Funding

This study was funded by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. The funder participated in study design, data analysis and interpretation, and manuscript writing, and maintained the study database. All authors had full access to the data and had final responsibility for the decision to submit the manuscript for publication.

Conflict of interest

Laurent Mortier has received consulting fees and travel support from MSD, BMS, Novartis, and Pierre Fabre. Lisa Villabona, Marie Beylot-Barry, Francesca Spada, Michel De Pontville, and Enrique Espinosa declare that they have no conflicts of interest that might be relevant to the contents of this article. Ben Lawrence has received honoraria and travel support from MSD. Ana Arance has received research funding from MSD, honoraria from MSD and Merck Serono, and travel support from MSD and BMS. Marcus O. Butler has received research funding from Merck, Takara Bio, and Novartis; consulting fees from Bristol Myers Squibb, Merck, Novartis, Adaptimmune, Immunocore, GlaxoSmithKline, Sanofi, Sun Pharma, Instil Bio, IOVANCE, Pfizer, Ideaya Bio, Medison, LaRoche Possey, and Regeneron; and honoraria from Sanofi, Bristol Myers Squibb, Merck, Pfizer, and Novartis; and has participated on a safety review committee for Adaptimmune and GlaxoSmithKline. Philippe Saiag has received research funding and consulting fees from Merck Serono. Mahtab Samimi has received research funding from SOTIO and travel support from BMS and MSD, has participated on advisory boards for Merck and Pfizer, and is chair of EADV. Paolo A. Ascierto has received research support from Bristol Myers Squibb, Roche-Genentech, Pfizer, and Sanofi; consulting fees from Bristol Myers Squibb, Roche-Genentech, Merck Sharp & Dohme, Novartis, Merck Serono, Pierre-Fabre, Sun Pharma, Sanofi, Sandoz, Italfarmaco, Nektar, Pfizer, Lunaphore, Medicenna, Bio-Al Health, ValoTx, RepImmune, and Bayer; and travel support from Pfizer, Bio-AI Health, and RepImmune; and has participated on advisory boards for Bristol Myers Squibb, Roche-Genentech, Merck Sharp & Dohme, Novartis, AstraZeneca, Boehringer Ingelheim, Eisai, Regeneron, Daiichi Sankyo, Oncosec, Nouscom, Seagen, iTeos, and Erasca. Michele Maio has received consulting fees, honoraria, and travel support from, and has participated in advisory boards for, BMS, Roche, MSD, Merck, Sanofi, GSK, AstraZeneca, Pierre Fabre, Alfasigma, Eli Lilly, Amgen, Sciclone, Incyte, and Ionctura; and owns stock in Epigen and Teravance. Alfonso Berrocal has received consulting fees from MSD and BMS and honoraria and travel support from MSD. Jaume Capdevila has received research funding from Novartis, Pfizer, AstraZeneca, Advanced Accelerator Applications, Eisai, Amgen, and Bayer; and consulting fees from Novartis, Pfizer, Ipsen, Exelixis, Bayer, Eisai, Advanced Accelerator Applications, Amgen, Sanofi, Lilly, Huchinson Pharma, ITM, Advanz, Merck Serono, Esteve, and Roche. Max Levin has received lecturing fees from Bristol Myers Squibb, Roche, and Merck Sharp & Dohme. Debasmita Das is an employee of Merck & Co., Inc., Rahway, NJ, USA. Clemens Krepler is an employee of, and owns stock in, Merck & Co., Inc., Rahway, NJ, USA. Dmitri Grebennik is an employee of Merck & Co., Inc., Rahway, NJ, USA. Vanna Chiarion-Sileni has received travel support from Pierre-Fabre and Sanofi; has participated on advisory boards for Pierre-Fabre and Merck Sharp & Dohme.

Ethics approval

The study protocol and all amendments were approved by the appropriate institutional review board or ethics committee at each center (Table S2, see the electronic supplementary material). The study was conducted in accordance with the protocol, Good Clinical Practice Guidelines, and the Declaration of Helsinki.

Consent to participate

All patients provided written informed consent.

Consent for publication

Not applicable.

Availability of data and material

Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (MSD) is committed to providing qualified scientific researchers access to anonymized data and clinical study reports from the company’s clinical trials for the purpose of conducting legitimate scientific research. MSD is also obligated to protect the rights and privacy of trial participants and, as such, has a procedure in place for evaluating and fulfilling requests for sharing company clinical trial data with qualified external scientific researchers. The MSD data sharing website (available at: http://engagezone.msd.com/ds_documentation.php) outlines the process and requirements for submitting a data request. Applications will be promptly assessed for completeness and policy compliance. Feasible requests will be reviewed by a committee of MSD subject matter experts to assess the scientific validity of the request and the qualifications of the requestors. In line with data privacy legislation, submitters of approved requests must enter into a standard data-sharing agreement with MSD before data access is granted. Data will be made available for request after product approval in the USA and EU or after product development is discontinued. There are circumstances that may prevent MSD from sharing requested data, including country or region-specific regulations. If the request is declined, it will be communicated to the investigator. Access to genetic or exploratory biomarker data requires a detailed, hypothesis-driven statistical analysis plan that is collaboratively developed by the requestor and MSD subject matter experts; after approval of the statistical analysis plan and execution of a data-sharing agreement, MSD will either perform the proposed analyses and share the results with the requestor or will construct biomarker covariates and add them to a file with clinical data that is uploaded to an analysis portal so that the requestor can perform the proposed analyses.

Code availability

Not applicable.

Author contributions

Acquisition of the data: LM, LV, BL, MOB, MB-B, PS, MS, FS, MD, MM, AB, EE, ML, DD, VCS. Analysis of the data: LM, PS, DD, CK, DG. Interpretation of the results: LM, LV, BL, AA, MB-B, PS, PAA, MM, JC, ML, DD, CK, DG, VCS. Drafting of the manuscript: LM, PS, DD. Critically reviewing or revising the manuscript for important intellectual content: LM, LV, BL, AA, MOB, MB-B, PS, MS, PAA, FS, MD, MM, AB, EE, JC, ML, DD, CK, DG, VCS.