TY - JOUR
T1 - BESPOKE IO protocol
T2 - A multicentre, prospective observational study evaluating the utility of ctDNA in guiding immunotherapy in patients with advanced solid tumours
AU - Kasi, Pashtoon Murtaza
AU - Chakrabarti, Sakti
AU - Sawyer, Sarah
AU - Krainock, Michael
AU - Poklepovic, Andrew
AU - Ansstas, George
AU - Maninder, Minu
AU - Malhotra, Meenakshi
AU - Ensor, Joe
AU - Gao, Ling
AU - Eroglu, Zeynep
AU - Ellers, Sascha
AU - Billings, Paul
AU - Rodriguez, Angel
AU - Aleshin, Alexey
N1 - © 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.
PY - 2022/5/30
Y1 - 2022/5/30
N2 - 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.
AB - 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.
KW - dermatological tumours
KW - gastrointestinal tumours
KW - oncology
KW - respiratory tract tumours
KW - Immunologic Factors
KW - Prospective Studies
KW - Circulating Tumor DNA/genetics
KW - Humans
KW - Biomarkers, Tumor
KW - Neoplasms/genetics
KW - Multicenter Studies as Topic
KW - Immunotherapy
KW - Observational Studies as Topic
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UR - http://www.scopus.com/inward/citedby.url?scp=85131217838&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2021-060342
DO - 10.1136/bmjopen-2021-060342
M3 - Article
C2 - 35636789
AN - SCOPUS:85131217838
SN - 2044-6055
VL - 12
SP - e060342
JO - BMJ open
JF - BMJ open
IS - 5
M1 - e060342
ER -