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- W4361953670 abstract "<div>AbstractPurpose:<p>Despite the expansion of immune checkpoint inhibitor (ICI) indications, the relationship between ICI dose and toxicity or response is not well established. To understand this correlation, we performed a meta-analysis of ICI trials that used dose escalation.</p>Experimental Design:<p>We searched PubMed and abstracts presented at (inter)national meetings for trials using FDA-approved ICIs. The reported rates of grade 3–5 adverse events (G3–5 AE), immune-related adverse events (irAE), and response were correlated with doses within each ICI using marginal exact generalized linear models.</p>Results:<p>A total of 74 trials (7,469 patients) published between January 2010 and January 2017 were included. For ipilimumab, the incidence of G3–5 AEs was 34% with a significant 27% reduced risk in lower doses (<i>P</i> = 0.002). However, no relationship was observed between dose and irAEs or response. For nivolumab, the incidence of G3–5 AEs was 20.1% which was lower in non–small cell lung cancer (NSCLC) compared with renal cell carcinoma (RCC) or melanoma (<i>P</i> ≤ 0.05) with no dose-toxicity relationship. In melanoma and NSCLC, a dose–response association was observed, which was not observed in RCC. For pembrolizumab, the incidence of G3–5 AEs was 13.3%, which was lower in melanoma compared with NSCLC (<i>P</i> = 0.03) with no dose-toxicity relationship. In melanoma, lower dose levels correlated with decreased odds of response (<i>P</i> = 0.01), a relationship that was not observed in NSCLC.</p>Conclusions:<p>Our analysis shows a lack of consistent dose-toxicity or dose–response correlation with ICIs. Therefore, dose escalation is not an appropriate design to conduct ICI studies. Here we present an innovative trial design for immune-modulating agents.</p></div>" @default.
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- W4361953670 date "2023-03-31" @default.
- W4361953670 modified "2023-09-26" @default.
- W4361953670 title "Data from Early 3+3 Trial Dose-Escalation Phase I Clinical Trial Design and Suitability for Immune Checkpoint Inhibitors" @default.
- W4361953670 doi "https://doi.org/10.1158/1078-0432.c.6530246.v1" @default.
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