§In addition to these eight patients continuing adjuvant treatment, two additional patients in the nivolumab group were reported to be continuing treatment; however, the treatment status of these patients could not be confirmed prior to the closure of their ...
We excluded patients previously treated with an agent targeting T-cell costimulation or checkpoint pathways. Patients received intravenous nivolumab 0路1-10 mg/kg every 2 weeks in the dose-escalation phase (3+3 design). Nivolumab 3 mg/kg was given every 2 weeks in the dose-expansion phase to...
2.2. Study design and treatment CheckMate 078 was a randomized, open-label, multinational, phase 3 study conducted across China, Russia, and Singapore. Patients were randomized 2:1 to receive intravenous nivolumab 3 mg/kg every 2 weeks (Q2W) or docetaxel 75 mg/m2 every 3 weeks (Q3W)...
Study design and participants CheckMate 275 was a multicentre, single-arm, phase 2 trial of nivolumab (Bristol-Myers Squibb, Lawrenceville, NJ, USA) monotherapy done at 63 sites in 11 countries (Australia, Belgium, Czech Republic, Finland, Germany, Italy, Japan, Poland, Spain, Sweden, and the...
Because the data were reported anonymously, the requirement for informed consent was waived. The study was approved by the Institutional Review Board of the Cancer Institute Hospital. Author Contributions All authors made substantial contributions to conception and design, acquisition of data, analysis an...
Study design and participants This randomised, open-label, international, phase 3 trial was done at 128 hospitals and cancer centres in 23 countries (appendix p 2). Patients were enrolled in the trial if they were aged at least 18 years and had received a diagnosis of unresectable or metastat...
Study Design CheckMate 078 was a randomized, open-label, multinational phase III trial that enrolled patients at 32 hospitals and cancer/medical centers in China, Russia, and Singapore (Supplemental Fig. 1). The study was conducted in accordance with the Declaration of Helsinki and the Internationa...
Study design and participants We did a multicentre, non-comparative, open-label, phase 1/2 study in patients with advanced hepatocellular carcinoma with or without chronic viral hepatitis (HCV or HBV) to evaluate the safety and efficacy of nivolumab as a monotherapy (CheckMate 040). The dose-es...
The CheckMate 214 study design and statistical analyses details have been published previously.2., 4. Briefly, adults with treatment-naïve aRCC with a clear cell component were randomised 1:1 to the NIVO+IPI or SUN arms and stratified by region and IMDC risk status (favourable, intermediat...
Study design and patients CheckMate 214 is a phase III, global, open-label, randomized trial. A detailed description of the CheckMate 214 methodology has been previously published.6 Briefly, adults with previously untreated aRCC with a clear cell component were stratified by geographic region and ...