Table 3.
Statistical hypotheses and decision rules of the PEVOsq basket trial
| Cohorts | p0 (%) | p1 (%) | Alpha (%) | Power (%) | No. of assessable/included patients | No. of objective responses required |
|---|---|---|---|---|---|---|
| Head and neck | 10 | 35 | 5 | 85 | 19/21 | ≥5 CR/PR |
| Anus | 15 | 40 | 5 | 85 | 23/25 | ≥7 CR/PR |
| Cervix | 5 | 30 | 5 | 90 | 16/18 | ≥3 CR/PR |
| Vulva | 5 | 30 | 10 | 85 | 10/11 | ≥2 CR/PR |
| Lung | 15 | 40 | 5 | 85 | 23/25 | ≥7 CR/PR |
| Penis | 5 | 30 | 10 | 85 | 10/11 | ≥2 CR/PR |
CR, complete response; p0, maximal unacceptable rate of patient presenting an objective response for whom the experimental treatment will be considered as insufficiently active; p1, minimal acceptable rate of patient presenting an objective response for whom the experimental treatment will be considered as sufficiently active; PR, partial response.