b'Redefining Research & CareClinical Trials Biomarkers/Imaging Safety Lead-in Phase II Trial of Neo- Immunotherapy with Nivolumab andA Phase Ib Adaptive Dose-Finding Adjuvant SABR for IVC Tumor ThrombiIpilimumab Followed by NivolumabStudy of ARO-HIF2 in Patients with Prognostic Significance of Circulatingin Newly Diagnosed RCC or Nivolumab with CabozantinibAdvanced ccRCCTumor Cells in Patients with RCC ID: NCT02473536 for Patients with Advanced KidneyID: NCT04169711Principal Investigator: Principal Investigator: Cancer, The PDIGREE Study Principal Investigator:Vitaly Margulis, M.D. Raquibul Hannan, M.D., Ph.D. ID: NCT03793166 James Brugarolas, M.D., Ph.D.Contact: Allison Beaver, RN Contact: Samantha Mannala Principal Investigator: Contact: Tomi FatundePhone: 214-645-8787 Phone: 214-648-1873 Suzanne Cole, M.D. Phone: 214-648-4972Efficacy & Tolerability Email: Allison.Beaver@utsw.edu Email: Samantha.Mannala@utsw.edu Contact: Ashley Turk Email: Oluwatomilade.Fatunde@utsw.eduPhone: 972-669-704489Zr-DFO-Atezolizumab ImmunoPET/ Email: Ashley.Turk@utsw.eduSafety & Dose 2 Comparative CT in Patients with Locally AdvancedNeoadjuvant Phase II Trial of SABR for PatientsAdvanced RCC Finding 1 3 Effectiveness or Metastatic RCC A Phase III Randomized Studywith Oligometastatic RCC Prior PD1/PDL1ID: NCT04006522Principal Investigator: Comparing Perioperative NivolumabID: NCT02956798 A Phase I and II, Open-label, James Brugarolas, M.D., Ph.D. vs. Observation in Patients withPrincipal Investigator: Multicenter, Dose Escalation and Contact: Kelli Key Localized RCC UndergoingRaquibul Hannan, M.D., Ph.D. Dose Expansion Study of NKTR-262 With numerous clinical trials, the Kidney Cancer ProgramPhone: 214-648-8152 Nephrectomy (PROSPER) Contact: Samantha Mannala in Combination with NKTR-214 and Email: Kelli.Key@utsw.edu ID: NCT03055013 Phone: 214-648-1873 in Combination with NKTR-214 Plus offers patients the latest treatments currently under devel- Principal Investigator: Email: Samantha.Mannala@utsw.edu Nivolumab in Patients with Locally opment. The Kidney Cancer Program is a standard-bearerAdvanced MR Imaging in theVitaly Margulis, M.D. Advanced or Metastatic Solid Tumor in testing new approaches, including cutting-edgeCharacterization of RCC: CorrelationContact: Allison Beaver, RN Malignancieswith Pathology and Gene ExpressionPhone: 214-645-8787 Advanced RCCID: NCT03435640radiotherapy and immunotherapy, making new progressProfiles Email: Allison.Beaver@utsw.edu Prior Treatment Principal Investigator:against the disease. For example, the phase 3 clinicalPrincipal Investigator:James Brugarolas, M.D., Ph.D.trials leading to the FDA approval of both nivolumabIvan Pedrosa, M.D., Ph.D. Phase II Trial of Stereotactic AblativeContact: Tomi FatundeContact: Michael Fulkerson Adjuvant Radiation Therapy (SAbR) forPhone: 214-648-4972and the combination of nivolumab and ipilimumabPhone: 214-648-5984 Oligoprogressive ccRCC Email: Oluwatomilade.Fatunde@utsw.eduwere opened at the Kidney Cancer Program. This gaveEmail: Michael.Fulkerson@utsw.edu A Phase III Multicenter, Randomized,ID: NCT03696277 UT Southwestern patients access to these medicationsPlacebo-Controlled, Double-BlindPrincipal Investigator: Phase II BMS FRACTION Study to Test Multiparametric MRI in T1b-T4 Study of Atezolizumab (anti-PD-L1Raquibul Hannan, M.D., Ph.D. Combination Treatmentsbefore they were commercialized for kidney cancer.Renal Masses antibody) as Adjuvant Therapy inContact: Samantha Mannala Principal Investigator:Clinical trials are vetted by an expert panel thatPrincipal Investigator: Patients with RCC at High Risk ofPhone: 214-648-1873 Hans Hammers, M.D., Ph.D.includes Dr. Courtney, Disease-Oriented Team oncologyIvan Pedrosa, M.D., Ph.D. Developing Metastasis FollowingEmail: Samantha.Mannala@utsw.edu Contact: Allison Beaver, RNContact: Michael Fulkerson Nephrectomy Phone: 214-645-8787leader, Dr. Hammers, Co-Leader for Clinical Research ofPhone: 214-648-5984 ID: NCT03024996 A Phase I/II Study Exploring theEmail: Allison.Beaver@utsw.eduthe Kidney Cancer Program, and Dr. Brugarolas. Together,Email: Michael.Fulkerson@utsw.edu Principal Investigator: Safety, Tolerability, and