Kristeleit, Rebecca S. https://orcid.org/0000-0003-3825-1326
Drew, Yvette
Oza, Amit M.
Domchek, Susan M.
Banerjee, Susana https://orcid.org/0000-0002-8840-7934
Glasspool, Rosalind M. https://orcid.org/0000-0002-5000-1680
Balmaña, Judith
Chen, Lee-may
Patel, Manish R.
Burris, Howard A.
Safra, Tamar
Borrow, Jennifer
Lin, Kevin K.
Goble, Sandra
Maloney, Lara
Shapira-Frommer, Ronnie
Funding for this research was provided by:
Clovis Oncology, Inc.
Article History
Received: 17 May 2022
Revised: 27 September 2022
Accepted: 12 October 2022
First Online: 8 December 2022
Competing interests
: RSK has received institutional funding from Clovis Oncology for this clinical trial; reports clinical trial grants from Merck Sharp & Dohme; has served as a consultant from Basilea Pharmaceutica and Shattuck Pharma; has received honoraria from Clovis Oncology, AstraZeneca, GlaxoSmithKline, and Incyte; received travelling support from AstraZeneca, GlaxoSmithKline, and Sierra Oncology; has served on data safety monitoring boards or advisory boards for Clovis Oncology, AstraZeneca, BeiGene, Eisai, GlaxoSmithKline, Incyte, iTeos Therapeutics, PharmaMar and Roche. YD has contributed to the development of rucaparib and has received royalty payments from Newcastle University for this work; has received research funding from Clovis Oncology, AstraZeneca, Merck KGaA, and Verastem; and has received honoraria for advisory boards/speakers fees from Clovis Oncology, AstraZeneca, Genmab, GlaxoSmithKline, Merck and Tesaro. AMO reports institutional research grants from AstraZeneca; served on an advisory board (uncompensated) for GlaxoSmithKline; served on advisory boards and steering committees (uncompensated) for Clovis Oncology and AstraZeneca; served as a principal investigator on investigator-initiated trials for Clovis Oncology, AstraZeneca, and GlaxoSmithKline. SMD has received research funding from Clovis Oncology and AstraZeneca; and has received honoraria from Clovis Oncology, AstraZeneca, and Bristol Myers Squibb. SB has served on advisory boards and received honoraria from Clovis Oncology, AstraZeneca, Genmab, GlaxoSmithKline, Immunogen, Merck Serono, Merck Sharp & Dohme, Mersana, Pfizer, Roche, Seattle Genetics, and Tesaro; received honoraria for lectures from AstraZeneca/Merck Sharp & Dohme, GlaxoSmithKline, Pfizer, Roche, and Tesaro; received support for travel or accommodation from NuCana and Tesaro; and reports institutional funding from AstraZeneca, GlaxoSmithKline and Tesaro. RMG reports grant funding for investigator-initiated studies from Clovis Oncology, Boehringer Ingelheim and Lilly/Ignyta; institutional fees from Novartis; institutional drug donation from GSK; personal fees from Clovis Oncology, AstraZeneca, and GlaxoSmithKline/Tesaro, Immunogen, Merck Sharp & Dohme and Sotio; and conference registration fees from GSK. Judith Balmaña has served on advisory boards for Clovis Oncology, AstraZeneca, and Bristol Myers Squibb; and has received support for travel from AstraZeneca. L-mC has received institutional funding from Clovis Oncology, AstraZeneca, Genentech, and GlaxoSmithKline/Tesaro for this clinical trial and others. MRP reports a leadership position with ION Pharma; has received honoraria from Adaptive Biotechnologies, Bayer, Genentech, Janssen Oncology, Pfizer, and Pharmacyclics; has served in a consulting or advisory role for Pharmacyclics/Janssen and Pfizer/EMD Serono; has served on speakers’ bureaus for Celgene, Exelixis, Genentech/Roche, and Taiho Pharmaceutical; his institution has received research funding from Clovis Oncology, Acerta Pharma, ADC Therapeutics, Agenus, Aileron Therapeutics, Artios, AstraZeneca, Bayer, Bicycle Therapeutics, BioNTech AG, BioTheryX, Black Diamond Therapeutics, Boehringer Ingelheim, Calithera Biosciences, Celgene, Checkpoint Therapeutics, CicloMed, Curis, Cyteir Therapeutics, Daiichi Sankyo, eFFECTOR Therapeutics, EMD Serono, Erasca, Evelo Biosciences, Forma Therapeutics, Genetec/Roche, Gilead Sciences, GlaxoSmithKline, H3 Biomedicine, Hengrui Therapeutics, Hutchison MediPharma, IgM Biosciences, Ignyta, Incyte, Jacobio Pharmaceuticals, Janssen, Jounce Therapeutics, Klus Pharma, Kymab, Lilly, Loxo Oncology, LSK BioPartners, Lycera, Mabspace, MacroGenics, Merck, Millennium, Mirati Therapeutics, Moderna Therapeutics, NGM Biopharmaceuticals, Novartis, Nurix, ORIC, Pfizer, Phoenix Molecular Designs, Placon, Portola Pharmaceuticals, Prelude Therapeutics, Puget Sound Biotherapeutics, PureTech, QiLu Pharmaceutical, Relay Therapeutics, Revolution Medicines, Ribon Therapeutics, Samumed, Seven and Eight Biopharmaceuticals, Silicon Therapeutics, Stemline Therapeutics, Syndax, Synthorx, Taiho Pharmaceutical, Takeda, TeneoBio, Tesaro, TopAlliance BioSciences, Treadwell Therapeutics, Vedanta Biosciences, Verastem Oncology, Vigeo, Xencor, and Zymeworks. HAB reports payment for consulting services from AstraZeneca, Celgene, Forma Therapeutics, and Incyte; has received payment for his expert testimony from Novartis; has performed noncompensated consulting services for Bayer, Daiichi Sankyo, GRAIL, Novartis, and Pfizer; and his institution has received grants for conduct of clinical trials from Clovis Oncology, Agios, Arch, Array BioPharma, Arvinas, AstraZeneca, Bayer, BIND Therapeutics, BioAtla, BioMed Valley Discoveries, Boehringer Ingelheim, Bristol Myers Squibb, CicloMed, CytomX Therapeutics, eFFECTOR Therapeutics, Foundation Medicine, Gilead Sciences, GlaxoSmithKline, Harpoon Therapeutics, Incyte, Janssen, Jounce Therapeutics, Kyocera, Lilly, Macrogenics, MedImmune, Merck, miRNA Therapeutics, Moderna Therapeutics, Novartis, Pfizer, Revolution Medicines, Roche/Genentech, Seattle Genetics, Takeda/Millennium, Tesaro, TG Therapeutics, Verastem, and Vertex. Dr. Burris is employed by and has a leadership position at HCA Healthcare/Sarah Cannon Research Institute and owns stock in that company. TS declares no conflict of interest. Jennifer Borrow, KKL, SG and LM are employees of Clovis Oncology and may own stock or have stock options in that company. RS-F has received research grants from Merck Sharp & Dohme; and has received speaker honoraria from AstraZeneca, Bristol Myers Squibb, Medison, Merck Sharp & Dohme, Neopharm and Novartis.
: The study was approved by an institutional review board at each study site and was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice Guidelines of the International Council for Harmonisation.
: Not applicable.