Select Ongoing Trials Currently Enrolling Patients with Renal-Cell Carcinoma

February 2017, Vol 7, No 2 - Clinical Trials Tracker


The following studies represent a selection of key clinical trials that are currently recruiting patients with renal-cell carcinoma (RCC) for inclusion in investigations of new therapies or new combinations of available ther­apies for patients with kidney cancer. Each trial description includes the NLM Identifier to be used as a reference with ClinicalTrials.gov. The information below can help oncology practice managers and providers direct their eligible patients to one of these clinical trials.

1 Sunitinib Schedule 4/2 versus Sunitinib Schedule 2/1 as First-Line Therapy in Metastatic RCC

This randomized, open-label, parallel-group assignment, phase 2 clinical trial will determine whether sunitinib (Sutent) 50 mg daily using a 2 weeks on and 1 week off regimen could provide the same efficacy in terms of progression-free survival (PFS), objective response, and overall survival (OS), while reducing drug-related toxicity, as a sunitinib regimen of 4 weeks of treatment and 2 weeks off. Men and women aged 18 to 75 years who are treatment-naïve at diagnosis and have an Eastern Cooperative Oncology Group (ECOG) performance scale of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will receive a sunitinib 50-mg daily schedule 4/2 or a sunitinib 50-mg daily schedule 2/1.

The primary outcome measure is PFS. The secondary outcome measure is the percentage of patients who can reach complete response and partial response. The other outcome measure is the number of adverse events. This study plans to enroll 80 patients in China. For more information, contact Chuanliang Cui, MD, at 1008ccl@163.com, or Jun Guo, MD, PhD, at guoj307@126.com. The NLM Identifier is NCT02398552.

2 Real-Life Efficacy and Safety of Nivolumab in Advanced RCC After Previous Therapy

The purpose of this observational study is to evaluate the efficacy and safety of nivolumab (Opdivo) in patients with advanced RCC after previous therapy. Men and women aged ≥18 years with a diagnosis of advanced RCC may be eligible for enrollment if other criteria are met. The study will assess patients who are initiating nivolumab for the first time.

The primary outcome measure is OS. The secondary outcome measures include PFS, overall response rate, best overall response rate, best overall response, distribution of sociodemographic and clinical characteristics in adult patients with advanced RCC who are initiating nivolumab treatment, distribution of incidence of adverse events, distribution of severity of adverse events, distribution of management of adverse events, functional assessment of cancer therapy, quality of life, distribution of RCC treatment history, and distribution of treatment patterns. This study expects to enroll 323 patients in Germany. For more information, e-mail Clinical.Trials@bms.com. The NLM Identifier is NCT02940639.

3 Alternating Sunitinib and Bevacizumab in Advanced RCC: The CASA Clinical Trial

This phase 1/2, open-label, single-group assignment is assessing the safety and efficacy of combined sunit­inib and bevacizumab (Avastin) in advanced RCC. Men and women aged 18 to 85 years with histologically confirmed RCC and clear-cell histology whose ECOG performance status is 0-2 may be eligible for enrollment if other criteria are met. Eligible patients will receive sunit­inib and bevacizumab.

The primary outcome measure is bevacizumab maximum tolerated dose, response rate, and PFS. The secondary outcome measures include OS and number of participants with treatment-related adverse effects. This study plans to enroll 77 patients in Saudi Arabia. For more information, contact Shouki Bazarbashi, MD, at bazarbashi@kfshrc.edu.sa, or Fazal Hussain, MD, at fhussain@kfshrc.edu.sa. The NLM Identifier is NCT02919371.

4 AGS-16C3F versus Axitinib in Metastatic RCC

The purpose of this phase 2, randomized, open-label, parallel-assignment study is to evaluate the PFS, based on investigator radiologic review, of AGS-16C3F compared with axitinib (Inlyta) in patients with metastatic RCC. Men and women aged ≥18 years with histologically confirmed metastatic RCC whose ECOG performance status is 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will receive AGS-16C3F or axitinib.

The primary outcome measure is PFS. The secondary outcome measures include PFS based on central radiology assessment, objective response rate, duration of response, OS, disease control rate, and safety. This study expects to enroll 134 patients at multiple locations across the United States and Canada. For more information, contact Agensys Clinical Research and Development at 424-280-5000 or Astellas.registration@astellas.com. The NLM Identifier is NCT02639182.

5 Everolimus in Patients with Advanced RCC

This phase 4, open-label, single-group assignment will assess the efficacy of everolimus (Afinitor) in patients with advanced RCC. Men and women aged ≥18 years with a life expectancy of at least 3 months whose Karnofsky performance status is ≥70 may be eligible for enrollment if other criteria are met. Eligible patients will receive everolimus.

The primary outcome measure is the PFS rate. The secondary outcome measures include disease control state, objective response rate, and safety profile. This study plans to enroll 110 patients at multiple locations abroad. For more information, contact Novartis Pharmaceuticals at +41613241111. The NLM Identifier is NCT01206764.

