Selected Clinical Trials
Clinical Trials
The mission of the UF Health Cancer Center Clinical Trials Office (CTO) is to help deliver new and promising cancer treatments that improve the lives of our patients at the UF Health Cancer Center. The CTO provides support to our clinical investigators for the development and implementation of cancer clinical trials — facilitating the conduct of high-quality clinical research while adhering to the highest ethical standards and maintaining compliance with all governing bodies. This program will continue to undergo significant expansion over the next few years, as part of the initiative to become a National Cancer Institute-designated cancer center.
Currently, our clinical research program consists of the CTO and 11 disease-specific working groups (e.g., thoracic, GI, GU, neuro-oncology, hematologic malignancies). It also supports an Experimental Therapeutics Incubator for early-phase clinical trials that may have patient eligibility across several cancer types. Additionally, the Clinical Trials Office provides clinical trial support for outside institutions with affiliations through UF Health, the university’s academic health center.
Affiliate Clinical Research sites include:
- North Florida/South Georgia Veterans Health System (Gainesville, FL)
- Tallahassee Memorial Cancer Center (Tallahassee, FL)
- UF Health Proton Therapy Institute (Jacksonville, FL)
- Broward Health Medical System (Fort Lauderdale, FL)
- Orlando Health UF Health Cancer Center (Orlando, FL)
Affiliation with National Cancer Institute mades novel cancer treatments available to patients

The UF Health Cancer Center joined the National Cancer Institute’s Experimental Therapeutics Clinical Trial Network, or ETCTN, in December 2017 under the leadership of the University of Pittsburgh Cancer Institute.
As a member of the network, the UF Health Cancer Center can give patients access to early phase experimental therapeutic clinical trials — research studies that assess new treatments for efficacy and safety. Such novel treatments are developed by scientists across the NCI’s network of centers and conducted at ETCTN locations.
Membership in the ETCTN provides UF Health Cancer Center researchers and clinicians funding to conduct these investigations and a platform to present their ideas for the development of new treatments as clinical trials — while allowing collaboration with other leading cancer centers.
“We anticipate having the first set of these trials to offer to patients in early spring 2018,” said Thomas George, M.D., the associate director for clinical investigations at the Cancer Center.
Clinical Trial NaviGATOR
The UF Health Cancer Center’s new Clinical Trial NaviGATOR mobile app gives patients and clinicians the ability to browse cancer clinical trials at the center by disease site and criteria, and to contact the center to make referrals or get additional information. The NaviGATOR is available on the web and is also available as an app for mobile devices.
Selected Clinical Trials
Breast
Phase: Pilot
NCT02199366
Investigator: Julie Bradley, M.D
Study Title: Prospective Pilot Study of Early Markers of Radiation-Induced Cardiac Injury in Patients with Left-Sided Breast Cancer Receiving Photon or Proton Therapy
Phase: II
NCT02101385
Investigator: Karen C. Daily Weinstein, D.O.
Study Title: A Phase II Randomized Controlled Trial of Genomically Directed Therapy After Preoperative Chemotherapy in Patients with Triple-Negative Breast Cancer
Phase: II
NCT02750826
Investigator: Karen C. Daily Weinstein, D.O.
Study Title: Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer
Experimental Therapeutics Group
Phase: N/A
NCT02664350
Investigator: Larisa Humma Cavallari, PharmD
Study Title: Precision Medicine Guided Treatment for Cancer Pain
Phase: I/II
NCT02709889
Investigator: Frederic J. Kaye, M.D.
Study Title: An Open-Label Study of Rovalpituzumab Tesirine in Subjects with Delta-Like Protein 3-Expressing Advanced Solid Tumors
Phase: I/II
NCT03126110
Investigator: Thomas J. George, M.D., FACP
Study Title: A Phase I/II study exploring the safety, tolerability, and efficacy of INCAGN01876 in combination with immune therapies in subjects with advanced or metastatic malignancies
Phase: I
NCT02134197
Investigator: Frederic J. Kaye, M.D.
Study Title: An open-label Phase I dose-escalation study to evaluate the safety, tolerability, maximum tolerated dose, pharmacokinetics, and pharmacodynamics of the anti-C4.4a antibody drug conjugate BAY 1129980 in subjects with advanced solid tumors known to express C4.4a
Phase: II
NCT02834013
Investigator: Thomas J. George, M.D., FACP
Study Title: DART: Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors
Gastrointestinal
Phase: II
NCT02935634
Investigator: Thomas George, M.D., FACP
Study Title: A Phase 2, Fast Real-time Assessment of Combination Therapies in Immuno-ONcology Study in Participants with Advanced Gastric Cancer (FRACTION-Gastric Cancer)
Phase: II
NCT02921737
Investigator: Jennifer M. Duff, M.D.
