Silk, Ann W.
O’Day, Steven J.
Kaufman, Howard L.
Bryan, Jennifer
Norrell, Jacqueline T.
Imbergamo, Casey
Portal, Daniella
Zambrano-Acosta, Edwin
Palmeri, Marisa
Fein, Seymour
Wu, Cai
Guerreiro, Leslie
Medina, Daniel
Bommareddy, Praveen K.
Zloza, Andrew
Fox, Bernard A.
Ballesteros-Merino, Carmen
Ren, Yixin
Shafren, Darren
Grose, Mark
Vieth, Joshua A.
Mehnert, Janice M.
Article History
Received: 21 June 2022
Accepted: 15 October 2022
First Online: 29 November 2022
Declarations
:
: A.W. Silk: grants/research support—Biohaven Pharmaceuticals, Replimune, Morphogenesis, Shattuck Laboratories, and Checkmate Pharmaceuticals; advisory board member—Bristol Myers Squibb, EMD Serono, Sanofi Genzyme, and Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA; consultant/independent contractor—WorldCare Clinical. S.J. O’Day: grants/research support—Biothera, Bristol Myers Squibb, Exicure, ImaginAB, Genocea, Shattuck Labs, Ultimovacs, Vyriad, and Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA; advisory board member—Bristol Myers Squibb, ImmunoSync, Biothera, Exicure, and Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. H.L. Kaufman: employee—Ankyra Therapeutics; advisory board member—Castle Biosciences and Marengo Therapeutics. S. Fein: consultant/independent contractor—CNF Pharma, LLC, contracted to Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. C. Wu: former employee of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA and stockholder in Merck & Co., Inc., Rahway, NJ, USA. L. Guerreiro: consultant/independent contractor—Practical Clinical Research Solutions Inc., contracted to Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. P.K. Bommareddy: employee—Replimune Inc. A. Zloza: grants/research support—Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA; advisory board member, consultant/independent contractor, and shareholder—PrimeVax Immuno-Oncology, Inc. B.A. Fox: employee—Earle A. Chiles Research Institute; grants/research support—NCI 5 R01 CA142779-09, Macrogenics, OncoSec, and Akoya; advisory board member—Akoya, AstraZeneca, Bristol Myers Squibb, Incyte, PrimeVax, Turnstone, UbiVac, and Ultivue; shareholder—PrimeVax, Turnstone, and UbiVac. Y. Ren: employee of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA and stockholder in Merck & Co., Inc., Rahway, NJ, USA. D. Shafren: employee—ImmvirX Pty Ltd. M. Grose: consultant/independent contractor—contracted directly by Viralytics. J.M. Mehnert: grants/research support—Amgen, AstraZeneca, Bristol Myers Squibb, Novartis, Polynoma, Sanofi, EMD Serono, Immunocore, Incyte, Macrogenics, and Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA; advisory board member—Array BioPharma, Bristol Myers Squibb, EMD Serono, and Sanofi/Regeneron; consultant/independent contractor—Amgen and Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA; honorarium—EMD Serono and Pfizer. J. Bryan, J.T. Norrell, C. Imbergamo, D. Portal, E. Zambrano-Acosta, M. Palmeri, D. Medina, C. Ballesteros-Merino, and J.A. Vieth: nothing to disclose.
: All patients provided written informed consent.
: Not applicable.
: The protocol was approved by an appropriate institutional review board or independent ethics committee at each center, and the study was conducted in accordance with local laws, Good Clinical Practice guidelines, and the Declaration of Helsinki.