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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.

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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


A Randomized, Controlled, Open-label Study of the Efficacy, Durability, and Safety of UGN-102 With or Without TURBT in Patients with Low Grade Intermediate Risk Non-Muscle Invasive Bladder Cancer (LG IR NMIBC) (ATLAS)
Principal Investigator: Matthew Nielsen, MD, MS, FACS
Sponsor: UroGen
Contact: Chris Paterno (ph: 919-537-3505)

A Phase 3 Study of UGN-102 for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (ATLAS)

https://clinicaltrials.gov


(Quilt 2.005) A study of intravesical Bacillus Calmette-Guerin (BCG) in Combination with ALT-803 in Patients with Non-Muscle Invasive Bladder Cancer
Principal Investigator: Marc Bjurlin, DO, MSc, FACOS
Sponsor: Immunity Bio
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 never had BCG treatments before.

https://clinicaltrials.gov


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/


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: Marc Bjurlin, DO, MSc, FACOS
Sponsor: Immunity Bio
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/


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


Comparing Intravesical Therapy & Surgery as Treatment Options (CISTO)
Principal Investigator: Angela Smith, MD, MS, FACS
Sponsor: PCORI
Contact: Dana Mueller (ph: 919-962-4671)

CISTO is a pragmatic observational study to compare patient-reported and patient-centered clinical outcomes between patients undergoing radical cystectomy and those receiving bladder-sparing intravesical therapies for NMIBC that have failed first-line BCG.

cistostudy.org