The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies that are focused on several different kinds of treatments for kidney cancer. These trials are evaluating gene therapy, immunotherapy, chemotherapy, radiotherapy, and combinations thereof.
All of the studies listed below are on the National Institutes of Health website at ClinicalTrials.gov.
PHASE I
Study Title: A Phase I Study of HERV-E TCR Transduced Autologous T Cells in Patients With Metastatic Clear Cell Renal Cell Carcinoma
Study Type: Interventional/single-group assignment
Study Sponsor and Collaborators: National Heart, Lung, and Blood Institute/Loyola University Medical Center
Purpose: To determine whether the infusion of HERV-E TCR transduced CD8-positive/CD34-positive enriched T cells is safe and whether it can cause metastatic renal cell carcinoma tumors to shrink
Primary Outcome Measures: Toxicity [time frame: 21 days]
Principal Investigator: Richard Childs, MD, National Heart, Lung, and Blood Institute; contact Kristen Wood, RN, (301) 827-2977, kristen.gunn@nih.gov
ClinicalTrials.gov Identifier: NCT03354390
Study Title: A Pilot Study of Preoperative Nivolumab in High-Risk Nonmetastatic and Metastatic Renal Cell Carcinoma
Study Type: Interventional/single-group assignment
Study Sponsor and Collaborators: National Cancer Institute
Purpose: To determine the side effects of nivolumab and how well it works in treating patients with high-risk kidney cancer before surgery
Primary Outcome Measures: Feasibility of a patient to receive at least 3 doses of nivolumab and complete surgery without significant delay attributable to nivolumab therapy [time frame: up to 8 weeks]. Significant delay is defined as delay of more than 112 days after the first dose of nivolumab.
Principal Investigator: Martin Voss, Memorial Sloan Kettering Cancer Center; contact (212) 639-7202, vossm@mskcc.org
ClinicalTrials.gov Identifier: NCT02595918
Study Title: Phase I/II Trial of Vandetanib in Combination With Metformin in Subjects With Hereditary Leiomyomatosis and Renal Cell Cancer or Succinate Dehydrogenase–Associated Kidney Cancer or Sporadic Papillary Renal Cell Carcinoma
Study Type: Interventional/sequential assignment
Study Sponsor and Collaborators: National Cancer Institute
Purpose: To test the combination of metformin and vandetanib in people with advanced kidney cancer and determine a safe dosage for the drugs
Primary Outcome Measures: The maximum tolerated dose and a list of adverse events frequencies in reaction to the combination of vandetanib and metformin in patients with metastatic renal cell carcinoma [time frame: 42 days after the last patient starts therapy]
Principal Investigator: Ramaprasad Srinivasan, MD, National Cancer Institute; contact Laura Wisch, RN, (301) 480-6194, laura.wisch@nih.gov
ClinicalTrials.gov Identifier: NCT02495103
PHASE II
Study Title: A Phase II Trial of Stereotactic Ablative Body Radiation Therapy for Patients With Primary Renal Cancer
Study Type: Interventional/single-group assessment
Study Sponsor and Collaborators: UT Southwestern Medical Center
Purpose: To evaluate the efficacy of stereotactic radiation therapy for biopsy-proven and growing small renal tumors
Primary Outcome Measures: To evaluate whether stereotactic radiation therapy to small renal tumors is able to eliminate cancerous growth and tumor viability [time frame: 2 years]
Principal Investigator: Raquibul Hannan, MD, PhD, UT Southwestern; contact (214) 645-8525
ClinicalTrials.gov Identifier: NCT02141919
Study Title: Phase II Trial of Stereotactic Body Radiation Therapy in Combination With Nivolumab Plus Ipilimumab in Patients With Metastatic Renal Cell Cancer
Study Type: Interventional/single-group assignment
Study Sponsor and Collaborators: UT Southwestern Medical Center
Purpose: To determine the safety and efficacy of the combination of nivolumab plus ipilimumab and stereotactic body radiation therapy in patients with metastatic renal cell carcinoma
Primary Outcome Measures: The number of participants with treatment-related adverse events of special interest assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [time frame: 1 year]
Principal Investigator: Hans Hammers, MD, PhD, UT Southwestern Medical Center; contact (214) 645-7445, Hans.Hammers@utsouthwestern.edu
ClinicalTrials.gov Identifier: NCT03065179
PHASE III
Study Title: A Phase III Randomized Study Comparing Perioperative Nivolumab vs Observation in Patients With Localized Renal Cell Carcinoma Undergoing Nephrectomy
Study Type: Interventional/parallel assignment
Study Sponsor and Collaborators: National Cancer Institute/Canadian Cancer Trials Group
Purpose: To compare nephrectomy with and without nivolumab in treating patients with localized kidney cancer
Primary Outcome Measures: Recurrence-free survival [time frame: time from randomization to disease recurrence or death from any cause, assessed up to 10 years]
Principal Investigator: Lauren Harshman, ECOG-ACRIN Cancer Research Group
ClinicalTrials.gov Identifier: NCT03055013 ■
Editor’s Note: The clinical trials presented here do not represent all the trials listed on ClinicalTrials.gov. For the complete list, go to ClinicalTrials.gov.
