I nvestigational Product Accountabilit y ...................................................................86 5.6.1. Destruction of Investigational Product Supplies ........................................86 5.7. Concomitant Treatment(s) .......................................................................................87 5.7.1. Prohibited Concomitant Vaccines ..............................................................87 5.7.2. Other Anti -tumor/Anti -Cancer or Experimental Drugs ..............................87 5.7.3. Supportive Care ..........................................................................................87 5.7.4. Hemat opoietic Growth Factors ...................................................................87 5.7.5. Anti -Diarrheal, Anti -Emetic Therap y.........................................................88 5.7.6. Anti -Inflammatory Therap y........................................................................88 5.7.7. Corticosteroids ............................................................................................88 5.7.8. Surgery ........................................................................................................88 6. STUDY PROCEDURES .....................................................................................................88 6.1.Screening .................................................................................................................88 6.2. Study Period ............................................................................................................88 6.3. End of Treatment .....................................................................................................88 6.4. Follow - up ................................................................................................................89 6.5. Survival Follow -up..................................................................................................89 6.6.Participant Withdrawal ............................................................................................89 7. ASS ESSMENTS ..................................................................................................................91 7.1. Safet y Assessment ...................................................................................................91 7.1.1. Pregnancy Testing ......................................................................................91 7.1.2. A dverse Events ...........................................................................................92 7.1.3. L aboratory Safet y Assessment ...................................................................92 7.1.4. Vital Signs and Physical Examination ................................ ........................ 93 7.1.5. (12- Lead) Electrocardiogram ......................................................................94 7.1.6. Monitoring for Potential I mmune Mediated Endocrinopathies .................. 95 7.1.7. Acet ylcholine Receptor Testing .................................................................95 7.1.8. Cardiac Safety Monitori ng .........................................................................95 7.2. Pharmacokinetics Assessments ................................ ................................