-Pulmonary and Infectious Disease consults. -1.0 to 2.0 mg/kg/day prednisone or equivalent. -Add prophylactic antibiotics for opportunistic infections. -Consider bronchoscopy, lung biopsy.If improves to Grade ≤1: -Taper steroids over at least 1 month. -If not improving after 48 hours or worsening: Add additional immunosuppression (for example, infliximab, cyclophosphamide, IV. -immunoglobulin, or mycophenolate mofetil). PF-06936308 C3621001 Final Protocol Amendment 2, 22 Dec 2020 PFIZER CONFIDENTIAL Page 159Hepatic irAEs Grade of Liver Test Elevation (NCI -CTCAE v5.0)Initial Managem ent Follow -up Managem ent Grade 1 Grade 1AST orALT >ULN to3.0xULN and/or Total bilirubin >ULN to 1.5 xULN-Continue study treatment. -Continue liver function monitoring. -If worsens: Treat as Grade 2or3 -4. Grade 2 AST orALT >3.0 to≤ 5 xULN and/or total bilirubin >1.5 to ≤ 3x ULN-Withhold study treatment. -Increase frequency ofmonitoring to every 3 days.-If returns to Grade ≤1: -Resume routine monitoring; resume study treatment. -If elevation persists >5 to 7 days or worsens: -Treat as Grade 3 to 4. Grade 3to 4 AST or ALT >5xULN and/or total bilirubin >3 xULN-Perm anently discontinue study treatment. -Increase frequency of monitoring to every 1 to 2 days. -1.0 to 2.0 mg/kg/day prednisone or equivalent. -Add prophylactic antibiotics for opportunistic infections. -Consult gastroenterologist/hepatologist. -Consider obtaining M RI/CT scan of liver and liver biopsy if clinically warranted.-If returns to Grade ≤1: -Taper steroids over at least 1 month. -If does not improve in >3 to 5 days, worsens or rebounds: -Add mycophenolate mofetil 1 gram (g) twice daily. -If no response with in an additional 3 to 5 days, consider other immunosuppressants per local guidelines. PF-06936308 C3621001 Final Protocol Amendment 2, 22 Dec 2020 PFIZER CONFIDENTIAL Page 160Renal irAEs Grade of Creatinine Increased (NCI -CTCAE v5.0)Initial Managem ent Follow -up Managem ent Grade 1 Creatinine increased >ULN to1.5x ULN-Continue study treatment.-Continue renal function monitoring -If worsens: Treat as Grade 2 to 3 or 4. Grade 2 to 3 Creatinine increased >1.5 and ≤6 x ULN-Withhold study treatment. -Increase frequency of monitoring to every 3 days. -1.0 to 2.0 mg/kg/day prednisone or equivalent. -Add prophylactic antibiotics for opportunistic infections. -Consider renal biopsy.-If returns to Grade ≤1: -Taper steroids over at least 1 month, and resume study treatment following steroids taper. -If worsens: -Treat as Grade 4. Grade 4 Creatinine increased >6 x ULN-Perm anently discontinue study treatment. -Monitor creatinine daily. -1.0 to 2.0 mg/kg/day prednisone or equivalent. -Add prophylactic antibiotics for opportunistic infections Consider renal biopsy. -Nephrology consult.-Ifreturns to Grade ≤1: Taper steroids over at least 1 month. PF-06936308 C3621001 Final Protocol Amendment 2, 22 Dec 2020 PFIZER CONFIDENTIAL Page 161Cardiac irAEs Myocarditis Initial Managem ent Follow -up Managem ent New onset of cardiac signs or symptoms and / or new laboratory cardiac biomarker elevations (eg, troponin, CK -MB, BNP) or cardiac imaging abnormalities suggestive of myocarditis.-Withhold study treatment. -Hospitalize. -In the presence of life threatening cardiac decompensation, consider transfer to a facility experienced in advanced heart failure and arrhythmia management. -Consult cardiologist to establish etiology and rule -out immune -mediated myocarditis. -Guideline based supportive treatment as per cardiology consult.* -Consider myocardial biopsy if recommended per cardiology consult.-If symptoms improve and immune -mediated etiology is ruled out, re- start study treatment. -If symptoms do not improve/worsen, viral myocarditis is excluded, and immune -mediated etiology is suspected or confirmed following cardiology consult, manage as immune - mediated myocarditis. Immune -mediated myocarditis. -Perm anently discontinue study treatment. -Guideline based supportive treatment as appropriate as per cardiology consult.