See Se ction 9.1. Assessment of Participant Survival StatusXPartici pant status will be assessed by either a clinic visit or a telephone contac t. New Anti-cancer TherapiesXXX XAny ne w anti-cancer therapies (including surgery and radiotherapy) will be recorded. aFollow-up visits at Days 30, 60, and 100 ( ±7 days) should occur after the last dose or on the date of discontinuation ( ±7 days) . bExcept for participants who start new anti-cancer therapies, participants with SD, PR, or CR at the EOT visit should undergo tumor assessment via CT/MRI scans at least Q12W during the survival follow-up period until progression. Abbreviations: ADA = anti-drug antibody; AE = adverse event; CBC = complete blood count; CR = complete response; ECOG = Eastern Cooperative Oncology Group; EOT = end of treatment; FU = follow-up; PE = physical examination; PK = pharmacokinetic; PD = pharmacod ynamic; PR = partial response; Q12W = every 12 weeks; SAE = serious adverse event; SD = stable disease. Revised Protocol No.: 04 Date: 31-May-2019 37 Approved 5.0 v Approved 1.0 v Clinical Protocol CA021002 BMS-986226 anti-ICOS In the event of multiple procedures are required at a single time point, the ECG may be obtained up to 15 minutes earlier, vital signs may be obtained up to 10 minutes earlier or later, and clinical laboratory sample may be obtained up to 5 minu tes earlier than the nominal time point, ensuring the PK samples can be collected on time. 3 INTRODUCTION CA021002 is a Phase 1/2, first-in-human (FIH), ascending, multiple-dose study of BMS-986226, an Inducible T-cell - COStimulator (ICOS; cluster of differentiation [CD]278) agonist monoclonal antibody (mAb), in humans with advanced/metastatic solid tumors as monotherapy or in combination with either nivolumab (programme d death 1 [PD-1] receptor blocking mAb) or ipilimumab (cytotoxic T lymphocyte-associated anti gen-4 [CTLA-4], an activ ation-indu ced T-cell surface molecule that binds CD80 and CD86). This study will evaluate the safety profile, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of intravenous (IV) doses of BMS-986226 administered as monotherapy or in combination with either nivolumab or ipilimumab in participants with advanced solid tumors, including but not limited to, cervical cancer (CC), colorectal cancer (CRC), head and neck squamous cell carcinoma (HNSCC), melanoma (M EL), non-small cell lung cancer (NSCLC), adenocarcinoma of the prostate (PRC), renal cell car cinoma (RCC), triple negative breast cancer (TNBC) and urothelial carcinoma (UCC). 3.1 Study Rationale Antibody-based therapy for cancer has become established in recent years and is now one of the most successful and important strategies for treating patients with hematological malignancies and advanced solid tumors.