CLINCAL RESEARCH

What is Clinical Research?

Cancer Specialists of North Florida has been involved in clinical trials since 1995. We have continued our efforts and actively pursued and expanded our clinical trials to fit the community setting. Our group participated in indication Phase III trials that led to the approval of many key oncology drugs.

Our clinical research team participates in a wide variety of research initiatives on an ongoing basis. Our physicians work in partnership with our panel of research coordinators to study, evaluate, and conduct new drug therapy protocols for participating patients. Together, they bring the most meaningful advances to cancer care in our community.

OPEN CLINICAL TRIALS

Breast Cancer

NCT04873362
Genentech WO42633
A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy
NCT04109066
BMS CA209-7FL
A Randomized, Multicenter, Double-blind, Placebo-controlled Phase 3 Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Patients With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (Her2-) Primary Breast Cancer

Head and Neck

Hematology

N/A
American Regent Injectafer PRO
Patient Reported Outcomes Assessment in Patients Receiving INJECTAFER for the Treatment of Iron Deficiency Anemia
NCT03764618
Rigel C-935788-057
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia

Lung Cancer

NCT04487080
Janssen NSC3003 MARIPOSA
A Phase 3, Randomized Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib Versus Lazertinib as First-Line Treatment in Patients with EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Mariposa)
NCT03800134
Astra Zeneca D9106C00001 AEGEAN
A Phase III, Double-blind, Placebo-controlled, Multi-center International Study of Neoadjuvant / Adjuvant Durvalumab for the Treatment of Patients with Resectable Stages II and III Non-Small Cell Lung Cancer (AEGEAN)
NCT04613596
Mirati Therapeutics MRTX- 849-007
A Phase 2 Trial of MRTX849 in Combination with Pembrolizumab in Patients with Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutation

Lymphoma

NCT03816683
AstraZeneca D8220R00004
Treatment Pattern, Outcomes, and Patient-Reported Health-Related Quality of Life: A Prospective Disease Registry of Patients with Mantle Cell Lymphoma Treated with Novel Agents
NCT04182204
Genentech MO40598
A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Safety and Efficacy of Polatuzumab Vedotin in Combination with Rituximab Plus Gemcitabine Plus Oxaliplatin (R-GEMOX) Versus R-Gemox Alone in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma
NCT04224493
Epizyme EZH-302
A Phase 1B/3 Double-Blind, Randomized, Active-Controlled, 3-Stage, Biomarker Adaptive Study of Tazemetostat or Placebo in Combination with Lenalidomide Plus Rituxumab in Subjects with Relapsed/Refractory Follicular Lymphoma

Melanoma

NCT03815058
Genentech GO40558
A Phase II, Open-Label, Multicenter, Randomized Study of the Efficacy and Safety of RO7198457 in Combination with Pembrolizumab Versus Pembrolizumab in Patients with Previously Untreated Advanced Melanoma

Multiple Myeloma

NCT03901963
Janssen MMY3021
A Randomized Study of Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Patients with Newly Diagnosed Multiple Myeloma Who Are Minimal Residual Disease Positive After Frontline Autologous Stem Cell Transplant
NCT03110822
Oncotherapeutics I-RUX-15-04
A Phase 1 Study of Ruxolitinib, Steroids and Lenalidomide for Relapsed/Refractory Multiple Myeloma (RRMM) Patients

Myelodysplastic Syndromes

NCT01688011
Celgene Connect Myeloid
Connect® Myeloid: The Myelofibrosis (MF), Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) Disease Registry

Pancreatic Cancer

NCT03377491
Novocure Panova-3
PANOVA-3: Pivotal, randomized, open-label study of Tumor Treating Fields (TTFields, 150kHz) concomitant with gemcitabine and nab-paclitaxel for front-line treatment of locally-advanced pancreatic adenocarcinoma

Prostate

NCT03871816
Janssen PCR0002 Prevalence
Biomarker Study to Determine Frequency of DNA-repair Defects in Men with Metastatic Prostate Cancer