6 Lenvatinib plus Everolimus or Lenvatinib plus Pembrolizu­mab versus Sunitinib Alone for Advanced RCC

This randomized, open-label, parallel-assignment, phase 3 clinical trial compares the efficacy and safety of lenvatinib (Lenvima) in combination with everolimus or pembroliz­umab (Keytruda) versus sunitinib as first-line treatment in participants with advanced RCC. Men and women aged ≥18 years with at least 1 measurable target lesion and with a Karnofsky performance status of at least 70 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive lenvatinib plus everolimus, lenvatinib plus pembrolizumab, or sunitinib.

The primary outcome measure is PFS. The secondary outcome measures include objective response rate, OS, and number of treatment-emergent adverse events. This study expects to enroll 735 patients in Illinois and South Carolina. For more information, contact Eisai Medical Information at 888-274-2378. The NLM Identifier is NCT02811861.

7 Axitinib and TRC105 versus Axitinib Alone for Advanced or Metastatic RCC

The goal of this randomized, open-label, parallel-assignment, phase 1b/2 clinical trial is to (1) evaluate the safety and tolerability and determine a recommended phase 2 dose for TRC105 when added to standard-dose axitinib therapy in patients with advanced RCC; and (2) estimate the PFS of patients with advanced or metastatic RCC by RECIST version 1.1 criteria in patients who received axi­tinib and TRC105 compared with patients who received axitinib alone, following nonresponse to 1 previous vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI).

Men and women aged ≥18 years with histologically confirmed advanced or metastatic RCC with a clear-cell component that has progressed after treatment with 1 multitargeted TKI other than axitinib that targets the VEGF receptor may be eligible for enrollment if other criteria are met. Eligible patients will receive TRC105 plus axitinib or axitinib alone.

The primary outcome measure in phase 1b of this trial is safety and tolerability, and PFS in phase 2. The secondary outcome measure in phase 1b is evidence of antitumor activity when TRC105 is added to axitinib. The secondary outcome measure in phase 2 is overall response rate. The study expects to enroll 168 patients at multiple locations across the United States and abroad. For more information, e-mail Clinicaltrials@traconpharma.com. The NLM Identifier is NCT01806064.

8 Atezolizumab plus Bevacizu­mab for Non–Clear-Cell RCC

The purpose of this phase 2, open-label, single-group assignment is to study the combination atezoliz­umab (Tecentriq) and bevacizumab as a potential treatment for advanced non–clear-cell RCC. Men and women aged ≥18 years with advanced or metastatic non–clear-cell RCC and with an ECOG performance status of ≤2 may be eligible for enrollment if other criteria are met. Eligible patients will receive atezolizumab plus bevacizumab.

The primary outcome measure is overall response rate. The secondary outcome measures include duration of response, treatment-related adverse events, immune-related objective response rate, PFS, OS, function assessment, and fatigue score. This study plans to enroll 40 patients in Massachusetts. For more information, contact Toni Choueiri, MD, at 617-632-5456 or Toni_Choueiri@dfci.harvard.edu. The NLM Identifier is NCT02724878.

9 Avelumab plus Axitinib versus Sunitinib in Advanced RCC: The JAVELIN Renal 101 Clinical Trial

The purpose of this phase 3, randomized, parallel-assignment, open-label clinical trial is to evaluate the antitumor activity and safety of avelumab in combination with axi­tinib versus sunitinib monotherapy, administered as first-line treatment, in patients with advanced RCC. Men and women aged ≥18 years with adequate bone marrow function and an ECOG performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will receive avelumab plus axitinib or sunitinib monotherapy.

The primary outcome measure is PFS. Some of the secondary outcome measures include OS, objective response rate, disease control, time to tumor response, duration of response, PFS by investigator assessment, and tumor tissue biomarker status. This study expects to enroll 583 patients at multiple locations across the United States and abroad. For more information, call Pfizer’s Oncology Clinical Trial Information Service at 800-718-1021. The NLM Identifier is NCT02684006.

10 Tivozanib Hydrochloride versus Sorafenib for Refractory Advanced RCC

This phase 3, randomized, open-label, parallel-assignment clinical trial is comparing tivozanib with sorafenib (Nexavar) in patients with refractory advanced RCC. Men and women aged ≥18 years whose disease did not respond to 2 or 3 previous systemic regimens and who have an ECOG performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will receive tivozanib hydrochloride or sorafenib.

The primary outcome measure is PFS. The secondary outcome measures include OS, objective response rate, and duration of response. This study plans to enroll 322 patients at multiple locations across the United States and abroad. For more information, e-mail Darlene Wilson at dwilson@aveooncology.com, or Michael Needle, MD, at mneedle@aveooncology.com. The NLM Identifier is NCT02627963.