10.4.9 Analysis of exploratory objectives. The following endpoints will be evaluated: Immune infiltrate by flow cytometry and localization using multiplex immunofluorescence  T cell clonality using Deep TCRseq TIL responses to shared antigens and antigens predicted from exome and RNA sequencing Antigen specific responses using peripheral T cell isolation Multiparameter characterization of PBMC by flow cytometry Changes in serum cytokines Changes in TGF signaling in tumor, normal mucosa and skin These evaluations may result in descriptive statistics or possibly statistical evaluations of effects. If any statistical tests are performed, they will be conducted in an exploratory fashion, without any adjustment for multiple testing performed but interpreted in the context of the number of tests undertaken. 11 COLLABORATIVE AGREEMENTS 11.1 COOPERATIVE R ESEARCH AND DEVELOPMENT AGREEMENT (CRADA) A CRADA (02666) is in place with EMD Serono for the supply of M7824. A CRADA (03058) is in place with ImmunityBio (previously NantCell) for the supply of N-803. A CRADA (02997) is in place with ImmunityBio (previously NantCell) for the supply of ETBX (TriAd) vaccines 12 HUMAN SUBJECTS PROTECTIONS 12.1 RATIONALE F OR S UBJECT SELECTION Subjects from all racial/ethnic groups and both genders are eligible for this study if they meet the eligibility criteria. Efforts will be made to extend accrual to a representative population, but in this preliminary study, a balance must be struck between patient safety considerations and limitations on the number of individuals exposed to potentially toxic and/or ineffective treatments on one hand and the need to explore gender and ethnic aspects of clinical research on the other hand.