Efficacy they ensure that only trials perceived to have a highJames Brugarolas, M.D., Ph.D. of Pembrolizumab (MK-3475) inPhase I/Ib Study to Evaluate the A Prospective Comparison of Whole- Contact: Dendra Von Merveldt, RN Combination with EpacadostatSafety and Tolerability of CPI-444 likelihood of helping patients open at UT Southwestern.body Magnetic Resonance Imaging,Phone: 214-648-8787 (INCB024360) in Subjects withAlone and in Combination With In addition, the most challenging kidney cancer cases areSodium Fluoride Positron EmissionEmail: Dendra.Vonmerveldt@utsw.edu Selected Cancers Atezolizumab in Advanced Cancersreviewed by a group of experts (see page 33) to deter- Tomography, and Whole-body BoneID: NCT02178722ID: NCT02655822 Scintigraphy for Diagnosis of RCCA Phase III Randomized, Double- Principal Investigator: Principal Investigator:mine which treatments are most likely to benefit a specificOsseous Metastases Blind, Placebo-Controlled Trial ofAravind Sanjeevaiah, M.D. Kevin Courtney, M.D., Ph.D.patient. Access to new therapies, along with expertPrincipal Investigator: Pembrolizumab in Adjuvant RCC Contact: Pamela Kurian, M.S. Contact: Nour Sukarmultidisciplinary care, contribute to survival rates forIvan Pedrosa, M.D., Ph.D. ID: NCT03142334 Phone: 214-648-5874 Phone: 214-648-5107Contact: Sydney Haldeman Principal Investigator: Email: Pamela.Kurian@utsw.edu Email: Nour.Sukar@utsw.eduUT Southwestern patients that exceed national averagesPhone: 214-648-5478Hans Hammers, M.D., Ph.D.(see page 10). Email: Sydney.Haldeman@utsw.edu Contact: Allison Beaver, RN A Phase II Study to Evaluate theSafety and Efficacy Study of IMSA101 UT Southwestern is just one of 30 sites nationwidePhone: 214-645-8787 Safety, Pharmacodynamics, andin Refractory MalignanciesEmail: Allison.Beaver@utsw.edu Efficacy of Entinostat in CombinationID: NCT04020185receiving federal funding as a National Clinical TrialsLocalized RCC with Nivolumab/Ipilimumab in PatientsPrincipal Investigator:Network Lead Academic Participating Sitea hub for clin- with RCC Previously Treated withShaalan Beg, M.D.ical cancer research, especially for large, multi-institutionSuccess of Active Surveillance inAdvanced RCCNivolumab/Ipilimumab Contact: Melissa RodriguezPatients with Untreated Small RenalNo Prior Treatment ID: NCT03552380 Phone: 214-648-6593trials sponsored by national cooperative groups. Masses with the Option of DelayedPrincipal Investigator: Email: Melissa.Rodriguez@utsw.edu In addition, UT Southwestern, in partnership with MDTreatment A Phase II Trial of Stereotactic BodyHans Hammers, M.D., Ph.D.Anderson Cancer Center (lead), Cleveland Clinic, and BethPrincipal Investigator: Radiation Therapy in CombinationContact: Mackenzie Tsang-Lee Vitaly Margulis, M.D. with Nivolumab plus Ipilimumab inPhone: 214-648-7001Israel Deaconess/Harvard Cancer Center, received a Contact: Allison Beaver, RN Patients with Metastatic RCCEmail: Mackenzie.Tsang-Lee@utsw.edu$1 million award from the Congressionally directed KidneyPhone: 214-645-8787 ID: NCT03065179Cancer Research Program to establish a National ClinicalEmail: Allison.Beaver@utsw.edu Principal Investigator: A Phase II Randomized Trial of Hans Hammers, M.D., Ph.D. Radium-223 and Cabozantinib in Trials Consortium. A Phase II Trial of StereotacticContact: Allison Beaver, RN Patients with Advanced RCC with Ablative Body Radiation TherapyPhone: 214-645-8787 Bone Metastasis (SABR) for Patients with Primary RCCEmail: Allison.Beaver@utsw.edu ID: NCT04071223ID: NCT02141919 Principal Investigator:Learn More About Our Clinical TrialsPrincipal Investigator: A Phase II Study of Front-LineSuzanne Cole, M.D.Raquibul Hannan, M.D., Ph.D. Therapy with Nivolumab and SalvageContact: Ashley TurkContact: Samantha Mannala Nivolumab plus Ipilimumab in PatientsPhone: 972-669-7044For an updated list of our clinical trials, please visit www.utsouthwestern.edu/ Phone: 214-648-1873 with Advanced RCCEmail: Ashley.Turk@utsw.edu departments/kidney-cancer/clinical-trials Email: Samantha.Mannala@utsw.edu ID: NCT03117309Principal Investigator:Hans Hammers, M.D., Ph.D.Contact: Allison Beaver, RNPhone: 214-645-8787Email: Allison.Beaver@utsw.edu62 63'