NorthWest Biotherapeutics Inc (NWBO)

[dr_lowenstein]

a few, possible, but not relevant as that is NOT a primary endpoint

Primary Outcome Measures :
Cell cycle-related signature [ Time Frame: Up to 6 years ]
Expansion of T cell receptor (TCR) clones [ Time Frame: Up to 6 years ]
Two-sample T-test with Bonferroni adjustment will be used to compare the increase number of expanded TCR clones after dendritic cell (DC) vaccination with PD-1 blockade in Group A versus (vs) DC vaccination with a placebo in Group B.

Incidence of adverse events (AEs) [ Time Frame: Up to 30 days post treatment ]
Adverse events will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. All patients who receive any amount of pembrolizumab/placebo or ATL-DC vaccination will be evaluable for toxicity, serious adverse events (SAEs), and events of clinical interest (ECIs).