Clinical Trials

Biomarkers/Imaging      

Prognostic Significance of Circulating Tumor Cells in Patients with Renal Cell Carcinoma
Principal Investigator: Vitaly Margulis, M.D.
Status: Recruiting
Contact: Allison Beaver, R.N.
Phone: 214-645-8789
allison.beaver@utsouthwestern.edu

Advanced MR Imaging in the Characterization of Renal Cell Carcinoma: Correlation with Pathology and Gene Expression Profiles
Principal Investigator: Ivan Pedrosa, M.D.
Status: Recruiting
Contact: Christina Carrigan, R.N.
Phone: 214-645-2704
christina.carrigan@utsouthwestern.edu

Neoadjuvant/Localized RCC

Success of Active Surveillance in Patients with Untreated Small Renal Masses with the Option of Delayed Treatment
Principal Investigator: Vitaly Margulis, M.D.
Status: Recruiting
Contact: Allison Beaver, R.N.
Phone: 214-645-8789
allison.beaver@utsouthwestern.edu

A Phase II Trial of Stereotactic Ablative Body Radiation Therapy (SABR) for Patients with Primary Renal Cell Carcinoma (RCC) 
Clinical Trials.gov ID: NCT02141919
Principal Investigator: Raquibul Hannan, M.D., Ph.D.
Status: Recruiting
Contact: Susan Cooley, R.N.
Phone: 214-648-1895
Susan.Cooley@UTSouthwestern.edu 

Safety Lead-in Phase II Trial of Neo-adjuvant SABR for IVC Tumor Thrombi in Newly Diagnosed RCC
Clinical Trials.gov ID: NCT02473536
Principal Investigator: Raquibul Hannan, M.D., Ph.D.
Status: Recruiting
Contact: Susan Cooley, R.N.
Phone: 214-648-1895
Susan.Cooley@UTSouthwestern.edu 

A Phase III Randomized Study Comparing Perioperative Nivolumab vs. Observation in Patients with Localized Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER)
Principal Investigator: Vitaly Margulis, M.D.
Status: Pending Review
Contact: Allison Beaver, R.N.
Phone: 214-645-8789
allison.beaver@utsouthwestern.edu

Phase III Randomized Double-Blind, Placebo-Controlled Trial of Pembrolizumab in Adjuvant RCC (KEYNOTE-564)
Principal Investigator: Hans Hammers, M.D.
Status: Pending Review
Contact: Allison Beaver
Phone: 214-648-8789
Allison.Beaver@UTSouthwestern.edu

Advanced RCC - Treatment Naive

Phase III Randomized, Open-label Trial Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination with Axitinib versus Sunitinib Monotherapy as a First-line treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-426)
Principal Investigator: Hans Hammers, M.D.
Status: Approved
Contact: Allison Beaver
Phone: 214-648-8789
Allison.Beaver@UTSouthwestern.edu

A Phase II Trial of High Dose IL-2 and Stereotactic Ablative Body Radiation Therapy (SABR) for Patients with Metastatic Clear Cell Renal Cell Cancer (mRCC)
Clinical Trials.gov ID: NCT01896271
Principal Investigator: Raquibul Hannan, M.D., Ph.D.
Status: Recruiting
Contact: Susan Cooley, R.N.
Phone: 214-648-1895
Susan.Cooley@UTSouthwestern.edu

A Phase III, Randomized, Open-Label Study of Nivolumab Combined with Ipilimumab versus Sunitinib Monotherapy in Subjects with Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma
Clinical Trials.gov ID: NCT02231749
Principal Investigator: James Brugarolas, M.D., Ph.D.
Status: Ongoing, but completed recruitment
Contact: Dendra Von Merveldt, R.N.
Phone: 214-645-8789
dendra.vonmerveldt@utsouthwestern.edu 

A Phase II Study of Front-line Therapy with Nivolumab and Salvage Nivolumab plus Ipilimumab in Patients with Advanced Renal Cell Carcinoma 
Principal Investigator: Hans Hammers, M.D., Ph.D.
Status: Pending Review
Contact: Allison Beaver, R.N.
Phone: 214-645-8789
allison.beaver@utsouthwestern.edu

A Phase II Trial of Stereotactic Body Radiation Therapy in Combination with Nivolumab plus Ipilumimab in Patients with Metastatic Renal Cell Cancer
Clinical Trials.gov ID: NCT03065179
Principal Investigator: Hans Hammers, M.D., Ph.D.

