Ethics approval

The study was compliant with International Council for Harmonisation Good Clinical Practice guidelines and the Declaration of Helsinki. The protocol (MK-8353–013) was approved by an institutional review board or independent ethics committee at each site.

Consent to participate

Written informed consent was obtained from all participants before enrollment.

Competing interest

Nehal J. Lakhani: Research funding for clinical trial costs from Merck, during the conduct of the study; research funding for clinical trial costs from ALX Therapeutics, Ascentage, Asana, Beigene, Constellation Pharma/Morphosys, Alexion, Cerulean, Forty Seven, Alpine, Merck, Pfizer, InhibRx, Regeneron, Apexian, Formation Biologics (forbius), Symphogen, CytomX, Sapience Therapeutics, Incyte, Jounce, Livzon, Northern Biologics, Innovent Biologics, Ikena, Odonate, Loxo/Lilly, Ikena, Mersana, Macrogenics, Helsinn, Seagen/Pfizer, Shattuck Labs, Samumed, Astellas, Alkermes/Mural Oncology, SK Life Sciences, KSQ Therapeutics/Roche, Tizona, Servier, Sapience, Repare Therapeutics, Gilead, Bristol Myers/Celgene, GSK, Janssen, Artios, Arcus Bio, Volastra, Incyte, Revolution Medicines, outside the submitted work; and honoraria for Advisory Board from Innovent Biologics and Ikena. Howard Burris III: Research funding to institution from AbbVie, Agios, Arch Oncology, ARMO Biosciences, Array BioPharma, Arvinas, AstraZeneca, Bayer, BeiGene, BioAtla, Boehringer Ingelheim, Bristol-Myers Squibb, CALGB, Celgene, Coordination Pharmaceuticals, CytomX, Lilly, EMD Serono, Roche/Genentech, Gossamer Bio, Harpoon Therapeutics, Hengrui Therapeutics, Incyte, Jounce Therapeutics, Kymab, MacroGenics, MedImmune, Merck, Millennium/Takeda, Moderna, NGM Biopharmaceuticals, Novartis, Pfizer, Revolution Medicines, Ryvu Therapeutics, Foundation Medicine, SeaGen, Tesaro, TG Therapeutics, Verastem, Vertex Pharmaceuticals, XBiotech, Zymeworks. Consulting fees (non-compensated) from Bristol-Myers Squibb and Novartis. Consulting fees paid to institution from AstraZeneca, GRAIL, Incyte, Roche, Vincerx Pharma. Stock ownership (self) HCA Healthcare. Wilson H. Miller Jr: Personal fees for consultant or Honoraria for BMS, Merck & Co., Inc., Rahway, NJ, USA, Roche, Novartis, Amgen, GSK, Sanofi, Mylan and EMD Serono. Research grant to institution from CIHR; CRS; SWCRF, Research Funding to Institution from Merck, BMS, Novartis, GSK, Roche, AstraZeneca, Methlgene, MedImmune, Sanofi, Array, MiMic, Ocellaris, Astellas, Pfizer, Genentech and Seagen. Mo Huang: Employee of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, and stockholder in Merck & Co., Inc., Rahway, NJ, USA. Lin-Chi Chen: Employee of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA and stockholder in Merck & Co., Inc., Rahway, NJ, USA. Lillian L. Siu: Advisory Role/Consultation: Merck, Pfizer, AstraZeneca, Roche, GSK, Voronoi, Arvinas, Navire, Relay, Marengo, Daiichi Sankyo, Amgen, Medicenna, LTZ Therapeutics, Tubulis, Nerviano, Pangea, Incyte, Gilead. Research Support (institution): Merck, Novartis, Bristol-Myers Squibb, Pfizer/SeaGen, Boehringer-Ingelheim, GlaxoSmithKline, Roche/Genentech, AstraZeneca/Medimmune, Bayer, Abbvie, Amgen, Symphogen, EMD Serono, 23Me, Daiichi Sankyo, Gilead, Marengo, Incyte, LegoChem, Loxo/Eli Lilly, Medicenna, Takara. Leadership position: Treadwell Therapeutics (founder). Stock ownership: Agios.