• At the time of publication or shortly thereafter. 6.2.2 Genomic Data Sharing Plan Unlinked genomic data will be deposited in public genomic databases such as dbGaP in compliance with the NIH Genomic Data Sharing Policy . 6.3 R ESPONSE CRITERIA 6.3.1 Antitumor Response Tumor assessments may include the following evaluations: physical examination (with photograph and measurement of skin lesions, as applicable); cross -sectional imaging using computed tomography (CT) or magnetic resonance imaging (MRI) scan of the chest, abdomen, and pelvis (pelvis scan is optional unless known pelvic disease is present at baseline); nuclear bone scan for subjects with known/suspected bone lesions; and CT or MRI scan of the brain (only as clinically warranted based on symptoms/findings). The preferred method of disease assessment is CT with 62 Abbreviated Title: Combo Immunotx in HPV Cancers Version Date: 05.12.2023 contrast. If CT with contrast is contraindicated, CT of the chest without contrast and MRI scan of the abdomen/pelvis is preferred. At baseline, tumor lesions will be selected and categorized as target or non -target lesions. Target lesions include those lesions that can be accurately measured in at least 1 dimension as ≥ 20 mm with conventional techniques or ≥ 10 mm with CT scan. Malignant lymph nodes with a short axis diameter ≥ 15 mm can be considered target lesions. Up to a maximum of 2 target lesions per organ and 5 target lesions in total will be identified at baseline. These lesions should be representative of all involved organs and selected based on their size (those with the longest diameter) and their suitability for accurate repeated measurements. A sum of the longest lesion diameter (LLD) for all target lesions will be calculated and reported as the baseline sum LLD. For malignant lymph nodes identified as target lesions, the short axis diameter will be used in the sum of LLD calculation. All other lesions (or sites of disease) should be identified as non- target lesions (including bone lesions). All post -baseline response assessments should follow the same lesions identified at baseline. The same mode of assessment (e.g., CT) used to identify/evaluate lesions at baseline should be used throughout the course of the study unless subject safety neces sitates a change (e.g., allergic reaction to contrast media). For the primary endpoint antitumor activity will be evaluated with target and/or non- target lesions according to RECIST Version 1.1. 6.3.2 Disease Parameters Measurable disease: Measu rable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as: • By chest x -ray: > 20 m m; • By CT scan: o Scan slice thickness 5 mm or under: as > 10 mm o Scan slice thickness > 5 mm: double the slice thickness • With calipers on clinical exam: > 10 mm. All tumor measurements must be recorded in millimeters (or decimal fractions of centimeters). Malignant lymph nodes. To be considered pathologically enlarged and measurable, a lymph node must be > 15 mm in short axis when assessed by CT scan (CT scan slice thickness recommended to be no greater than 5 mm). At baseline and in follow -up, only the short axis will be measured and followed. Non-measurable disease. All ot her lesions (or sites of disease), including small lesions (longest diameter < 10 mm or pathological lymph nodes with ≥ 10 to < 15 mm short axis), are considered non-measurable disease. Bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusions, lymphangitis cutis/pulmonitis, inflammatory breast disease, and abdominal masses (not followed by CT or MRI), are considered as non- measurable. 63 Abbreviated Title: Combo Immunotx in HPV Cancers Version Date: 05.12.2023 Note: Cystic lesions that meet the criteria for radiographically defined simple cysts should not be considered as malignant lesions (neither measurable nor non- measurable) since they are, by definition, simple cysts. ‘Cystic lesions’ thought to represent cystic metastases can be considered as measurable lesions, if they meet the definition of measurability described above. However, if non- cystic lesions are present in the same participant, these are preferred for selection as target lesions. Target lesions. All m easurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as target lesions and recorded and measured at baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter), be representative of all involved organs, but in addition should be those that lend themselves to reproducible repeated measurements. It may be the case that, on occasion, the largest lesion does not lend itself to reproducible measurement in which circumstance the next largest lesion which can be measured reproducibly should be selected. A sum of the diameters (longest for non -nodal lesions, short axis for nodal lesions) for all target lesions will be calculated and reported as the baseline sum diameters. If lymph nodes are to be included in the sum, then only the short axis is added into the sum. The baseline sum diameters will be used as reference to further characterize any objective tumor regr ession in the measurable dimension of the disease. Non-target lesions . All o ther lesions (or sites of disease) including any measurable lesions over and above the 5 target lesions should be identified as non- target lesions and should also be recorded at baseline. Measurements of these lesions are not required, but the presence, absence, or in rare cases unequivocal progression of each should be noted throughout follow-up. 6.3.3 Methods for Evaluation of Measurable Disease All measurements should be taken and recorded in metric notation using a ruler or calipers. All baseline evaluations should be performed as closely as possible to the beginning of treatment and never more than 4 weeks before the beginning of the treatment. 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. Imaging- based evaluation is preferred to evaluation by clinical examination unless the lesion(s) being followed cannot be imaged but are assessable by clinical exam. Clinical lesions : Clini cal lesions will only be considered measurable when they are superficial (e.g., skin nodules and palpable lymph nodes) and ≥ 10 mm diameter as assessed using calipers (e.g., skin nodules). In the case of skin les ions, documentation by color photography, including a ruler to estimate the size of the lesion, is recommended. Chest x -ray: Lesi ons on chest x- ray are acceptable as measurable lesions when they are clearly defined and surrounded by aerated lung. Howeve r, CT is preferable. Conventional CT and MRI: This gui deline has defined measurability of lesions on CT scan based on the assumption that CT slice thickness is 5 mm or less. If CT scans have slice thickness greater than 5 mm, the minimum size for a measurable lesion should be twice the slice thickness. MRI is also acceptable in certain situations (e.g.