Solid Tumor

NCT04083976
Janssen CAN2002
A Phase 2 Study of Erdafitinib in Subjects with Advanced Solid Tumors and FGFR Gene Alterations **High-grade gliomas cohort is closed
NCT02912949
MCLA-128-CL01 Merus
A Phase I/II Study of MCLA-128, a full length IgG1 Bispecific Antibody Targeting HER2 and HER3, in Patients with Solid Tumors

Supportive Care

NCT04299048
Pfizer C3651009
A Phase IB, 12-week, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Repeated Subcutaneous Administrations of PF-06946860 in Patients with Non-Small Cell Lung Cancer and Cachexia

Urothelial Cancer

NCT03036098
BMS CA209-901 CheckMate 901
A Phase 3, Open-label, Randomized Study of Nivolumab Combined with Ipilimumab, or with Standard of Care Chemotherapy, versus Standard of Care Chemotherapy in Participants with Previously Untreated Unresectable or Metastatic Urothelial Cancer **enrolling in Arms C & D (cisplatin-eligible patients)

Blood Draw

NCT03662204
Exact Sciences 2018-01B
Stool Collection Sub-Study of Exact Sciences Protocol 2018-01: "Blood Sample Collection to Evaluate Biomarkers in Subjects with Untreated Solid Tumors"
NCT03662204
Exact Sciences 2018-01
Blood Sample Collection to Evaluate Biomarkers in Subjects with Untreated Solid Tumors
N/A
Seer 020102
A Prospective Blood Sample Collection Study to Evaluate a Panel of Protein-based Biomarkers

Tempus Time Trial Program

CSNF is part of The TIME Trial Program, a just-in-time network of providers that supports rapid patient identification, site activation, and enrollment of select clinical trials. Building off of existing relationships with a large network of community hospitals and practices, TIME activates clinical trials at pre-qualified sites in its network in an average of 10 days, bringing the very best clinical trials to community centric parts of this country and giving access to thousands of patients that have historically been denied novel therapeutics. As part of The TIME Trial Network, CSNF has access to the biggest marketplace of trials that can be quickly initiated when there is a patient on-site that is ready to enroll. The program's just-in-time model allows for both sites and sponsors to locate extremely rare patients and then open a trial specifically on that patient’s behalf in a fraction of the time it typically takes.

RELEVANT STUDIES

Journal

Study

CSNF Principal Investigators

Leukemia &
Efficacy and Safety of Ofatumumab and Bendamustine Followed by Ofatumumab Maintenance in Patients with Relapsed Indolent Non-Hodgkin Lymphoma After Prior Rituximab
Mehdi Moezi, MD
The New England Journal of Medicine
Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer
Bijoy Telivala, MD; Daniel Kobrinski, DO

RESEARCH COMMITTEE

Mehdi M. Moezi, MD, FACP

Medical Director of Clinical Research

Safeer Ashraf, MD

Hematology/Oncology

Ayed Ayed, MD

Hematology/Oncology

Richard Cassidy, MD, DABR

Radiation Oncology

Daniel Kobrinski, DO

Hematology/Oncology

Laura Lourdes, MD

Hematology/Oncology

Satish Shanbhag, MD, MPH

Hematology/Oncology

Ilicia Shugarman, MD

Hematology/Oncology

Gaurav Trikha, MD

Hematology/Oncology

Hema Vankayala, MD

Hematology/Oncology

MaryAlice Anderson, PharmD

Research Manager

RESEARCH TEAM

Bhaloo, Coordinator

Baptist South/Southpoint

Suzanne, Coordinator

Beaches

Amanda, Coordinator

Clay/Fleming Island

Amy, Coordinator

Riverside/Northside

Jacob, Coordinator

Southside

Tamara, Coordinator

Floater

Kimberly, Coordinator

Floater

Frequently Asked Questions

Clinical Trial Phases

Contact Us

Want more information? Contact our Research Manager!

MaryAlice Anderson, PharmD
MaryAlice.Anderson@CSNF.us
Phone: (904) 363.7462
Fax: (904) 538.3468