Have similar problems occurred on this protocol at your site? ☐ Yes ☐ No Describe what steps you have already taken or will be taking as a result of this problem: INVESTIGATOR’S SIGNATURE: DATE: 128 Abbreviated Title: GBM Pembro HSPPC Version Date: 03/26/2024 16.11 UNBLINDING REQUEST MEMO MEMORANDUM DATE: TO: Lead PI FROM: __________________________MD Phone Number:_____________________________ Email address:______________________________ Site:______________________________________ RE: Patient Unblinding Request for A randomized, double blind phase II trial of Surgery, Radiation Therapy plus Temozolomide and Pembrolizumab with and without HSPPC-96 in newly diagnosed Glioblastoma (GBM) I am requesting the following patient to be unblinded: Subject ID # ________ I am requesting this patient to be unblinded because: ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ _____________________ Thank you, ____________________________ __________________________ Signature of requesting physician Date I have reviewed this request and agree that the circumstances warrant patient unblinding 129 Abbreviated Title: GBM Pembro HSPPC Version Date: 03/26/2024 _______________________ _________________________ Signature of approving MD Date I have reviewed this request but do not agree that the circumstances warrant patient unblinding. The reason I am denying this request is: ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ _____________________ _______________________ _________________________ Signature of disapproving MD Date 130 Abbreviated Title: GBM Pembro HSPPC Version Date: 03/26/2024 16.12 UNBLINDING NOTIFICATION M EMO MEMORANDUM DATE: _______________ TO: __________________________MD Site:_______________________ FROM: Lead PI, MD RE: Patient Unblinding Notification for protocol titled - A randomized, double blind phase II trial of Surgery, Radiation Therapy plus Temozolomide and Pembrolizumab with and without HSPPC-96 in newly diagnosed Glioblastoma (GBM) With concurrence from the Data Safety Monitoring Board, the Lead PI MD has requested unblinding for the following patient: Subject ID #________ Date of unblinding: _________ The patient’s treatment assignment is: ________HSPPC-96 ________Placebo Be sure to place this memo in the patient’s clinic or hospital chart following your institution’s guidelines. Thank you, _______________________ _______________________ SIGNATURE DATE 131 Abbreviated Title: GBM Pembro HSPPC Version Date: 03/26/2024 16.13 STUDY P HASES AND CORRELATIVE BLOOD DRAWS 132 Abbreviated Title: GBM Pembro HSPPC Version Date: 03/26/2024 16.14 PILL DIARY 133 Abbreviated Title: GBM Pembro HSPPC Version Date: 03/26/2024 134 Abbreviated Title: GBM Pembro HSPPC Version Date: 03/26/2024 16.15 INVESTIGATOR A GREEMENT I have received and reviewed the Investigator Brochure for Pembrolizumab and HSPPC-96. I have read this protocol and agree that the study is ethical.