NCI Protocol #: CITN12 -03 Version Date: July 26, 2017 1 NCI Protocol #: CITN12 -03 Local Protocol #: CITN12 -03 TITLE: A Phase 2 Study of recombinant glycosylated human interleukin -7 (CYT107) after completion of standard FDA approved therapy with sipuleucel -T (Provenge®) for patients with asymptomatic or minimally symptomatic metastatic castration -resistant prostate cancer (mCRPC) Coordinating Center: Cancer Immunotherapy Trials Network, Fred Hutchinson Cancer Research Center Principal Investigator: Lawrence Fong, M.D. University of California San Francisco Dept. of Medicine (Hematology/Oncology) 513 Parnassus Ave., Room S775, Box 0511 San Francisco, CA 94143 -0511 (415) 514 -3160 (415) 476 -0459 lfong@medicine.ucsf.edu Participating Organizations : CITN – Cancer Immunotherapy Trials Network NCI Protocol #: CITN12 -03 Version Date: July 26, 2017 2 Statistician: Study Coordinator: N/A Bob Salim, PhD Axio Research, LLC 2601, 4th Avenue, Suite 200 Seattle, WA 98121 (206) 577 -0219 bobs@axioresearch.com Responsible Research Nurse: N/A Responsible Data Manager: N/A NCI Supplied Agent : N/A Other Agents : Recombinant Glycosylated Human Int erleukin -7 (CYT107) NSC #767713 IND Sponsor : Martin A. “Mac” Cheever, M.D., IND# 124199 Protocol Type / Version # / Version Date: Amendment # 7/Version 1.0/July 26, 2017 To submit site registration documents: For patient enrollments: Submit study data to: CTSU Regulatory Office 1818 Market Street, Suite 1100 Philadelphia, PA 19103 Phone – 1-866-651-CTSU Fax – 215-569-0206 Please refer to the patient enrollment section for instructions on using the OPEN system or you may access the OPEN system at: https://www.ctsu.org/OPEN_SYSTEM/ Or https://OPEN.ctsu.org For problems using OPEN https://www.ctsu.org/CTSUCOntact.aspx Data collection for this study will be done via Medidata Rave (FHCRC/AXIO Research, Inc.) Please refer to the data submission section of the protocol for Medidata Rave instructions. The current version of the study protocol and all supporting documents must be downloaded from the protocol -specific Web page of the CTSU Member Web site located at https://www.ctsu.org . Access to the CTSU members’ website is managed through the Cancer Therapy and Evaluation Program - Identity and Access Management (CTEP -IAM) registration system and requires user log on with CTEP -IAM username and password. Permission to view and download this protocol and its support ing documents is restricted and is based on person and site roster assignment housed in the CTSU RSS. For patient eligibility or treatment -related questions: Contact the CITN Central Operations and Statistical Center at: 206-667-6609 or email mailto: citn@fhcrc.org For questions unrelated to patient eligibility, treatment, or data submission contact the CTSU Help Desk by phone or e -mail: CTSU General Information Line – 1-888-823-5923, or ctsucontact@westat.com . All calls and correspondence will be triaged to the appropriate CTSU representative. The CTSU Web site is located at https://www.ctsu.org NCI Protocol #: CITN12 -03 Version Date: July 26, 2017 3 Treatment Schema Cohort CYT107 Dose Frequency 1 - Observation No CYT107 dose -------- 2 - CYT107 10 μg/kg Days 0, 7 , 14 and 21 NCI Protocol #: CITN12 -03 Version Date: July 26, 2017 4 TABLE OF CONTENTS 1. OBJECTIVES ................................