Pembrolizumab versus placebo as adjuvant therapy in completely resected stage IIB or IIC melanoma (KEYNOTE-716): a randomised, double-blind, phase 3 trial - PubMed

Conflict of interest statement

Declaration of interests JJL reports research funding to their institution for clinical studies from Merck Sharp & Dohme (MSD), AbbVie, Agios, Array, Astellas, AstraZeneca, Bristol-Myers Squibb, Corvus, Day One, EMD Serono, Fstar, Genmab, Ikena, Immatics, Incyte, Kadmon, KAHR, Macrogenics, Moderna, Nektar, Next Cure, Numab, Palleon, Pfizer, Replimune, Rubius, Servier, Scholar Rock, Synlogic, Takeda, Trishula, Tizona, and Xencor; membership on data safety monitoring boards for AbbVie and Immutep; membership on scientific advisory boards with no stock ownership or stock options for 7 Hills, Bright Peak, Fstar, Inzen, RefleXion, Xilioo, and with stock for Actym, Alphamab Oncology, Arch Oncology, Kanaph, Mavu, NeoTx, Onc.AI, Pyxis, and Tempest; compensation for consultancy with AbbVie, Alnylam, Bayer, Bristol-Myers Squibb, CheckMate, Codiak, Crown, Cstone, Day One, Eisai, EMD Serono, Flame, Genentech, Gilead, HotSpot, Kadmon, KQS, Janssen Ikena, Immunocore, Incyte, Macrogenics, Merck, Mersana, Nektar, Novartis, Pfizer, Regeneron, Ribon, Rublus, Silicon, Synlogic, Synthekine, TRex, Werewold, and Xencor; and a provisional patent for cancer immunotherapy (PCT/US18/36052: Microbiome Biomarkers for anti-PD-1/PD-L1 responsiveness: diagnostic, prognostic and therapeutic uses thereof). PR reports research funding to their institution from MSD and Pfizer and honoraria for lectures and advisory board participation from MSD, Bristol Myers Squibb, Novartis, Pierre Fabre, Sanofi, Merck, Philogen, and Blueprint Medicines. PQ reports research finding to their institution for clinical studies from MSD, and honoraria as consultant or advisor role from Bristol Myers Squibb, MSD, Merck, Novartis, Pierre Fabre, Sun Pharma, Sanofi-Regeneron, and Roche. MDV reports research finding to their institution for clinical studies from MSD and honoraria as consultant or advisor for Novartis, Bristol Myers Squibb, MSD, and Pierre Fabre. JM reports research funding to their institution for clinical studies from MSD; honoraria from Bristol Myers Squibb, MSD, Roche, Novartis, and Pierre Fabre; and consultant or advisor roles for Bristol Myers Squibb and MSD. VC-S reports research funding to their institution for clinical studies from MSD; reimbursement for travel and accommodation for medical congress from Bristol Myers Squibb and Pierre Fabre; and honoraria for advisory board participation from Novartis and Pierre Fabre. LdlCM reports research funding to their institution for clinical studies from Celgene, MSD, and Roche; reimbursement for travel expenses from Roche; and consultant or advisor roles for Bristol Myers Squibb, MSD, Novartis, and Roche. MAK reports research funding to their institution for clinical studies from MSD and MSD Australia; fees as speaker from Bristol Myers Squibb, Novartis, Merck Serono, and MSD Australia; and reimbursement for travel from Bristol Myers Squibb and Roche. DS reports research funding to their institution for clinical studies from Bristol Myers Squibb, MSD, Novartis, Amgen, and Array; grants paid to their institution from Bristol Myers Squibb, MSD, Novartis, Merck-EMD, Philogen, Pfizer, Array, InflarX, OncoSec, Replimune, Neracare, Nektar, SunPharma, Sandoz, and UltimoVacs; reimbursement for travel from Bristol Myers Squibb, Merck, Novartis, Merck-EMD, Pfizer, Pierre Fabre, InflarX, NeraCare, and Nektar; and non-financial support from Bristol Myers Squibb, MSD, Novartis, Merck-EMD, Pierre-Fabre, InFlarX, Neracare, Nektar, SunPharma, and Sandoz. GVL reports research funding to their institution for clinical studies from MSD and fees as a consultant or advisor from Aduro Biotech, Amgen, Arrary Biopharma, Boehringer Ingelheim International GmbH, Bristol Myers Squibb, Evaxion Biotech A/S, Hexal AG, Highlight Therapeutics S L, MSD, Novartis Pharma AG, OncoSec, Pierre Fabre, QBiotics Group, Regeneron Pharmaceuticals, SkylineDX BV, and Specialised Therapeutics Australia. PAA reports research funding to their institution for clinical studies from MSD, Bristol Myers Squibb, Roche-Genentech, Sanofi, and Pfizer and fees as