Study concept and design: Carvajal, Doyle, Panageas, Dickson, Wolchok, Schwartz.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Carvajal, Sosman, Joshua, Gajewski, Panageas, Hedvat, Ambrosini, Schwartz.
Critical revision of the manuscript for important intellectual content: Carvajal, Sosman, Quevedo, Milhem, Joshua, Kudchadkar, Linette, Gajewski, Lutzky, Lawson, Lao, Flynn, Albertini, Sato, Lewis, Doyle, Ancell, Panageas, Bluth, Erinjeri, Marr, Abramson, Dickson, Wolchok, Chapman, Schwartz.
Statistical analysis: Carvajal, Panageas, Schwartz.
Obtained funding: Carvajal, Doyle, Schwartz.
Administrative, technical, or material support: Carvajal, Sosman, Quevedo, Joshua, Linette, Flynn, Sato, Doyle, Bluth, Erinjeri, Marr, Abramson, Dickson, Schwartz.
Study supervision: Carvajal, Lutzky, Lawson, Doyle, Hedvat, Dickson, Wolchok, Chapman, Schwartz.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Kudchadkar reports consulting/honoraria and speaker’s fees from Genentech and Bristol-Myers Squibb and payment for development of educational presentations from RMEI and CancerNet; Dr Gajewski reports grants from Roche/Genentech, Bristol-Myers Squibb, Incyte, and Merck and consulting fees from Jouncs, Bayer, Boehringer-Ingelheim, and Abbvie; Dr Lutzky reports speaker’s fees from Genentech and Bristol-Myers Squibb; Dr Panageas reports travel reimbursement from AstraZeneca; and Dr Wolchok reports grants and other personal fees and nonfinancial support from Bristol-Myers Squibb, Medimmune, Merck, GlaxoSmithKline, ImClone/Eli Lilly, Ziopharm, Polynoma, and Psioxus. No other disclosures were reported.
Funding/Support: This study was sponsored by the Cancer Therapy Evaluation Program. Financial support for this trial was provided by the National Cancer Institute, the Conquer Cancer Foundation, Cycle for Survival, and the Fund for Ophthalmic Knowledge. The Division of Cancer Treatment and Diagnosis at the National Cancer Institute provided selumetinib for this clinical trial.
Role of the Sponsor: The Cancer Therapy Evaluation Program worked jointly with the academic coauthors under a confidentiality agreement to participate in the design and conduct of the study; the collection, management, analysis, and interpretation of the data; the review and approval of the manuscript; and the decision to submit the manuscript for publication. All drafts of the manuscript were written and prepared by the authors. The authors vouch for the accuracy and completeness of the reported data and the fidelity of this report to the protocol.
Previous Presentations: Presented in part at the Cancer Therapy Evaluation Program Early Drug Development meeting, October 3-4, 2011, Bethesda, Maryland; the 15th biennial meeting of the International Society of Ocular Oncology, November 14-17, 2011, Buenos Aires, Argentina; Macula 2012, January 20-21, 2012, New York, New York; the fourth annual Scientific Retreat of the Melanoma Research Alliance, March 1-2, Washington, DC; the 48th annual meeting of the American Society of Clinical Oncology, June 1-5, 2012, Chicago, Illinois; the 2012 Beijing International Melanoma Congress, November 2-4, 2012, Beijing, China; and the 49th annual meeting of the American Society of Clinical Oncology, May 31–June 4, 2013, Chicago, Illinois.
Additional Contributions: We acknowledge Daniel J. Paucar, BS, Sloane Smith, MPH, and Anne Fusco, MPA, all from Memorial Sloan Kettering Cancer Center, for their contributions to this study, which included data acquisition, data analysis, and administrative support. No compensation was provided for this work.