What question did this study set out to answer?

This trial aims to evaluate the safety, maximum tolerated dose, and immunological effects of MDX-1106.

Safety and activity of MDX-1106 (ONO-4538), an anti-PD-1 monoclonal antibody, in patients with selected refractory or relapsed malignancies

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This trial aims to evaluate the safety, maximum tolerated dose, and immunological effects of MDX-1106.
First in human phase I trial
Single IV doses of MDX-1106 at various mg/kg levels
Patients with refractory metastatic cancers without autoimmune disease
Tumor response assessed via RECIST criteria.
24 patients enrolled with well-tolerated doses
No severe adverse events related to MDX-1106 observed
Three patients showed significant lesional regressions
Objective tumor responses not observed within initial 8 weeks
Further evaluations on pharmacokinetics and immunological effects underway.

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Phase I trial shows tolerability of MDX-1106 in patients with refractory cancers, suggesting immunological effects.

Brahmer et al. (2008) studied this question.

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