- Participants must have measurable disease as defined in RECIST (v1.1) as the presence of at least one lesion not previously irradiated, that can be accurately measured at baseline greter than or equal to 10mm in the longest diameter (except lymph nodes which must have short axis greater than or equal to 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and which is suitable for accurate repeated measurements.