................................ .....85 Table 13. Safety Laboratory Tests ............................................................................92 Table 14. Requirements for Recording Safet y Events on the Case Report Form (CRF) and Reporting Safety Events on the Clinical Trial Serious Adverse Events Form ................................................................104 Table 15. Clinical Description of Severit y .............................................................111 Table 16. Medication Errors Reporting on the Clinical Trial Serious Adverse Event Form .............................................................................................115 Table 17. Objective Response Status at each Evaluation ................................ .......154 Table 18. Objective Response Status at each Evaluation for Participants with Non-Target Disease Only .......................................................................154 PF-06936308 C3621001 Final Protocol Amendment 2, 22 Dec 2020 PFIZER CONFIDENTIAL Page 13LIST OF FIGURES Figure 1. Study Design .............................................................................................61 Figure 2. Cardiac Safety Monitoring Algorithm ......................................................96 APPENDICES Appendix 1. Abbreviations ....................................................................................................142 Appendix 2. ECOG Performance Status ................................................................................149 Appendix 3. RECI ST (Response Evaluation Criteria In Solid Tumors) version 1.1Guidelines .........................................................................................150 Appe ndix 4. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) ......................................................................155 Appendix 5. Management of Immune - related Adverse Events (irAEs)................................156 Appendix 6. Recommended Management Algorithm for Myasthenia Gravis ......................162 Appendix 7.Alternative Measures During Public Emergencies ...........................................163 PF-06936308 C3621001Final Protocol Amendment 2, 22 Dec 2020 PFIZER CONFIDENTIAL Page 14SCHEDULE OF ACTIVITIES The schedule of activities table provides an overview of the protocol visits and procedures. Refer to the ASSESSMENTS section of the protocol for detailed information on each assessment required for compliance with the protocol. The investigator may schedule visits (unplanned visits) in addition to those listed in the schedule of activities table in order to conduct evaluations or assessments required to protect the well-being of the participant. SCHEDULE OF ACTIVITIES FOR DOSE ESCALATION (PART 1) Protocol Activity Screen 1 (£28 days)Treatment Period Post Treatment Cycle 1 Cycle 2 End of Treatment 33Follow- Up (Months after EOT visit)Survival Follow-up35 Study Day Day 1Day 8Day 15Day 22Day 29Day 43Day 57Day 71Day 85Day 113Month 134Month 2 Month 4 Month 6 Post 6-Month Follow-up Cycle Day Day 1Da y 29Day 57Da y 85Day 9928 to 35 daysEvery 3 Months Visit Window (Days) *±1 ±2 ±2 ±2 ±4 ±2 ±4 ±2 ±2 ±2 ±2 ±2 ±4 ±4 ±4 ±4 ±10 Informed consent2X Tumor histor y3X Medical histor y7X Complete physical examination8XX Abbreviated physical examination 8X X X X XXXXX X X X X Assessment of skin thickness at administration sites 9XCCI PF-06936308 C3621001 Final Protocol Amendment 2, 22 Dec 2020 PFIZER CONFIDENTIAL Page 15Protocol Activity Screen 1 (£28 