CONTRACEPTION GUIDANCE FOR MALE PARTICIPANTS WITH PARTNER(S) OF CHILD BEARING POTENTIAL. Male participants with female part ners of childbearing potential are eligible to participate if they agree to the following during the treatment and until the end of relevant systemic exposure. •Inform any and all partner(s) of their participation in a clinical drug study and the need to comply with contraception instructions as directed by the investigator. •Male participants are required to use a condom for study duration and until end of relevant systemic exposure defined as 7 months after the end of study treatment. •Female partners of males participating in the study to consider use of effective methods of contraception until the end of relevant systemic exposure, defined as 7 months after the end of treatment in the male participant. •Male participants with a pregnant or breastfeedi ng partner must agree to remain abstinent from penile vaginal intercourse or use a male condo m during each episode of penile penetration during the treatment and until 7 months after the end of study treatment. •Refrain from donating sperm for the duration of the study treatment and until 7 months after the end of study treatment. COLLECTION OF PREGNANCY INFORMATION Guidance for collection of Pregna ncy Information and outcome of pregnancy on the Pregnancy Surveillance Form is provided in Section 9.2.5 and the Appendix for Adverse Events and Serious Adverse Events Definitions and procedur es for Evaluating, Fo llow-up and Reporting. Revised Protocol No.: 04 Date: 31-May-2019 180 Approved 5.0 v Approved 1.0 v Clinical Protocol CA021002 BMS-986226 anti-ICOS APPENDIX 5 RECIST 1.1 CRITERIA 1 ASSESSMENT OF OVERALL TUMOR BURDEN AND MEASURABLE DISEASE To assess objective response or future progression, it is necessary to estimate the overall tumor burden at baseline and use this as a comparator for subsequent measurements. Measurable disease is defined by the presence of at least 1 meas urable tumor lesion. When computed tomographic (CT) scans have slice thickness greater than 5 mm, the minimum size for a measurable lesion should be twice the slice thickness. At baseline, tumor lesions/lymph nodes will be categorized measurable or non-measurable. 1.1 Measurable Lesions Measurable lesions must be accurately measured in at least 1 dimension (l ongest diameter in the plane of the measurement to be recorded) with a minimum size of: •10 mm by computed tomography (CT)/magnetic resonance imaging (MRI) scan (CT/MRI scan slice thickness no greater than 5 mm) •10 mm caliper measurement by clinical examination (lesions that cannot be accurately measured with calipers should be recorded as nonmeasurable) •20 mm by chest X-ray •Malignant lymph nodes : To be considered pathologically enlarged andmeasurable, a lymph node must be ≥15 mm in the short axis when assessed by CT scan (CT scan slice thickness is recommended to be no greater than 5 mm). At baseline and in follow-up, only the short axis will be measured and followed. 1.2 Non-measurable Lesions •All other lesions, including small lesions (l ongest diameter < 10 mm or pathological lymph nodes with ≥10 to < 15 mm short axis), as well as truly non-measurable lesions •Lesions considered truly nonmeasurable include the following: leptomeningeal disease, ascites, pleural or pericardial effusion, inflammatory breast disease, lymphangitic involvement of the skin or lung, and abdominal masses/abdominal organomegaly identified by physical examination that are not measurable by reproducible imaging techniques 1.3 Special Considerations Regarding Lesion Measurability 1.3.1 Bone Lesions •Bone scan, positron emission tomography (PET) scan, or p lain films are notconsidered adequate imaging techniques to measure bone les ions. However, these techniques can be used to confirm the presence or disappearance of bone lesions. •Lytic bone lesions or mixed lytic-blastic lesions, with identifiable soft tissue components that can be evaluated by cross-s ectional imaging techniques such as CT or MRI, can be Revised Protocol No.: 04 Date: 31-May-2019 181 Approved 5.0 v Approved 1.0 v Clinical Protocol CA021002 BMS-986226 anti-ICOS considered as measurable lesions if the soft tissue component meets the definition of measurability described above. •Blastic bone lesions are nonmeasurable. 1.3.2 Cystic Lesions •Lesions that meet the criteria for radiographically defined simple cysts should not be considered malignant lesions (neither measura ble nor nonmea surable) since they are, by definition, simple cysts. •‘Cystic lesions’ thought to represent cystic metastases can be considered measurable lesions if they meet the definition of measurability described above in Section 1.1 . However, if non-cystic lesions are present in the same subject, these are preferred for selection as target lesions. 1.3.3 Lesions with Prior Local Treatment Tumor lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, are usually not considered measurable unless there has been demonstrated progression in the lesion. 1.4 Specifications by Methods of Measurements 1.4.1 Measurement of Lesions All measurements should be recorded in metric notation (mm). All baseline evaluations should be performed as close as possible to the treatment start and never more than 30 days before the beginning of the treatment. 1.4.2 Method of Assessment The same method of assessment and the same technique should be used to characterize each identified and reported lesion at baseline and during follow-up. Unless the lesions being followed cannot be imaged, and are assessable only by clinical examination, imaging-based evaluation should always be done. 1.4.2.1 CT/MRI Scan CT/MRI is the best currently available and reproducible method to meas ure lesions selected for response assessment. Measurability of lesions on CT/MRI scan is based on the assumption that CT/MRI slice thickness is 5 mm or less. When CT scans have slice thickness greater than 5 mm, the minimum size for a measurable lesion should be twice the slice thickness. 1.4.2.2 Chest X-ray Chest CT is preferred over chest X-ray, particularly when progression is an important endpoint, since CT is more sensitive than X-ray, particularly in identifying new lesions. However, lesions on chest X-ray may be considered measurable if they are clearly defined and surrounded by aerated lung. Revised Protocol No.: 04 Date: 31-May-2019 182 Approved 5.0 v Approved 1.0 v Clinical Protocol CA021002 BMS-986226 anti-ICOS 1.4.2.3 Clinical Examination Lesions identified by clinical examination will only be considered measurable when they are superficial and ≥10 mm diameter as assessed using calipers. For the case of skin lesions, documentation by color photography, incl uding a ruler to estimate the s ize of the lesion, is suggested.