Status: Recruiting
Contact: Allison Beaver, R.N.
Phone: 214-645-8789
allison.beaver@utsouthwestern.edu

A Phase II Randomized Trial of Pazopanib vs. Local Therapy for Renal Cell Carcinoma Patients with Limited Metastases
Principal Investigator: Raquibul Hannan, M.D., Ph.D.
Status: Pending Review
Contact: Susan Cooley, R.N.
Phone: 214-648-1895
susan.cooley@utsouthwestern.edu

Advanced RCC - Prior Treatment

A Phase II Trial of High Dose IL-2 and Stereotactic Ablative Body Radiation Therapy (SABR) for Patients with Metastatic Clear Cell Renal Cell Cancer (mRCC)
Clinical Trials.gov ID: NCT01896271
Principal Investigator: Raquibul Hannan, M.D., Ph.D.
Status: Recruiting
Contact: Susan Cooley, R.N.
Phone: 214-648-1895
Susan.Cooley@UTSouthwestern.edu

A Phase II Trial of Stereotactic Body Radiation Therapy in Combination with Nivolumab plus Ipilumimab in Patients with Metastatic Renal Cell Cancer
Clinical Trials.gov ID: NCT03065179
Principal Investigator: Hans Hammers, M.D., Ph.D.

Status: Recruiting
Contact: Allison Beaver, R.N.
Phone: 214-645-8789
allison.beaver@utsouthwestern.edu

A Phase I, Dose-Escalation Trial of PT2385 Tablets in Patients with Advanced Clear Cell Renal Cell Carcinoma
ClinicalTrials.gov ID: NCT02293980
Principal Investigator: Kevin Courtney, M.D., Ph.D.
Status: Ongoing, but completed recruitment
Contact: Jenny Chang
Phone: 214-648-6551
Jenny.Chang@UTSouthwestern.edu

A Phase I, Dose-Escalation Trial of PT2385 Tablets in Combination with Nivolumab in Patients with Advanced Clear Cell Renal Cell Carcinoma
ClinicalTrials.gov ID: NCT02293980
Principal Investigator: Kevin Courtney, M.D., Ph.D.

Status: Recruiting
Contact: Jenny Chang
Phone: 214-648-6551
Jenny.Chang@UTSouthwestern.edu

Phase II Randomized Trial of Nivolumab and Stereotactic Ablative Radiation Therapy (SAbR) Versus Nivolumab Alone for Metastatic Clear Cell Renal Cell Carcinoma
ClinicalTrials.gov ID: NCT02781506
Principal Investigator: Raquib Hannan, M.D., Ph.D.

Status: Recruiting
Contact: Susan Cooley, R.N.
Phone: 214-648-1895
Susan.Cooley@UTSouthwestern.edu

Phase I/II Study Exploring the Safety, Tolerability, and Efficacy of Pembrolizumab (MK-3475) in Combination with Epacadostat (INCB024360) in Subjects with Selected Cancers
Clinical Trials.gov ID: NCT02178722
Principal Investigator: Arthur Frankel, M.D.

Status: Recruiting
Contact: Pamela Kurian, M.S.
Phone: 214-648-5874
pamela.kurian@utsouthwestern.edu

A Phase I, Dose-Escalation Trial of PT2385 Tablets Plus Cabozantinib
Clinical Trials.gov ID: NCT02293980
Principal Investigator: Kevin Courtney, M.D.
Status: Recruiting
Contact: Jenny Chang
Phone: 214-648-6551
Jenny.Chang@UTSouthwestern.edu 

A Phase Ia/1b Study of FPA008 in Combination with Nivolumab in Patients with Selected Advanced Cancers
Clinical Trials.gov ID: NCT02526017
Principal Investigator: Muhammad Beg, M.D.
Status: Recruiting
Contact: Jenny Chang

Phone: 214-648-6551
Jenny.Chang@UTSouthwestern.edu 

Phase 1/1b Study to Evaluate the Safety and Tolerability of CPI-444 Alone and in Combination With Atezolizumab in Advanced Cancers
Clinical Trials.gov ID: NCT02655822
Principal Investigator: Arthur Frankel, M.D.
Status: Recruiting
Contact: Joyce Bolluyt
Phone: 214-648-7007
Joyce.Bolluyt@UTSouthwestern.edu

Phase II BMS FRACTION Study to Test Combination Treatments
Principal Investigator: Hans Hammers, M.D.
Status: Pending Review
Contact: Allison Beaver
Phone: 214-648-8789
Allison.Beaver@UTSouthwestern.edu

Advanced RCC - Prior PD1/PDL1

Phase 1/1b Study to Evaluate the Safety and Tolerability of CPI-444 Alone and in Combination With Atezolizumab in Advanced Cancers
Clinical Trials.gov ID: NCT02655822
Principal Investigator: Arthur Frankel, M.D.

Status: Recruiting
Contact: Joyce Bolluyt
Phone: 214-648-7007
Joyce.Bolluyt@UTSouthwestern.edu

Phase II BMS FRACTION Study to Test Combination Treatments
Principal Investigator: Hans Hammers, M.D.
Status: Pending Review
Contact: Allison Beaver
Phone: 214-648-8789
Allison.Beaver@UTSouthwestern.edu