days)Treat ment Period Post Treat ment Cycle 1 Cycle 2 End of Treat ment 33Follow -Up (Months after EOT visit)Survival Follow -up35 Study Day Day 1Day 8Day 15Day 22Day 29Day 43Day 57Day 71Day 85Day 113Month 134Month 2 Month 4 Month 6 Post 6 -Month Follow -up Cycle Day Day 1Da y 29Day 57Da y 85Day 9928 to 35 daysEvery 3 Months Visit Window (Days) *±1 ±2 ±2 ±2 ±4 ±2 ±4 ±2 ±2 ±2 ±2 ±2 ±4 ±4 ±4 ±4 ±10 Height X Weight X X X X Vital signs10X X X X X X X X X X X X X X X X X Performance status11X X X X X X X X X X X X X X Laboratory Unique Screening Labs12X Hematology13X X X X X X X X X X X X X X X X X X X X Blood Chemistry14X X X X X X X X X X X X X X X X X X X X Coagulation15X X X X X X X Cardiac Troponin -I (cTnI)16X X X X X Urinalysis17X X X X X X X X X X X Pregnancy Test or FSH Level (Serum)18X X X X X X X X X X X Contraception Check19X X X X X X X X X X X X X X (12 lead) ECG20X X X X X X X Registration Registration21X Study Treat ment Adenovirus (AdC68) administration22 Refer to Part 1 Schedule of Study Treatment, Pharmacokinetics and Immunogenicity Assessments Plasmid DNA (pDNA) administration22 PF-06936308 C3621001Final Protocol Amendment 2, 22 Dec 2020 PFIZER CONFIDENTIAL Page 16Protocol Activity Screen 1 (£28 days)Treatment Period Post Treatment Cycle 1 Cycle 2 End of Treatment 33Follow- Up (Months after EOT visit)Survival Follow-up35 Study Day Day 1Day 8Day 15Day 22Day 29Day 43Day 57Day 71Day 85Day 113Month 134Month 2 Month 4 Month 6 Post 6-Month Follow-up Cycle Day Day 1Da y 29Day 57Da y 85Day 9928 to 35 daysEvery 3 Months Visit Window (Days) *±1 ±2 ±2 ±2 ±4 ±2 ±4 ±2 ±2 ±2 ±2 ±2 ±4 ±4 ±4 ±4 ±10 Tremelimumab administration –For cohorts assigned to receive tremelimumab 22 Sasanlimab administration –For cohorts assigned to receive sasanlimab 22 Tumor Assessment CT scan, MRI scan or bone scan23X Performed every 8 weeks up to Week 3223 Other samplings AChR antibod y25X ER, PR, HER2 Status 30X Pharmacokinetics and Tremelimumab ADARefer to Part 1 Schedule of Study Treatment, Pharmacokinetics and Immunogenicity AssessmentsCCI CCI PF-06936308 C3621001Final Protocol Amendment 2, 22 Dec 2020 PFIZER CONFIDENTIAL Page 17Protocol Activity Screen 1 (£28 days)Treatment Period Post Treatment Cycle 1 Cycle 2 End of Treatment 33Follow- Up (Months after EOT visit)Survival Follow-up35 Study Day Day 1Day 8Day 15Day 22Day 29Day 43Day 57Day 71Day 85Day 113Month 134Month 2 Month 4 Month 6 Post 6-Month Follow-up Cycle Day Day 1Da y 29Day 57Da y 85Day 9928 to 35 daysEvery 3 Months Visit Window (Days) *±1 ±2 ±2 ±2 ±4 ±2 ±4 ±2 ±2 ±2 ±2 ±2 ±4 ±4 ±4 ±4 ±10 Pharmacokinetics and SasanlimabADA Other clinical assessments Serious and non-serious adverse event monitoring 31X Concomitant medications and non-drug supportive interventions 32XXXXXXXXXXXXX X X X X X X Survival Follow-up35X * Visit windows during the treatment period are to be calculated based on the previous dosing visit. Abbreviations : Ĭ= ongoing; AChR = acetylcholine receptor; ADA = anti-drug antibodies; AdC68= Adenovirus; AE = adverse events; CRP= C-Reactive P rotein; CT = computed tomography; ; ECG = electrocardiogram ;EOT = End of Treatment; ER = estrogen receptors; HER2 = human epidermal growth factor receptor 2; hsCRP=high sensitivity C-reactive protein; MRI = magnetic resonance imaging; MSLN = mesothelin; MUGA = multiga ted acquisition scan; PBMC = peripheral blood mononuclear cell; pDNA=plasmid deoxyribonucleic acid; PR = progesterone receptors; (X)=Optional 1. Screening: To be obtained within 28 days prior to study entry.