2 Ambulatory and capable of all self -care but unable to carry out an y work activities. Up and about more than 50% of waking hours. 3 Capable of onl y limited self -care, confined to bed or chair more than 50% of waking hours. 4 Completely disabled. Cannot carry on any self-care. Totall y confined to bed or chair. 5 Dead. *As published in Am J Clin Oncol 5:649 655, 1982 PF-06936308 C3621001 Final Protocol Amendment 2, 22 Dec 2020 PFIZER CONFIDENTIAL Page 150Appendix 3. RECIST (Response Evaluation Criteria In Solid Tumors) version 1.1Guidelines Adapted from E.A. Eisenhauer, et al: New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1). European Journal of Cancer 45 (2009) 228 –247. CATEGORIZING LESIONS AT BASELINE Measurable Lesions Lesions that can be accurate ly measured in at least one dimension. Lesions with longest diameter twice the slice thickness and at least 10 mm or greater when assessed b y CT or MRI (slice thickness 5-8 mm). Lesions with longest diameter at least 20 mm when assessed by Chest X -ray. Superficial lesions with longest diameter 10 mm or greater when assessed by caliper. Malignant l ymph nodes with the short axis 15 mm or greater when assessed by CT. NOTE: The shortest axis is used as the diameter for malignant lymph nodes, longest axis for all other measurable lesions. Non-measurable disease Non-measurable disease includes lesions too small to be considered measurable (including nodes with short axis between 10 and 14.9 mm) and truly non-measurable disease such as pleural or pericardial ef fusions, ascites, inflammatory breast disease, leptomeningeal disease, lymphangitic involvement of skin or lung, clinical lesions that cannot be accurately measured with calipers, abdominal masses identified b y physical exam that are not measurable b y reproducible imaging techniques. Bone disease: Bone disease is non -measurable with the exception of soft tissue components that can be evaluated b y CT or MRI and meet the definition of measurability at baseline. Previous local treatment: A previously irradiate d lesion (or lesion subjected to other local treatment) is non -measurable unless it has progressed since completion of treatment. Normal sites Cystic lesions: Simple cysts should not be considered as malignant lesions and should not be recorded either as t arget or non- target disease. Cy stic lesions thought to represent cy stic metastases can be measurable lesions, if they meet the specific definition above. If non -cystic lesions are also present, these are preferred as target lesions. PF-06936308 C3621001 Final Protocol Amendment 2, 22 Dec 2020 PFIZER CONFIDENTIAL Page 151Normal nodes: Nodes w ith short axis <10 mm are considered normal and should not be recorded or followed either as measurable or non -measurable disease. Recording Tumor Assessments All sites of disease must be assessed at baseline. Baseline assessments should be done as close as possible prior to study start. For an adequate baseline assessment, all required scans must be done within 28 days prior to treatment and all disease must be documented appropriatel y. If baseline assessment is inadequate, subsequent statuses generall y should be indeterminate. Target lesions All measurable lesions up to a maximum of 2 lesions per organ, 5 lesions in total, representative of all involved organs, should be identified as target lesions at baseline. Target lesions should be selected on t he basis of size (longest lesions) and suitability for accurate repeated measurements. Record the longest diameter for each lesion, except in the case of pathological l ymph nodes for which the short axis should be recorded. The sum of the diameters (long est for non-nodal lesions, short axis for nodal lesions) for all target lesions at baseline will be the basis for comparison to assessments performed on study . If two target lesions coalesce the measurement of the coalesced mass is used. If a large targe t lesion splits, the sum of the parts is used. Measurements for target lesions that become small should continue to be recorded. If a target lesion becomes too small to measure, 0 mm should be recorded if the lesion is considered to have disappeared; othe rwise a default value of 5 mm should be recorded. NOTE: When nodal lesions decrease to <10 mm (normal), the actual measurement should still be recorded. Non-target disease All non-measurable disease is non- target. All measurable lesions not identified as target lesions are also included as non -target disease. Measurements are not required but rather assessments will be expressed as ABSENT, INDETERMI NATE, PRESENT/NOT INCREASED, INCREASED. Multiple non- target lesions in one organ may be recorded as a single item on the case report form (eg, ‘multiple enlarged pelvic l ymph nodes’ or ‘multiple liver metastases’). PF-06936308 C3621001 Final Protocol Amendment 2, 22 Dec 2020 PFIZER CONFIDENTIAL Page 152OBJECTIVE RESPONSE S TATUS AT EACH EVALUA TION Disease sites must be assessed using the same technique as baseline, including consistent administration