SKCN E-Newsletter Volume 9 ISSUE 9 Regional Network Office

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1 SKCN E-Newsletter Volume 9 ISSUE 9 Regional Network Office Clinical Trials at your Fingertips The Jefferson Clinical Trials app allows you to quickly reference the TJU clinical trials database, including access to contact information for all trials. Download the app by searching Jefferson Clinical Trials For more information, Anthony Roberts, BS or Anthony.Roberts@jefferson.edu IN THIS ISSUE Center Stage Clinical Trials App SKCC Featured Trials NCTN Updates Upcoming Events Welcome Kennedy Health Jefferson Health and Kennedy Health are officially ONE. This partnership represents a collaborative and an innovative model for healthcare delivery which will benefit South Jersey residents. Jefferson, Kennedy Health has a well-deserved reputation for their commitment to the communities they serve. This partnership is about bringing expanded and specialized health care to the community so our patients can be conveniently treated close to home. Welcome Kennedy! REFERRING A PATIENT? The SKCN has launched a new referreal address to streamline the process for for working together to provide our patients with personalized oncology treatment care. Please information to clinical-trial-referrals@jefferson.edu

2 Title: Phase IB Trial of Radium-223 and in Patients with Castrate Resistant Prostate Cancer Sponsor: Prostate Cancer Clinical Trials Consortium PI: W. Kevin Kelly, DO Primary Objective: To determine the optimum phase II dose of niraparib when combined with radium-223 in patients with mcrpc that have and have not received prior chemotherapy Treatment: 1 + Radium-223 Dose Finding 100 mg 200 mg Dose Escalation by TITE 300 mg Radium-223 (Xofigo) 55 kbq (1.35 microcurie) per kg body weight, given at 4 week intervals for 6 injections 1 +Radium-223 Dosing at MTD/RP2D MTD/RP2D Radium-223 (Xofigo) 55 kbq (1.35 microcurie) per kg body weight, given at 4 week intervals for 6 injections 1 dosing will continue after 6 cycles of radium-223 until discontinuation criteria are met. Eligibility: Inclusion Criteria Histologic or cytologic diagnosis of adenocarcinoma of the prostate cancer (w/o neuroendocrine differentiation or small cell features. Bone metastases. Documented progressive metastatic CRPC based on at least one of the following criteria: o PSA progression defined as 25% increase over baseline value with an increase in the absolute value of at least 2 ng/ml that is confirmed by another PSA level with a minimum of a 1 week interval and a minimum PSA of 2ng/ ml. o Soft-tissue progression or bone progression. Agree to undergo a tumor/bone marrow biopsy of at least one metastatic site. Have adequate archival prostate cancer tissue for DNA analysis ECOG performance status of 0-2 Must have received at least 1 line of AR-targeted therapy or androgen bio-synthesis inhibitor (e.g., abiraterone acetate, enzalutamide, apalutamide) for PCa. Patients must have adequate organ and marrow function. Washout periods for certain current treatments. Exclusion Criteria: Concurrent treatment with any other investigational therapeutic agents. More than one prior line of chemotherapy at any time. Cannot have ever had platinum-based chemo More than one prior line of therapy with a second generation anti-androgen (enzalutamide, ARN- 509, etc.) or androgen bio-synthesis inhibitor (abiraterone acetate, TAK 700, etc.). Patient may have had one second generation anti-androgen or androgen bio-synthesis inhibitor but not both sequentially. Prior treatment with a PARP inhibitor Prior isotope therapy with Strontium-89, Samarium or RAD223 Patients with known symptomatic brain metastases. Patients with a "currently active" second malignancy other than non-melanoma skin or superficial urothelial cancers are not eligible. Patients with baseline QT prolongation >470msec or receiving concomitant medications that prolong QTC Patients with bulky visceral disease defined as >4cm For more Information, Traci Southwell, RN Clinical Research Coordinator Traci.Southwell@jefferson.edu Regional Network Office SKCN E-News 2

3 Title: A Phase III Multicenter Trial Evaluating the Efficacy and Safety of MitoGel on Ablation of Upper Urinary Tract Urothelial Carcinoma Sponsor: UroGen Pharma PI: Scott Huboksy MD Primary Objective: A Prospective, single-arm trial designed to assess the efficacy, safety, and tolerability of treatment with MitoGel instilled in the upper urinary system of patients with non-invasive low-grade (LG) UTUC Treatment: approximately per patient: 1-3 week screening period, 6 weeks treatment period, 5 weeks post treatment to PDE, up to 12 months Follow- Up (FU) period from the PDE including a maintenance therapy of a single instillation once monthly up to 11 months FU. Eligibility: Inclusion Criteria Patient must be at least 18 years of age. Naïve or recurrent patients with LG, non-invasive UTUC in the pyelocalyceal system. Patient has at least one (1) measurable and biopsy confirmed papillary LG tumor, evaluated visually, <15 mm. The largest lesion should not exceed 15 mm. Following biopsy, patient should have at least one remaining lesion evaluated visually with a diameter of at least 5 mm ECOG performance status <3 No active urinary tract infection (UTI) as confirmed by urine culture or urinalysis Exclusion Criteria: Patients received BCG treatment for UC during the 6 months prior to Visit 1. Patient has untreated concurrent urothelial cancer in other locations other than the target area (unless treated during screening). Carcinoma in situ (CIS) in the past in the urinary tract. Patient has a history of invasive urothelial carcinoma in the urinary tract during the past five (5) years. Patient has a history of high grade papillary urothelial carcinoma in the urinary tract during the past two (2) years. Any other malignancy diagnosed within 2 years of trial entry with the exception of : Basal or squamous cell skin cancers, or Noninvasive cancer of the cervix, or Any other cancer deemed to be of low risk for progression or patient morbidity during the trial period. Patient with urinary obstruction in a case of retrograde administration or administration not feasible via a nephrostomy tube. Inability to deliver the investigational drug to the pyelocalyceal system. For more Information, Katherine Burns Clinical Research Coordinator Katherine.burns@jefferson.edu NRG BN003: A Phase III Trial of Observation versus Irradiation for a Gross Totally Resected Grade II Meningioma SWOG 1609: DART: Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors NRG GU003: A Randomized Phase III Trial of Hypofractionated Post-Prostatectomy Radiation Therapy (HYPORT) Versus Conventional Post-Prostatectomy Radiation Therapy (COPORT) NRG LU002: Maintenance Systemic Therapy Versus Consolidative Stereotactic Body Radiation Therapy (SBRT) Plus Maintenance Systemic Therapy for Limited Metastatic Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase II/III Trial Regional Network Office SKCN E-News 3

