes         
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
NanoMab
Investigators
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Principal Investigator: Gary JR Cook King's College London, London, UK
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Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04436406    
Other Study ID Numbers: IRAS 256684
First Posted: June 18, 2020    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guy's and St Thomas' NHS Foundation Trust:
immunotherapy
checkpoint inhibitors
molecular imaging
non-small cell lung cancer
melanoma
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Melanoma
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas