For subjects who have measurable disease at baseline Table 4.1-1 provides a summary of the overall response status calculation at each timepoint. Table 4.1-1: Timepoint Response: Subjects with Target (+/– Non-Target) Disease Target Lesions Non-Target Lesions New Lesions Overall Response CR CR No CR CR NonCR/non-PD No PR CR Not evaluated No PR PR NonPD or not all evaluated No PR SD NonPD or not all evaluated No SD Not all evaluated NonPD No NE PD Any Yes or No PD Any PD Yes or No PD Any Any Yes PD Abbreviation: NE =not evaluable Missing Assessments and Not Evaluable Designation When no imaging/measurement is done at all at a particular timepoint, the subject is not evaluable at that timepoint. If only a subset of lesion measurements are made at an assessment, the subject is also considered NE at that timepoint, unless a convincing argument can be made that the Revised Protocol No.: 04 Date: 31-May-2019 187 Approved 5.0 v Approved 1.0 v Clinical Protocol CA021002 BMS-986226 anti-ICOS contribution of the individual missing lesion(s) would not have changed the assigned timepoint response. 4.1.1 Confirmation Scans • Verification of Response: Confirmation of PR and CR is required at least 4 weeks following initial assessment to ensure responses identified are not the result of measurement error. 4.2 Best Overall Response: All Timepoints The best overall response is determined once all the data for the subject are known. It is the best response recorded from the start of the st udy treatment un til the d ate of objectively documented PD based on RECIST v1.1, taking into account any requirement for confirmation or the date of subsequent anti-cancer therapy, whichever occ urs first in the study. The subject’s best overall response assignment will depend on the findings of both target and non-target disease and will also take into consideration the appearance of new lesions. The best overall response is defined as the best response across all timepoints with subsequent confirmation. CR or PR may be claimed only if the criteria for each are met at a subsequent timepoint as specified in the protocol (generally 4 weeks later).In this circumstance, the best overall response can be interpreted as specified in Table 4.2-1. When SD is believed to be best response, it must meet the protocol specified minimum time from baseline. Measurements must have met the SD criteria at least once after study entry at a minimum interval (in general, not less than 6 to 8 weeks) that is defined in the study protocol. Table 4.2-1: Best Overall Response When Confirmation of CR and PR Is Required Overall Response Overall Response Best Overall Response First Timepoint Subsequent Timepoint CR CR CR CR PR SD, PD, or PRa CR SDSD provided minimum criteria for SD duration met, otherwise, PD CR PDSD provided minimum criteria for SD duration met, otherwise, PD CR NE SD provided minimum criteria for SD duration met, otherwise NE PR CR PR Revised Protocol No.: 04 Date: 31-May-2019 188 Approved 5.0 v Approved 1.0 v Clinical Protocol CA021002 BMS-986226 anti-ICOS Table 4.2-1: Best Overall Response When Confirmation of CR and PR Is Required Overall Response Overall Response Best Overall Response First Timepoint Subsequent Timepoint PR PR PR PR SD SD PR PDSD provided minimum criteria for SD duration met, otherwise, PD PR NE SD provided minimum criteria for SD duration met, otherwise NE NE NE NE . aIf a CR is truly met at the first timepoint, then any disease seen at a subsequent timepoint, even disease meeting PR criteria relative to baseline, makes the disease PD at that point (since the disease must have reappeared after CR). The best response would depend on whether minimum duration for SD was met. However, sometimes ‘CR’ may be claimed when subsequent scans suggest small lesions were likely still present and in fact the subject had PR, not CR at the first timepoint. Under these circumstances, the origi nal CR should be changed to PR and the best response is PR. 4.3 Duration of Response 4.3.1 Duration of Overall Response The duration of overall response is measured from the time measurement criteria are first met for CR/PR (whichever is first recorded) un til the first d ate that recurrent or PD is objectively documented (taking as reference for PD th e smallest measurements recorded on study). The duration of overall CR is measured from the time measurement criteria are first met for CR until the first date that recurrent disease is objectively documented. 4.3.2 Duration of Stable Disease SD is measured from the start of the treatment (in randomized trials, from date of randomization) until the criteria for progression are met, taking as re ference the smallest sum on study (if the baseline sum is the smallest, this is the reference for calculation of PD). CR (Complete Remission) The designation of CR requires all of the following: 1.