Statistical Analysis
non-cervical cancer
CERVICAL CANCER
For each of the 2 cohorts of patients (cervical cancer and non-cervical cancer), a Simon two-stage optimal design was utilized. Each cohort was analyzed independently. In the first stage, 9 participants were enrolled. If 0 or 1 response were observed, then treatment with durvalumab and MEDI0457 would be considered futile, and enrollment would be stopped. If there were 2 or more participants per cohort who experienced radiographic responses, an additional 25 patients (34 total) were planned to be enrolled. It was prespecified by study leadership that both cohorts had to surpass the minimum response boundary in the first stage in order for both cohorts to expand into the second stage. Sample sizes were calculated with a one-sided 