14.5.2 Pembrolizumab Pembrolizumab may be requested by the Principal Investigator (or their authorized designees) at each participating institution. All regulatory document requirements, as described in the BTTC Operations Manual, must be current and up to date in the BTTC Coordinating Center. A Study Drug Order Form and Pharmacy Initiation Worksheet Form will need to be completed; these forms can be obtained from the BTTC Coordinating Center. The participating institution must have received a Site Activation Memo from the BTTC Coordinating Center prior to requesting study agents. Signed and Dated drug requests should be emailed to: Merck Attn: Eleonora Veglia, PhD Email: nciisdrugorder@merck.com Cc: eleonora.veglia@msd.com Phone: +44 (0) 7824524450 When a number of investigators are participating on a clinical study at the same institution, one investigator should be considered or designated the principal or lead investigator under whom all investigational agents for that protocol should be ordered. 14.5.3 Temozolomide Temozolomide is commercially available. 14.5.4 Agent Storage and Accountability: The investigator is responsible for the proper and secure physical storage and record keeping of investigational agents received for BTTC protocols. Specifically, the investigator must: 104 Abbreviated Title: GBM Pembro HSPPC Version Date: 03/26/2024 oMaintain a careful record of the receipt, use and final disposition of all investigational agents received, using the NCI Investigational Agent Accountability Record Form (DARF), http://ctep.cancer.gov/forms/index.html oStore the agent in a secure location, accessible to only authorized personnel, preferably in the pharmacy. oMaintain appropriate storage of the investigational agent to ensure the stability and integrity of the agent. oReturn or destroy any unused investigational agents at the completion of the study or upon notification that an agent is being withdrawn. The intent of the agent accountability procedures described in this section is to assist the investigator in making certain that agents received from BTTC are used only for patients entered onto an approved protocol. The record keeping described in this section is required under FDA regulation. Investigators are responsible for the use of investigational agents shipped in their name. Even if a pharmacist or chemotherapy nurse has the actual task of handling these agents upon receipt, the investigator is the responsible individual and has agreed to accept this responsibility by signing the FDA 1572: https://www.fda.gov/science-research/clinical-trials- and-human-subject-protection/clinical-trial-forms 14.5.5 BTTC Procedures for Agent Accountability and Storage oEach investigational agent should be stored separately by protocol. If an agent is used for more than one protocol, there should be separate physical storage for each protocol.