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10.6 data management

The Protocol Director, or her designees, will prepare and maintain adequate and accurate participant case histories with observations and other data pertinent to the study. Original source documents should be transcribed to Case Report Forms (CRFs) and used to analyze the study data. Source documents include hospital records, clinical charts, laboratory and pharmacy records, and recorded electronic data. All data required by the trial will be entered onto paper and electronic case report forms. Any corrections to data required into the paper case report forms must be made in such a way that the original entry is not obscured. Only designated study staff will enter data for study participants after study visits. Case report forms will be checked  
 against source document data by study staff. Trial oversight will be carried out by the Protocol Director, Dr. Nooshin Hashemi Sadraei, and her research staff. They will meet weekly to review recently acquired data and adverse events. The data recorded within the research charts and protocol database is compared with the actual data that is available from the medical record and/or clinical histories. Data detailed in the research case report forms includes the nature and severity of all toxicities, which are also reported as described above. All investigators on the protocol will receive formal training in the ethical conduct of human research. Institutional support of trial auditing is provided in accordance with the Cancer Consortium's Data and Safety Monitoring Plan. In addition, protocols are reviewed at least annually by the Scientific Review Committee (SRC) and the Institutional Review Board (IRB).  
| 11.1 ECOG Performance Status Grade                                                                                                                                                                                                                                                                                           | Description                                                                                                                                                    |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 0                                                                                                                                                                                                                                                                                                                            | Normal activity. Fully active, able to carry on all pre-disease  performance without restriction. Symptoms, but ambulatory. Restricted in physically strenuous |
| 1                                                                                                                                                                                                                                                                                                                            | activity, but ambulatory and able to carry out work of a light or  sedentary nature (e.g., light housework, office work). In bed <50% of the time. Ambulatory and capable of all selfcare, but unable to carry out any work activities. Up and about                                                                                                                                                                |
| 2                                                                                                                                                                                                                                                                                                                            | more than 50% of waking hours.                                                                                                                                 |
| 3                                                                                                                                                                                                                                                                                                                            | In bed >50% of the time. Capable of only limited self-care,  confined to bed or chair more than 50% of waking hours.                                           |
| 4                                                                                                                                                                                                                                                                                                                            | 100% bedridden. Completely disabled. Cannot carry on any  self-care. Totally confined to bed or chair.                                                         |
| 5                                                                                                                                                                                                                                                                                                                            | Dead.                                                                                                                                                          |
| *As published in Am. J. Clin. Oncol.: Oken, M.M., Creech, R.H., Tormey, D.C.,  Horton, J., Davis, T.E., McFadden, E.T., Carbone, P.P.: Toxicity And Response  Criteria Of The Eastern Cooperative Oncology Group. Am J Clin Oncol 5:649- 655, 1982. The Eastern Cooperative Oncology Group, Robert Comis M.D.,  Group Chair. |                                                                                                                                                                |
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11.2 common terminology criteria for

The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for adverse event reporting. (http://ctep.cancer.gov/reporting/ctc.html)
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11.3 response evaluation criteria in

RECIST version 1.1* will be used in this study for assessment of tumor response. While either CT or MRI may be utilized, as per RECIST 1.1, CT is the preferred imaging technique in this study. * As published in the European Journal of Cancer:
E.A. Eisenhauer, P. Therasse, J. Bogaerts, L.H. Schwartz, D. Sargent, R. Ford, J. Dancey, S. Arbuck, S. Gwyther, M. Mooney, L. Rubinstein, L. Shankar, L. Dodd, R. Kaplan, D. Lacombe, J. Verweij. New response evaluation criteria in solid tumors:  
 Revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. In addition, volumetric analysis will be explored by central review for response assessment. 11.4 **Events of Clinical Interest Guidance Document** Please refer to section 5.6.1
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11.5 references

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18. Saloura V, Z.Z., Koeppen H, et al. , *T cell-inflamed phenotype correlates with* mesenchymal subtype, expression of PD-L1 and other immune checkpoints in head and neck cancer. J Clin Oncol. , 2014. 32(5s suppl): p. abstr 6009.  
19. Morales-Kastresana, A., et al., *Combined immunostimulatory monoclonal* antibodies extend survival in *an aggressive transgenic hepatocellular* carcinoma mouse model. Clin Cancer Res, 2013. 19(22): p. 6151-62.  
20. Seiwert TY, B.B., Weiss J, et al. , A phase Ib study of MK-3475 in patients with human papillomavirus (HPV)-associated and non-HPV–associated head and neck (H/N) cancer. J Clin Oncol. , 2014. 32(5s ): p. suppl:6011.  
21. Postow, M.A., et al., *Immunologic correlates of the abscopal effect in a patient* with melanoma. N Engl J Med, 2012. 366(10): p. 925-31.