Alternative care options will be discussed with the participant. When a participant is removed from protocol therapy and/or is off of the study, the relevant Off-Treatment/Off- Study information will be updated in OnCore. 5.15 Criteria for Taking a Participant Off Study Participants will be removed from study when any of the following criteria apply:  Lost to follow-up  Withdrawal of consent for data submission  Death  Disease progression by IMWG criteria, prior to the administration of study treatment The reason for taking a participant off study, and the date the participant was removed, must be documented in the case report form (CRF). In addition, the study team will ensure Off Treatment/Off Study information is updated in OnCore in accordance with DF/HCC policy REGIST-101.