Also new PK and immunogenicity tables were added to support the sample collections for participants in Parts D and E.The tables in this section were modified and added to support assessment for PK and immunogenicity in subjects enrolled in Parts A, B1, B2, C1, C2, D and E. Appendix 10 Statistical MethodologyUpdated Updated the BLRM-RD languages and related prior distributions for the combination phase to align with the protocol text. Revised Protocol No.: 04 Date: 31-May-2019 234 Approved 5.0 v Approved 1.0 v Clinical Protocol CA021002 BMS-986226 anti-ICOS SUMMARY OF KEY CHANGES FOR REVISED PROTOCOL 02 Section Number & Title Description of Change Brief Rationale Appendix 11: Prostate Cancer Working Group 3 (PCWG 3) Guidelines (with Modified Response Evaluation Criteria in Solid Tumors (RECIST) Criteria for Soft Tissue Lesion Assessment)Added new appendix for PCWG 3.Appendix added to support inclusion of PCWG 3 criteria for efficacy assessments. All Minor formatting and typographical corrections.Made corrections for clarity and consistency within the document. Revised Protocol No.: 04 Date: 31-May-2019 235 Approved 5.0 v Approved 1.0 v Clinical Protocol CA021002 BMS-986226 anti-ICOS Overall Rationale for the Revised Protocol 01, 20-Jul-2017 The primary reason for this amendment is to incorporate the preliminary safety cohorts, intra-patient dose escalation, and revised inclusion/exclusion criteria for certain tumor types and to align the protocol with respect to these changes. Summary of key changes of Revised Protocol 01 Section Number & TitleDescription of Change Brief Rationale Table 2-2: On-treatment Procedural Outline (CA021002); Table 2-5: Retreatment and Extended Treatment Procedural Outline for Preliminary Safety Cohorts and Parts A, B1, B2, and B3 Only (CA021002); Figure 5-1: Study Design Schematic; Section 5.1: Overall Design; Table 5.1-1:Study Cohorts per Part; Section 5.1.2: Treatment Phase; Section 5.1.2.1: Monotherapy Dose Escalation (Preliminary Safety Cohort and Part A); Section 5.1.2.1.1: Preliminary Safety Cohort; Section 5.1.2.1.2: Part A; Table 5.1-2: Dose Escalation (P reliminary Safety Cohort and Part A); Section 5.2; Number of Participants; Section 5.4.1: Rationale for BMS-986226 First-in-Human Dose (Preliminary Safety Cohort and Part A Monotherapy); Section 6.1: Inclusion Criteria; Table 7.1-1: Selection and Timing of Dose per Part; Section 7.1.1: Method of Treatment Assignment; Section 7.3: Dosage Modification; Section 7.3.1: Treatment Delay; Section 7.3.2: BMS-986226 Dose-limiting Toxicities; Table 9.5-1: A preliminary safety cohort of BMS-986226 administered at 2 mg and 8 mg every 4 weeks in a single participant with the possibility to offer intra-patient dose escalation was added to the protocol in all applicable areas, including procedural outlines, sampling schedules, inclusion criteria, study design, number of participants, rationale for st udy design, and rationale for dose. Modified the starting monotherapy dose of BMS-986226 based on available in vitro and in vivo data. Revised Protocol No.: 04 Date: 31-May-2019 236 Approved 5.0 v Approved 1.0 v Clinical Protocol CA021002 BMS-986226 anti-ICOS Summary of key changes of Revised Protocol 01 Section Number & TitleDescription of Change Brief Rationale Pharmacokinetic and Immunogenicity Sampling Schedule for BMS-986226, Nivolumab, and Ipilimumab (Parts A, B1, B2, and B3); Table 9.5-4: Additional and Retreatment Cycles Pharmacokinetic and Immunogenicity Sampling Schedule for BMS-986226, Nivolumab, and Ipilimumab (Preliminary Safety Cohorts and Parts A, B1, B2, and B3 Only); Section 10.1.1: Preliminary Safety Cohort and Dose Escalation (Part A) Section 6.1: Inclusion CriteriaThe inclusion criteria were modified as follows: 2.c) Edited so that participants in the study should have progressed on, or been intolerant to, all standard therapies Colorectal cancer (CRC) 3.a.iv) Added: Participants must have incurable, metastatic disease (ie, patients with disease that is potentially curable by surgical resection are not eligible for treatment). Non-small cell lung cancer (NSCLC) 3.c.i.2) Edited: Platinum-based chemotherapy may have been given in the adjuvant, neoadjuvant, or chemoradiation setting.