Expansion cohorts phase
toxicity, renal and lung cancers, lung cancer
LUNG CANCER, HEAD AND NECK CANCER
Depending on the results of toxicity from phase I, a sequential or concomitant scheme will be selected according to decision diagrams.20 patients will be included in each cohort (including 6 to 9 patients from phase 1 for the lung cancer cohort). Each cohort will be analyzed independently.20 patients in each cohort will allow for preliminary estimates of efficacy endpoints. A total sample of 18 subjects (assuming 10% of non-evaluable patients) provides a 95% CI with a precision of 22%, 23%, and 24% when the estimated rates of 6-month PFS (under binomial assumption and with no censored data) are 35%, 30%, and 45%, respectively, in head and neck, renal and lung cancers. For head and neck cancer, the 6-month PFS estimate of 35% was selected on the basis of the 6-month PFS rates achieved in Keynote-048 [