This study was sponsored by Bristol-Myers Squibb, which provided the study drug and worked jointly with the senior academic authors to design, collect, analyze, and interpret the study results. All the authors signed a confidentiality agreement with the sponsor. The protocol, including a detailed statistical analysis plan, is available with the full text of this article at NEJM.org. All drafts of the manuscript were prepared by the authors with editorial assistance from a professional medical writer paid by the sponsor. All the authors vouch for the accuracy and completeness of the reported data and for the fidelity of this report to the trial protocol, and all the authors made the decision to submit the manuscript for publication.
This phase 1 study assessed the safety, anti-tumor activity, and pharmacokinetics of BMS-936558, a fully human IgG4-blocking monoclonal antibody directed against PD-1, in patients with selected advanced solid tumors. All patients (or their legal representatives) gave written informed consent before enrollment. The antibody was administered as an intravenous infusion every 2 weeks of each 8-week treatment cycle. Response was assessed after each treatment cycle. Patients received treatment for up to 2 years (12 cycles), unless they had a complete response, unacceptable adverse effects, or progressive disease or they withdrew consent. In clinically stable patients, study treatment could be continued beyond apparent initial disease progression until progression was confirmed, as outlined by proposed immune-response criteria.15 (link) Patients with stable disease or an ongoing objective response (complete or partial response) at the end of treatment were followed for up to 1 year and were offered retreatment for 1 additional year in the event of disease progression.
Safety evaluations (clinical examination and laboratory assessments) were conducted for all treated patients at baseline and regular intervals. The severity of adverse events was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0.16
This phase 1 study assessed the safety, anti-tumor activity, and pharmacokinetics of BMS-936558, a fully human IgG4-blocking monoclonal antibody directed against PD-1, in patients with selected advanced solid tumors. All patients (or their legal representatives) gave written informed consent before enrollment. The antibody was administered as an intravenous infusion every 2 weeks of each 8-week treatment cycle. Response was assessed after each treatment cycle. Patients received treatment for up to 2 years (12 cycles), unless they had a complete response, unacceptable adverse effects, or progressive disease or they withdrew consent. In clinically stable patients, study treatment could be continued beyond apparent initial disease progression until progression was confirmed, as outlined by proposed immune-response criteria.15 (link) Patients with stable disease or an ongoing objective response (complete or partial response) at the end of treatment were followed for up to 1 year and were offered retreatment for 1 additional year in the event of disease progression.
Safety evaluations (clinical examination and laboratory assessments) were conducted for all treated patients at baseline and regular intervals. The severity of adverse events was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0.16