Study Title: A Phase II Trial of TAS-102 (Lonsurf) in Patients with Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma After Progression Through First Line Chemotherapy
Phase: III
NCT02562755
Investigator: Roniel Cabrera, M.D., M.S.
Study Title: A Phase III Randomized, Open-Label Study Comparing Pexa-Vec (Vaccinia GM-CSF/Thymidine Kinase-Deactivated Virus) Followed by Sorafenib Versus Sorafenib in Patients with Advanced Hepatocellular Carcinoma (HCC) Without Prior Systemic Therapy
Genitourinary
Phase: III
NCT02773849
Investigator: Paul Luther Crispen, M.D.
Study Title: A Phase III, Open Label Study to Evaluate the Safety and Efficacy of INSTILADRIN® (rAd-Interferon (IFN)/Syn3) Administered Intravesically to Patients With High Grade, BCG Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)
Phase: III
NCT03091660
Investigator: Paul Luther Crispen, M.D.
Study Title: A Phase III Randomized Trial to Evaluate the Influence of BCG Strain Differences and T Cell Priming With Intradermal BCG Before Intravesical Therapy for BCG-Naive High-Grade Non-muscle Invasive Bladder Cancer
Head and Neck
Phase: I
NCT02775812
Investigator: Natalie Lee Silver, M.D., M.S.
Study Title: A Phase I and Expansion Cohort Study of Adjuvant Cisplatin, Intensity-Modulated Radiotherapy, and MK-3475 (Pembrolizumab) in High-risk Head and Neck Squamous Cell Carcinoma (HNSCC)
Phase: II
NCT03077243
Investigator: Robert Amdur, M.D.
Study Title: LCCC 1612: P53 mutational status and circulating free HPV DNA for the management of HPV-associated Oropharyngeal Squamous Cell Cancers
Lymphoma
Phase: I/II
NCT01994382
Investigator: Nam H. Dang, M.D., Ph.D.
Study Title: A Phase I/II Open-Label, Multi-Dose, Multi-Center Escalation and Exploratory Study of Cerdulatinib (PRT062070) in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) or B Cell or T Cell Non-Hodgkin Lymphoma (NHL)
Malignant Hematology
Phase: N/A
NCT02435550
Investigator: Christopher R. Cogle, M.D.
Study Title: iCare for Cancer Patients
Phase: I/II
NCT02773732
Investigator: Randall A. Brown, M.D.
Study Title: A Phase Ib/II Clinical Trial of Oral Ciprofloxacin and Etoposide in Subjects with Resistant Acute Myeloid Leukemia (AML)
Phase: I
NCT02370888
Investigator: Maxim N. Norkin, M.D., Ph.D.
Study Title: A phase I clinical trial to evaluate the maximally tolerated dose (MTD), dose limiting toxicities (DLTs) and safety profiles of increasing doses of lenalidomide after allo-HCT in AML and MDS subjects with minimal residual disease (MRD) detected by the CD34+ mixed chimerism analysis
Phase: II
NCT02963493
Investigator: Jan S. Moreb, M.D.
Study Title: A Single Arm, Open-Label, Phase II Study of Mel ufen in Combination with Dexamethasone in Patients with Relapsed Refractory Multiple Myeloma who are Refractory to Pomalidomide and/or Daratumumab
Phase: II
NCT02654990
Investigator: Jan S. Moreb
Study Title: A Multicenter, Randomized, Open-Label Phase II Study Evaluating the Safety and Efficacy of Three Different Regimens of Oral Panobinostat in Combination with Subcutaneous Bortezomib and Oral Dexamethasone in Patients with Relapsed or Relapsed/ Refractory Multiple Myeloma Who Have Been Previously Exposed to Immunomodulatory Agents
Phase: III
NCT03016130
Investigator: Hemant Sreenivasa Murthy, M.D.
Study Title: A Phase III, Randomized, Clinical Trial Comparing Two Diets in Patients undergoing Hematopoietic Stem Cell Transplant (HSCT) or Remission Induction Chemotherapy for Acute Leukemia and Myelodysplastic Syndrome
Phase: III
NCT03139604
Investigator: Nosha Farhadfar, M.D.