4 Delegation of Task Log (DTL) There are still spaces left for the Delegation of Task Log (DTL) webinar on Tuesday, September 26th from 2 to 4 pm ET. Register on the CTSU website. The webinar and slide set will be posted to the CTSU website following the meeting. The CTSU will be scheduling a webinar in mid-october to discuss the use and benefits of three quality management tools available on the CTSU members website (i.e., the Site Audit Portal, Central Monitoring Portal, and Data Quality Portal). An invitation with registration details will be distributed once a date has been set. Registration information will also be included in the October 8 th CTSU Bi-Monthly Broadcast. EAY131 (MATCH) Subprotocol S1, Phase II Study of Trametinib in Patients with Tumors with NF1 Mutations has been suspended until further notice due to the study-specified limitations placed on the expanded accrual goal for this arm, per Section 8.1 of the MATCH Master Protocol. Patients who have received an assignment to Subprotocol S1 by 9/13/17 will be allowed to register if all eligibility requirements are met. Patients who are currently being treated on Subprotocol S1 will continue on the study with no changes in their participation according to the Master Protocol and Subprotocol. NCI Registration and Credential Repository (RCR) All individuals involved in the conduct of NCI-supported trials as an Investigator (IVR), Non-Physician Investigator (NPIVR), or Associate Plus (AP) will utilize the RCR application to re-register at the time of their next annual registration. SKCN Informed Consent addendum update The PSU is currently revising all network site informed consent addendums. Please be on the look out for any new information from the PSU for site specific information. VTOC Training The VTOC Webinar Training Series schedule and registration is available for NRG Oncology Research Associates working on RTOG 0924, RTOG 0920, NRG-HN001, NRG-HN002, and NRG-CC003. Space is limited so register now and reserve your seat. The next webinar training is scheduled for October 11, NRG Oncology Biospecimen Bank Pittsburgh Please check to be sure that the NRGbiobankPGH@nrgoncology.org address is not blocked at your site. Biobank staff have experienced some issues with sending s to sites. Therefore, to ensure receipt of s from this address at your site, contact your local IT Department and make sure the address is whitelisted. If you have a patient coming in, please contact the RNO at RNORegulatory@jefferson.edu so that we can work with your site to expediate your requests. NRG GY004, Phase III Study Comparing Single-Agent Olaparib or the Combination of Cediranib and Olaparib to Standard Platinum- Based Chemotherapy in Women with Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer, continuing review approved. E1609, A Phase III Randomized Study of Adjuvant Ipilimumab Anti- CTLA4 Therapy Versus High-Dose Interferon a-2b for Resected High-Risk Melanoma, protocol update 2 is CIRB approved. Save the Dates: SOCRA Annual Meeting: October 6-8, Orlando FL ECOG-ACRIN Semiannual Meeting: October 26-28, Orlando, FL Jefferson Oncology Group Annual Meeting: December 6, Philadelphia PA CRA Research Update: December 13, Philadelphia, PA NRG Oncology Semiannual Meeting: January 25-27, Phoenix, AZ ECOG-ACRIN Semiannual Meeting: May 3-5, Chicago IL NRG Oncology Semiannual Meeting: July 12-14, Philadelphia PA The Clinical Research E-News: Archive is now located on the Sidney Kimmel Cancer Center webpage under the SKCN Member Area: Sidney Kimmel Cancer Network Homepage: -This page contains links to the Remote Access Portal. Regional Network Office SKCN E-News 4

5 Contact Information: Cynthia Perez, BS, CCRP NCTN Manager Editor, E-Newsletter Anthony Roberts, BS JOG Coordinator Co-Editor, E-Newsletter Joshua Schoppe, MPH, CCRP Senior Director, RNO Suzanne Jorfi, BS, CCRP Regulatory Manager Office: Office: Office: Office: NRG Oncology, ECOG-ACRIN, CTSU or E-Newsletter inquiries JOG E-Newsletter inquiries RNO and SKCN inquiries Regulatory Update inquiries o CIRB Protocol Support Unit RNORegulatory@jefferson.edu Regulatory Related inquires For URGENT ISSUES, Please call the RNO cellphone at Regional Network Office SKCN E-News 5