* 1.0 to 2.0 mg/kg/day prednisone or equivalent. -Add prophylactic antibiotics for opportunistic infectio ns.Once improving, taper steroids over at least 1 month. If no improvement or worsening, consider additional immunosuppressants (eg, azathioprine, cyclosporine A). *Local guidelines, or eg. ESC or AHA guidelines ESC guidelines website: https://www.escardio.org/Guidelines/Clinical -Practice -Guidelines AHA guidelines website: http://professional.heart.org/professional/GuidelinesStatements/UCM_316885_Guidelines -Statements.jsp. PF-06936308 C3621001 Final Protocol Amendment 2, 22 Dec 2020 PFIZER CONFIDENTIAL Page 162Appendix 6.Recommended Management Algorithm for Myasthenia Gravis Recommended Management Algorithm for Myasthenia Gravis (MG) PF-06936308 C3621001 Final Protocol Amendment 2, 22 Dec 2020 PFIZER CONFIDENTIAL Page 163Appendix 7. Alternative Measures During Public Emergencies Thealternative study measures described in this section areto be followed during public emergencies, including the COVID -19 pandemic. This appendix applies for theduration of the COVID -19 pandemic and will become effective for other public emergencies only upon written notification from Pfizer. Use of these alternative study measures are expected to cease upon the return of business as usual circumstances (including the lifting of an y quarantines and travel bans/advisories). Eligibility While SARS -CoV2 testing is not mandated for this study , local clinical practice standards for testing should be followed. A participant should be excluded if he/she has a positive test result for SARS -CoV2 infection, is known to have asy mptomatic infection, or is suspected of having SARS -CoV2. Participants with active infections are excluded from study participation as per exclusion criterion #9 (Part 2) : Active and clinically significant bacterial, fungal or viral infection. When the infection resolves, the participant may be considered for re-screening. Alter native Facilities for Safety Assessments Laboratory Testing If a stud y participant is unable to visit the site for protocol -specified safety laboratory evaluations, testing may beconducted at a local laboratory if permitted by local regulations. The loc al laboratory may be a standalone institution or within a hospital. The safet y laboratory evaluations included in Section 7.1.3 may be performed at a local laborato ry. If a local laboratory is used, qualified stud y site personnel must order, receive, and review results prior to dosing. Site staff must collect thelocal laboratory reference ranges and certifications/accreditations for filing at the site. Laboratory test results are to be provided to the site staff as soon as possible. The local laboratory reports should be filed in the participant’s source documents/medical records. Relevant data from the local laboratory report should be recorded on the CRF. Study Intervention If the safet y of a trial participant is at risk because they cannot complete required evaluations or adhere to critical mitigation steps, then discontinuing that participant from study intervention must be considered. PF-06936308 C3621001 Final Protocol Amendment 2, 22 Dec 2020 PFIZER CONFIDENTIAL Page 164The following is r ecommended for the continued administration of the investigational products for participants who have active confirmed (positive by regulatory authorit y- approved test) or presumed (test pending/clinical suspicion) SARS -CoV2 infection: For s ymptomatic parti cipants with active SARS -CoV2 infection, study intervention should be delay ed for at least 14 day s from the start of sy mptoms. This delay is intended to allow the resolution of sy mptoms of SARS- CoV2 infection. Prior to restarting treatment, the participant should be afebrile for 72 hours, and SARS -CoV2- related s ymptoms should have recovered to ≤ Grade 1 for a minimum of 72 hours. Notify the study team when treatment is restarted. Continue to consider potential drug-drug interactions as described in Section 5.7for any concomitant medication administered for treatment of SARS -CoV2 infection. Adverse Events and Serious Adve rse Events If a participant has COVID -19 during the study , this should be reported as an AE or SAE and appropriate medical intervention provided. Temporary discontinuation of the study intervention may be medically appropriate until the participant has re covered from COVID -19. It is recommended that the investigator discuss temporary or permanent discontinuation of study intervention with the study medical monitor.