Study Title: A Randomized, Double-Blind, Placebo-Controlled Phase III Study of Itacitinib or Placebo in Combination with Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease
Neurologic
Phase: I/II
NCT03139604
Investigator: David Dinh Tran, M.D., Ph.D.
Study Title: A Phase I and Open Label, Randomized, Controlled Phase II Study Testing the Safety, Toxicities, and Efficacy of MK-3475 in Combination with MRI-guided Laser Ablation in Recurrent Malignant Glioma
Phase: II
NCT02465268
Investigator: Maryam Rahman, M.D.
Study Title: A Phase II Randomized, Blinded, and Placebo-controlled Trial of CMV RNA-Pulsed Dendritic Cells with Tetanus-Diphtheria Toxoid Vaccine in Patients with Newly-Diagnosed Glioblastoma
Phase: II
NCT02663271
Investigator: David Dinh Tran, M.D., Ph.D.
Study Title: A Phase II, Multi-center, Single arm, Histologically Controlled Study Testing the Combination of TTFields and Pulsed Bevacizumab Treatment in Patients with Bevacizumab-refractory Recurrent Glioblastoma
Pediatrics
Phase: I/II
NCT02642965
Investigator: William B. Slayton, M.D.
Study Title: A Phase I/II Study of CPX-351 (NSC# 775341) Alone Followed by Fludarabine, Cytarabine, and G-CSF (FLAG) for Children With Relapsed Acute Myeloid Leukemia (AML) (IND: 129443)
Phase: II
NCT01326104
Investigator: Duane Alan Mitchell, M.D., Ph.D.
Study Title: Recurrent Medulloblastoma and Primitive Neuroectodermal Tumor Adoptive T Cell Therapy During Recovery from Myeloablative Chemotherapy and Hematopoietic Stem Cell Transplantation
Phase: II
NCT02306161
Investigator: William B. Slayton, M.D.
Study Title: Randomized Phase II Trial Evaluating the Addition of the IGF-1R Monoclonal Antibody Ganitumab (AMG 479, NSC# 750008, IND# 120449) to Multiagent Chemotherapy for Patients with Newly Diagnosed Metastatic Ewing Sarcoma
Phase: II
NCT02723994
Investigator: William B. Slayton, M.D.
Study Title: A Phase II Study of the JAK1/JAK2 Inhibitor Ruxolitinib With Chemotherapy in Children With De Novo High-Risk CRLF2-Rearranged and/or JAK Pathway-Mutant Acute Lymphoblastic Leukemia
Phase: II
NCT02900976
Investigator: William B. Slayton, M.D.
Study Title: A Pilot Study of Rituximab (RTX) and Third Party Latent Membrane Protein (LMP)-Specific Cytotoxic T-Lymphocytes in Pediatric Solid Organ Recipients (SOT) With EBV-Positive CD20-Positive Post-Transplant Lymphoproliferative Disease (PTLD)
Phase: II
NCT02900976
Investigator: Joanne P. Lagmay, M.D.
Study Title: Phase II Study of Nab-Paclitaxel in Combination with Gemcitabine for Treatment of Recurrent/Refractory Sarcoma in Teenagers and Young Adults
Thoracic
Phase: I/II
NCT01770418
Investigator: Bradford S. Hoppe, M.D., MPH
Study Title: A Phase I/II Study of Hypofractionated Proton Therapy for Stage II-III Non-Small Cell Lung Cancer
Phase: I/II
NCT02920450
Investigator: Dennie Vance Jones, M.D.
Study Title: A Non-Randomized Phase Ib-II Protocol of Paclitaxel, Carboplatin and the Dual PI3K/mTOR Kinase Inhibitor, PF- 05212384, for Patients with Advanced, or Metastatic Non-Small Cell Carcinoma of the Lung
Phase: II
NCT02920476
Investigator: Dennie Vance Jones, M.D.
Study Title: A Phase II Trial of TAS-102 (Lonsurf) in Previously Treated Unresectable or Metastatic Squamous Cell Carcinoma of the Lung
Phase: II/III
NCT03137771
Investigator: Anamaria R. Yeung, M.D.
Study Title: 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
Phase: III
NCT03033511
Investigator: Priya K. Gopalan, M.D., Ph.D.
Study Title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects with Extensive Stage Small Cell Lung Cancer (MERU)
Phase: III
NCT02831959
Investigator: David Dinh Tran, M.D., Ph.D.
Study Title: Pivotal, open-label, randomized study of radiosurgery with or without Tumor Treating Fields (TTFields) for 1-10 brain metastases from non-small cell lung cancer (NSCLC)