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BESPOKE IO protocol: a multicentre, prospective observational study evaluating the utility of ctDNA in guiding immunotherapy in patients with advanced solid tumours

INTRODUCTION: Immunotherapy (IO) has transformed the treatment paradigm for a wide variety of solid tumours. However, assessment of response can be challenging with conventional radiological imaging (eg, iRECIST), which do not precisely capture the unique response patterns of tumours treated with IO...

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Autores principales: Kasi, Pashtoon Murtaza, Chakrabarti, Sakti, Sawyer, Sarah, Krainock, Michael, Poklepovic, Andrew, Ansstas, George, Maninder, Minu, Malhotra, Meenakshi, Ensor, Joe, Gao, Ling, Eroglu, Zeynep, Ellers, Sascha, Billings, Paul, Rodriguez, Angel, Aleshin, Alexey
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9152946/
https://www.ncbi.nlm.nih.gov/pubmed/35636789
http://dx.doi.org/10.1136/bmjopen-2021-060342
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author Kasi, Pashtoon Murtaza
Chakrabarti, Sakti
Sawyer, Sarah
Krainock, Michael
Poklepovic, Andrew
Ansstas, George
Maninder, Minu
Malhotra, Meenakshi
Ensor, Joe
Gao, Ling
Eroglu, Zeynep
Ellers, Sascha
Billings, Paul
Rodriguez, Angel
Aleshin, Alexey
author_facet Kasi, Pashtoon Murtaza
Chakrabarti, Sakti
Sawyer, Sarah
Krainock, Michael
Poklepovic, Andrew
Ansstas, George
Maninder, Minu
Malhotra, Meenakshi
Ensor, Joe
Gao, Ling
Eroglu, Zeynep
Ellers, Sascha
Billings, Paul
Rodriguez, Angel
Aleshin, Alexey
author_sort Kasi, Pashtoon Murtaza
collection PubMed
description INTRODUCTION: Immunotherapy (IO) has transformed the treatment paradigm for a wide variety of solid tumours. However, assessment of response can be challenging with conventional radiological imaging (eg, iRECIST), which do not precisely capture the unique response patterns of tumours treated with IO. Emerging data suggest that circulating tumour DNA (ctDNA) can aid in response assessment in patients with solid tumours receiving IO. The short half-life of ctDNA puts it in a unique position for early treatment response monitoring. The BESPOKE IO study is designed to investigate the clinical utility of serial ctDNA testing to assess treatment response using a tumour-informed, bespoke ctDNA assay (Signatera) and to determine its impact on clinical decision-making with respect to continuation/discontinuation, or escalation/de-escalation of immunotherapy in patients with advanced solid tumours. METHODS AND ANALYSIS: The BESPOKE IO is a multicentre, prospective, observational study with a goal to enroll over 1500 patients with solid tumours receiving IO in up to 100 US sites. Patients will be followed for up to 2 years with serial ctDNA analysis, timed with every other treatment cycle. The primary endpoint is to determine the percentage of patients who will have their treatment regimen changed as guided by post-treatment bespoke ctDNA results along with standard response assessment tools. The major secondary endpoints include progression-free survival, overall survival and overall response rate based on the ctDNA dynamics. ETHICS AND DISSEMINATION: The BESPOKE IO study was approved by the WCG Institutional Review Board (Natera-20–043-NCP BESPOKE Study of ctDNA Guided Immunotherapy (BESPOKE IO)) on 22 February 2021. Data protection and privacy regulations will be strictly observed in the capturing, forwarding, processing and storing patients’ data. Natera will approve the publication of any study results in accordance with the site-specific contract. TRIAL REGISTRATION NUMBER: NCT04761783.
