Alvarez, Janet A.
Shi, Qian
Dasari, Arvind
Garcia-Aguilar, Julio
Sanoff, Hanna
George, Thomas J.
Hong, Theodore
Yothers, Greg
Philip, Philip
Nelson, Garth
Al Baghdadi, Tareq
Alese, Olatunji B.
Zambare, Wini
Omer, Dana
Verheij, Floris S.
Bercz, Aron
Kim, Min Jung
Buckley, James
Williams, Hannah
George, Manju
Garcia, Reese
Gallagher, Phuong
O’Reilly, Eileen M.
Meyerhardt, Jeffrey A.
Crawley, Jamie
Shergill, Ardaman
Horvat, Natally
Romesser, Paul B.
Hall, William
Smith, J. Joshua
Article History
Received: 22 May 2024
Accepted: 17 June 2024
First Online: 26 July 2024
Declarations
:
: As of March 1, 2019, all U.S.-based sites must be members of the NCI Central Institutional Review Board (NCI CIRB) in order to participate in CTEP and Division of Cancer Prevention studies open to the NCTN and NCI Community Oncology Research Program (NCORP) Research Bases. In addition, U.S.-based sites must accept the NCI CIRB review to activate new studies at the site after March 1, 2019. Local IRB review will continue to be accepted for studies that are not reviewed by the CIRB, or if the study was previously open at the site under the local IRB. International sites should continue to submit Research Ethics Board (REB) approval to the CTSU Regulatory Office following country-specific regulations. Refer to the protocol in supplementary material for additional information. The patient must be aware of the neoplastic nature of his/her disease and willingly consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts. Current human protection committee approval of this protocol and a consent form is required prior to patient consent and registration. Patients with an impaired decision-making capacity may be enrolled in this study, where institutional policy and IRB of record allow.
: Appropriate consent was obtained for images used in this manuscript.
: JA declare that they have no competing interests.QS reports consulting/advisory role from Yiviva Inc, Boehringer Ingelheim Pharmaceuticals, Inc, Regeneron Pharmaceuticals, Inc., Hoosier Cancer Research Network, Kronos Bio, and Mirati Therapeutics Inc; Honorarium/speaker role from Chugai Pharmaceutical Co., Ltd (to myself), research funds from Celgene/BMS, Roche/Genentech, Janssen, Novartis (to institution).AD reports grants or contracts from HUTCHMED International Corporation, Eisai and Crinetics; consulting fees from HUTCHMED, Crinetics, and AAA; and Advisory Board participation for Oncobay.JGA claims ownership/equity interests for Intuitive Surgical Inc.JGA serves as a consulting/advisory role for Medtronic, Intuitive Surgical, and Johnson & Johnson.HS research funding: AstraZeneca, Roche, Amgen, Bristol-Myers Squibb, Pfizer, BioMed Valley Discoveries, Rgenix, Exelixis.TJG reports consulting/advisory role from Pfizer/Array, Tempus Labs, and Billion To One and is supported by an NIH/NCI Cancer Center Support Grant (P30 CA247796) and an NIH/NCI NCI-sponsored Clinical Trial Research Specialist (R50 CA281930).PP declare that they have no competing interests.GN declare that they have no competing interests.TA reports advisory role from AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Genentech.OA reports a consulting or advisory role from Taiho Oncology, Pfizer, QED Therapeutics, Seagen, Bristol Myers Squibb, AADi, Seagen and research funding from Bristol-Myers Squibb, Ipsen, Taiho Pharmaceutical, Calithera Biosciences, Corcept Therapeutics, PCI Biotech, SynCoreBio, Hutchison MediPharma, GlaxoSmithKline, Transcenta.WH declare that they have no competing interests.DO declare that they have no competing interests.FV declare that they have no competing interests.AB declare that they have no competing interests.MK declare that they have no competing interests.JB declare that they have no competing interests.HW declare that they have no competing interests.MG declare that they have no competing interests.RG declare that they have no competing interests.PG declare that they have no competing interests.EO reports research funding to institution: Genentech/Roche, BioNTech, AstraZeneca, Arcus, Elicio, Parker Institute, NIH/NCI, Digestive Care, Break Through Cancer and consulting/DSMB in Arcus, Alligator, Agenus, BioNTech, Ipsen, Merck, Moma Therapeutics, Novartis, Syros, Leap Therapeutics, Astellas, BMS, Fibrogen, Revolution Medicine, Merus Agios (spouse), Genentech-Roche (spouse), Eisai (spouse) Servier (Spouse).JM declare that they have no competing interests.NH declare that they have no competing interests.PBR is an EMD Serono consultant and reports support for travel from Elekta and Philips Healthcare and prior research funding from EMD Serono.JJS received travel support for fellow education from Intuitive Surgical (2015).JJS served as a clinical advisor for Guardant Health (2019).JJS served as a clinical advisor for Foundation Medicine (2022).JJS served as a consultant and speaker for Johnson and Johnson (2022).JJS serves as a clinical advisor and consultant for GSK (2023–24).