Innovations in healthcare are made possible through clinical trials. Clinical trials are research studies involving human participants that evaluate the effects of new tests, drugs, interventions, or procedures on health outcomes. Participation in clinical trials may enable you to take a more active role in your own health care, gain access to new tests and treatments before they are widely available, and help others by contributing to medical research.

Read More
Human studies, or clinical trials, are sponsored or funded by a variety of sources such as physicians, hospitals, foundations, pharmaceutical companies, voluntary or advocacy groups, universities and government agencies. Ideas for clinical trials usually come from researchers. These researchers will test new therapies or procedures in the laboratory and in animal studies, and the most promising results move on to clinical trials.

Choosing to participate in a clinical trial is an important personal decision. Carefully conducted clinical trials are the fastest and safest way to find whether new drugs or treatments are both safe and effective. Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research. All clinical trials have guidelines about who can participate. Researchers have protocols with defined criteria to identify appropriate participants and maintain safety standards.

In addition to the trials developed at UNC, there are national trials that you can learn about by visiting the National Institutes of Health website at clinicaltrials.gov.

Currently Available Clinical Trials


Establishing the Safety and Efficacy of Reloxaliase in Patients With Enteric Hyperoxaluria (URIROX-2)
Principal Investigator: Davis Viprakasit, MD
Sponsor: Allena Pharmaceuticals
Contact: Emily Mercer (ph: 919-843-1130) or Chris Paterno (ph: 919-537-3505)

This study is designed to determine the short- and long-term efficacy of reloxaliase in terms of reducing urinary oxalate excretion and clinical benefits compared to placebo.

https://clinicaltrials.gov/


Prospective Validation of Prostate Biomarkers for Repeat Biopsy: The PRIORITY Study
Principal Investigator: Marc Bjurlin, DO, MSc, FACOS
Sponsor: MDxHealth
Contact: Emily Mercer (ph: 919-843-1130)

This study tests the validity of two prostate cancer screening tests to help guide physicians’ decisions about patient care and reduce the need for multiple prostate biopsies.

Eligible patients will have previously had a negative prostate biopsy and are planning a repeat biopsy.

https://clinicaltrials.gov/


Using Virtual Reality (VR) Models for Preoperative Planning
Principal Investigator: Eric Wallen, MD
Sponsor: Ceevra, Inc.
Contact: Emily Mercer (ph: 919-843-1130) or Chris Paterno (ph: 919-537-3505)

This study evaluates whether assess virtual reality (VR) models improve surgery efficiency and outcomes for patients undergoing surgery for kidney and prostate cancer. VR models will be created from CT/MRI imaging of patients planning to undergo a robotic prostatectomy.

https://clinicaltrials.gov/


A Phase 2b, Single-Arm, Multicenter Trial to Evaluate the Efficacy and Safety of UGN-102 as Primary Chemoablative Therapy in Patients with Low Grade (LG) Non-Muscle-Invasive Bladder Cancer (NMIBC) at Intermediate Risk of Recurrence
Principal Investigator: Angela Smith, MD, MS
Sponsor: UroGen
Contact: Chris Paterno (ph: 919-537-3505)

This study tests the safety and efficacy of a novel agent, Mitogel, to treat patients with low grade non-muscle invasive bladder cancer.

https://clinicaltrials.gov/


QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination with ALT-803 in Patients with BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer
Principal Investigator: Hung-Jui Tan, MD, MSHPM
Sponsor: Altor BioScience
Contact: Chris Paterno (ph: 919-537-3505)

This study tests the safety and efficacy of intravesical BCG plus ALT-803 in patients with high grade non-muscle invasive bladder cancer that have previously failed BCG.

More information: https://clinicaltrials.gov/


A 24-week Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Fesoterodine in Subjects Aged 6 to 17 Years with Symptoms of Detrusor Overactivity Associated with a Neurological Condition (Neurogenic Detrusor Overactivity)
Principal Investigator: Richard Sutherland, MD
Sponsor: Pfizer
Contact: Chris Paterno (ph: 919-537-3505)

This trial evaluates the safety and efficacy of the drug, Fesoterdine, in pediatric patients with urinary incontinence due to neurogenic detrusor overactivity. Fesoterdine is an FDA approved drug in adults, we are testing the safety and use in reducing neurogenic incontinence in pediatric population.

https://clinicaltrials.gov/


S1602, 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
Principal Investigator: Matthew Nielsen, MD, MS
Sponsor: Southwest Oncology Group (SWOG)
Contact: Chris Paterno (ph: 919-537-3505)

This study compares different forms of BCG (Tice BCG {FDA approved} vs. Tokyo 172 BCG vs. Tokyo172 BCG with Vaccine) for patients with high-grade non-muscle invasive bladder cancer (NMIBC).
BCG is the most common immunotherapy for treating early high-grade NMIBC bladder cancer. This study compares two forms of BCG to check safety and outcomes. The hope is to gain FDA approval of Tokyo 172 BCG and provide a second BCG for use in bladder cancer treatments.

https://clinicaltrials.gov


GRADE-SRM: Genomic Risk Assessment and Decisional Evaluation for Small Renal Masses
Principal Investigator: Hung-Jui Tan, MD, MSHPM
Sponsor: Lineberger Comprehensive Cancer Center UCRF
Contact: Shannon Myers (ph: 919-962-8838)

This is a non-randomized, comparative study to evaluate the role of renal mass biopsy on decision-making for patients presenting with clinical T1 kidney tumors. This trial will also determine if genomic information can be accurately obtained from renal mass biopsy samples to help guide management decisions.

https://clinicaltrials.gov


A Study of Apalutamide in Participants With High‑Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy (PROTEUS)
Principal Investigator: Marc Bjurlin, DO, MSc, FACOS
Sponsor: Janssen Research & Development, LLC
Contact: Emily Mercer (ph: 919-843-1130) or Chris Paterno (ph: 919-537-3505)

This is a randomized trial comparing androgen deprivation therapy (ADT) plus apalutamide vs ADT and placebo. Treatment is given before and after radical prostatectomy in participants with high-risk localized or locally advanced prostate cancer.

https://clinicaltrials.gov


A Phase 2 Study of BC-819 in Patients With Non-Muscle Invasive Bladder Cancer (NMIBC) Whose Disease is Unresponsive to Bacillus Calmette-Guerin (BCG)
Principal Investigator: Marc Bjurlin, DO, MSc, FACOS
Sponsor: Anchiano Therapeutics Israel Ltd
Contact: Emily Mercer (ph: 919-843-1130) or Chris Paterno (ph: 919-537-3505)

This study is testing BC-819 in patients with high grade NMIBC previously treated with BCG who have had a recurrence after adequate treatment. BC-819 (inodiftagene vixteplasmid) directs the expression of a potent toxin in cancer cells but not normal tissue which causes the cancer cells to die off.

https://clinicaltrials.gov