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spelling pubmed-91529462022-06-16 BESPOKE IO protocol: a multicentre, prospective observational study evaluating the utility of ctDNA in guiding immunotherapy in patients with advanced solid tumours Kasi, Pashtoon Murtaza Chakrabarti, Sakti Sawyer, Sarah Krainock, Michael Poklepovic, Andrew Ansstas, George Maninder, Minu Malhotra, Meenakshi Ensor, Joe Gao, Ling Eroglu, Zeynep Ellers, Sascha Billings, Paul Rodriguez, Angel Aleshin, Alexey BMJ Open Oncology INTRODUCTION: Immunotherapy (IO) has transformed the treatment paradigm for a wide variety of solid tumours. However, assessment of response can be challenging with conventional radiological imaging (eg, iRECIST), which do not precisely capture the unique response patterns of tumours treated with IO. Emerging data suggest that circulating tumour DNA (ctDNA) can aid in response assessment in patients with solid tumours receiving IO. The short half-life of ctDNA puts it in a unique position for early treatment response monitoring. The BESPOKE IO study is designed to investigate the clinical utility of serial ctDNA testing to assess treatment response using a tumour-informed, bespoke ctDNA assay (Signatera) and to determine its impact on clinical decision-making with respect to continuation/discontinuation, or escalation/de-escalation of immunotherapy in patients with advanced solid tumours. METHODS AND ANALYSIS: The BESPOKE IO is a multicentre, prospective, observational study with a goal to enroll over 1500 patients with solid tumours receiving IO in up to 100 US sites. Patients will be followed for up to 2 years with serial ctDNA analysis, timed with every other treatment cycle. The primary endpoint is to determine the percentage of patients who will have their treatment regimen changed as guided by post-treatment bespoke ctDNA results along with standard response assessment tools. The major secondary endpoints include progression-free survival, overall survival and overall response rate based on the ctDNA dynamics. ETHICS AND DISSEMINATION: The BESPOKE IO study was approved by the WCG Institutional Review Board (Natera-20–043-NCP BESPOKE Study of ctDNA Guided Immunotherapy (BESPOKE IO)) on 22 February 2021. Data protection and privacy regulations will be strictly observed in the capturing, forwarding, processing and storing patients’ data. Natera will approve the publication of any study results in accordance with the site-specific contract. TRIAL REGISTRATION NUMBER: NCT04761783. BMJ Publishing Group 2022-05-30 /pmc/articles/PMC9152946/ /pubmed/35636789 http://dx.doi.org/10.1136/bmjopen-2021-060342 Text en © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Oncology
Kasi, Pashtoon Murtaza
Chakrabarti, Sakti
Sawyer, Sarah
Krainock, Michael
Poklepovic, Andrew
Ansstas, George
Maninder, Minu
Malhotra, Meenakshi
Ensor, Joe
Gao, Ling
Eroglu, Zeynep
Ellers, Sascha
Billings, Paul
Rodriguez, Angel
Aleshin, Alexey
BESPOKE IO protocol: a multicentre, prospective observational study evaluating the utility of ctDNA in guiding immunotherapy in patients with advanced solid tumours
title BESPOKE IO protocol: a multicentre, prospective observational study evaluating the utility of ctDNA in guiding immunotherapy in patients with advanced solid tumours
title_full BESPOKE IO protocol: a multicentre, prospective observational study evaluating the utility of ctDNA in guiding immunotherapy in patients with advanced solid tumours
title_fullStr BESPOKE IO protocol: a multicentre, prospective observational study evaluating the utility of ctDNA in guiding immunotherapy in patients with advanced solid tumours
title_full_unstemmed BESPOKE IO protocol: a multicentre, prospective observational study evaluating the utility of ctDNA in guiding immunotherapy in patients with advanced solid tumours
title_short BESPOKE IO protocol: a multicentre, prospective observational study evaluating the utility of ctDNA in guiding immunotherapy in patients with advanced solid tumours
title_sort bespoke io protocol: a multicentre, prospective observational study evaluating the utility of ctdna in guiding immunotherapy in patients with advanced solid tumours
topic Oncology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9152946/
https://www.ncbi.nlm.nih.gov/pubmed/35636789
http://dx.doi.org/10.1136/bmjopen-2021-060342
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