of contrast and timing of scanning. I f a change needs to be made the case must be discussed with the radiologist to determine if substitution is possible. If not, subsequent objective statuses are indeterminate. Targe t disease Complete Response (CR): Complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis <10mm). All target lesions must be assessed. Partial Response (PR): Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other targe t lesions. All target lesions must be assessed. Stable: Does not qualify for CR, PR or Progression. All target lesions must be assessed. Stable can follow PR only in the rare case that the sum increases by less than 20% from the nadir, but enough that a previously documented 30% decrease no longer holds. Objective Progression (PD): 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therap y), with a minimum absolute increase of 5 mm. Indeterminate. Progression has not been documented, and one or more target measurable lesions have not been assessed; or assessment methods used were inconsistent with those used at baseline; or one or more target l esions cannot be measured accuratel y (eg, poorl y visible unless due to being too small to measure); or one or more target lesions were excised or irradiated and have not reappeared or increased. Non-target disease CR: Disappearance of all non- target lesio ns and normalization of tumor marker levels. All ly mph nodes must be ‘normal’ in size (<10 mm short axis). Non-CR/Non -PD: Persistence of an y non -target lesions and/or tumor marker level above the normal limits. PF-06936308 C3621001 Final Protocol Amendment 2, 22 Dec 2020 PFIZER CONFIDENTIAL Page 153PD: Unequivocal progression of pre- existing lesions. Generally the overall tumor burden must increase sufficiently to merit discontinuation of therapy . In the presence of stable disease (SD) or PR in target disease, progression due to unequivocal increase in non -target disease should be rare. Indeterminate: Progression has not been determined and one or more non -target sites were not assessed or assessment methods were inconsistent with those used at baseline. New Lesions The appearance of an y new unequivocal malignant lesion indicates PD. If a new lesion is equivocal, for example due to its small size, continued assessment will clarify the etiology . If repeat assessments confirm the lesion, then progression should be recorded on the date of the initial assessment. A lesion identified in an ar ea not previously scanned will be considered a new lesion. Supplemental Investigations If CR determination depends on a residual lesion that decreased in size but did not disappear completel y, it is recommended the residual lesion be investigated with biopsy or fine needle aspirate. If no disease is identified, objective status is CR. If progression determination depends on a lesion with an increase possibly due to necrosis, the lesion may be investigated with biopsy or fine needle aspirate to clarify status. Subjective progression Participants requiring discontinuation of treatment without objective evidence of disease progression should not be reported as PD on tumor assessment CRFs. This should be indicated on the end of treatment CRF as off treatment due to Global Deterioration of Health Status. Every effort should be made to document objective progression even after discontinuation of treatment. PF-06936308 C3621001 Final Protocol Amendment 2, 22 Dec 2020 PFIZER CONFIDENTIAL Page 154Table 17. Objective Response Status at each Evaluation Target Lesions Non-target Disease New Lesions Objective status CR CR No CR CR Non-CR/Non -PD No PR CR Indeterminate or Missing No PR PR Non-CR/Non -PD, Indeterminate, or MissingNo PR SD Non-CR/Non -PD, Indeterminate, or MissingNo Stable Indeterminate or MissingNon-PD No Indeterminate PD Any Yes or No PD Any PD Yes or No PD Any Any Yes PD Table 18.Objective Response Status at each Evaluation for Participants with Non-Target Disease Only Non-target Disease New Lesions Objective status CR No CR Non-CR/Non -PD No Non-CR/Non -PD Indeterminate No Indeterminate Unequivocal progression Yes or No PD Any Yes PD PF-06936308 C3621001 Final Protocol Amendment 2, 22 Dec 2020 PFIZER CONFIDENTIAL Page 155Appendix 4. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) The NCI CTCAE (Version 5.0 dated November 27, 2017) has been placed in the Study Manual for this protocol. Alternativel y, the NCI CTCAE may be reviewed on -line at the following NCI website: https://ctep.cancer.gov/protocoldevelopment/electronic_applications/ctc.htm PF-06936308 C3621001 Final Protocol Amendment 2, 22 Dec 2020 PFIZER CONFIDENTIAL Page 156Appendix 5. Management of Immune-related Adver se Events (irAEs) Management of irAEs including M yasthenia Gravis Gastrointestinal irAEs Severity ofDiarrhea/Colitis (NCI - CTCAE v5.0)Initial Managem ent Follow -up Managem ent Grade 1 Diarrhea: <4stools/day over Baseline Colitis: asymptomatic-Continue study treatment. -Symptomatic treatment (eg, loperamide).-Close monitoring for w orsening symptoms.