For example, death from blood loss could make it difficult to assess other aspects of the investigational immunotherapy’s safety—a primary scientific goal in this early-phase immunotherapy trial, which are carried out in small numbers of participants. 12.2 PARTICIPATION OF C HILDREN Because no dosing or adverse event data are currently available on the use of each individual agent in patients <18 years of age, children are excluded from this study. 12.3 PARTICIPATION OF S UBJECTS UNABLE TO GIVE C ONSENT Adults unable to give consent are excluded from enrolling in the protocol. However, re-consent may be necessary and there is a possibility, though unlikely, that subjects could become decisionally impaired. For this reason and because there is a prospect of direct benefit from research participation (section 12.4), all subjects ≥ age 18 will be offered the opportunity to fill in their wishes for research and care, and assign a substitute decision maker on the “NIH Advance Directive for Health Care and Medical Research Participation” form so that another person can make decisions about their medical care in the event that they become incapacitated or cognitively impaired during the course of the study. Note: The PI or AI will contact the NIH Ability to Consent Assessment Team (ACAT) for evaluation as needed for the following: an independent assessment of whether an individual has the capacity to provide consent; assistance in identifying and assessing an appropriate surrogate when indicated; and/or an assessment of the capacity to appoint a surrogate. For those subjects that become incapacitated and do not have pre-determined substitute decision maker, the procedures described in NIH HRPP Policy 403 for appointing a surrogate decision maker for adult subjects who are (a) decisionally impaired, and (b) who do not have a legal guardian or durable power of attorney, will be followed. 12.4 RISK/BENEFITS A SSESSMENT Patients will receive evaluation of their disease at the National Cancer Institute’s Clinical Center.