a consultant or advisor from Bristol Myers Squibb, Roche-Genentech, MSD, Novartis, Merck Serono, Pierre Fabre, AstraZeneca, Sun Pharma, Sanofi, Idera, Sandoz, Immunocore, 4SC, Nektar, Italfarmaco, Boehringer Ingelheim, Eisai, Regeneron, Daiichi Sankyo, Pfizer, Oncosec, Nouscom, Lunaphore, Seagen, and ITeos. MM reports research funding to their institution for clinical studies from MSD and personal fees from MSD, Pierre Fabre, Novartis, Bristol Myers Squibb, and Sanofi. FDG and J-JG report research funding to their institutions for clinical studies from MSD. AH reports research funding to their institution for clinical studies from MSD and fees for advisory board membership from Novartis, Bristol Myers Squibb, and MSD. RD reports research funding to their institution for clinical studies from MSD and consulting or advisory roles with MSD, Novartis, Roche, Bristol Myers Squibb, Amgen, Takeda, Pierre Fabre, Sun Pharma, Sanofi, Catalym, Second Genome, Regeneron, Alligator, T3 Pharma, MaxiVAX SA, Pfizer, and touchIME. CR reports research funding to their institution for clinical studies from MSD and fees as a consultant or advisor for Amgen, AstraZeneca, Bristol Myers Squibb, MSD, Novartis, Pfizer, Pierre Fabre, Roche, and Sanofi. MSC reports research funding to their institution for clinical studies for MSD and honoraria for consulting from Bristol Myers Squibb, Eisia, IDEAYA Biosciences, Merck Serono, MSD, Novartis, Oncosec, Pierre Fabre, Qbiotics, Roche, and Sanofi. PM reports research funding to their institution for clinical studies from MSD, Amgen, Johnson & Johnson, Merck Serono, Novartis, Pfizer, Sanofi, and Sun Pharma; honoraria from Amgen, Bristol Myers Squibb, Merck, MSD, Novartis, Pierre Fabre, Roche/Genentech, and Sanofi; consulting or advisory roles for Amgen, Bristol Myers Squibb, Merck, MSD, Novartis, Pierre Fabre, Roche, and Sanofi; fees for speakers bureau from Amgen, Bristol Myers Squibb, MSD, Novartis, Roche, and Sanofi; and reimbursement for travel, accommodation, and expenses from Amgen, Bristol Myers Squibb, MSD, Novartis, Pierre Fabre, Roche, Sanofi, and Sun Pharma. AP reports research funding to their institution for clinical studies from MSD; fees for consulting or advisory roles from Novartis; and fees for speakers bureau from Bristol Myers Squibb. VKS reports research funding to their institution for clinical studies from MSD and Neogene Therapeutic and fees for participation in independent data safety monitoring committees and participation in advisory boards from Bristol Myers Squibb, Eisai, Novartis, Merck, Regeneron, and Replimune. RAS reports research funding to their institution from MSD and fees for professional services from F Hoffmann-La Roche, Evaxion, Provectus Biopharmaceuticals Australia, Qbiotics, Novartis, MSD, NeraCare, AMGEN, Bristol Myers Squibb, Myriad Genetics, and GSK. RAS is supported by an Australian National Health and Medical Research Council Practitioner Fellowship (APP1141295). JMK reports research funding to their institution from MSD, Amgen, Bristol Myers Squibb, Checkmate Pharmaceuticals, Immunocore, Iovance Biotherapies, Novartis Pharmaceuticals, Castle Biosciences, and Merck; personal fees from Amgen, Ankyra Therapeutics, Axio Research/Instil Bio, Bristol Myers Squibb, Checkmate Pharmaceuticals, DermTech, Elsevier, Harbour BioMed, Immunocore, Iovance Biotherapies, Istari Oncology, Millenium Pharm/Takeda Pharm, Natera, Novartis Pharmaceutical, OncoCyte Corporation, OncoSec Medical, Pfizer, Scopus BioPharma, Merck, Becker Pharmaceutical Consulting, Fenix Group International, Intellisphere LLC/Cancer Network, IQVIA, Replimune, and SR One Capital Managment. KC, SJD, SA, and NI are employees of and own stock in MSD. AMME reports research funding to their institution for clinical studies from MSD; fees for advisory board membership for Merck, Agenus, Biocad, BioInvent, BioNTech, Bristol Myers Squibb, CatalYm, Ellipses, Galecto, GSK, IO Biotech, ISA Pharmaceuticals, Merck, MSD, Nektar, Novartis, Pfizer, Sellas, SkylineDX, TigaTx, and TxDiscovery; personal fees for independent data monitoring committee for Biocad, GSK, Pfizer, and Novartis; fees for participation in speakers bureau from Biocad, Bristol Myers Squibb, and Merck; and equity in IO Biotech, SkylineDX.