June 2016 VOL 7, NO 5

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Clinical Trials Tracker

Select Ongoing Trials Currently Enrolling Patients with Kidney Cancers

The following are a selection of key clinical trials that are currently recruiting patients for inclusion in investigations of new therapies or new combinations of available therapies for patients with kidney cancer, including renal cell carcinoma. 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. Safety Trial of Nivolumab in Patients with Advanced or Metastatic Renal Cell Carcinoma (CheckMate 374)

This open-label, single-group phase 3b/4 clinical trial will assess the safety of nivolumab monotherapy in patients with advanced renal cell carcinoma, including high-grade immune-mediated adverse events. In addition to continuing the investigation of safety in patients with renal cell carcinoma with clear cell histology and previous treatment with anti–vascular endothelial growth factor therapy, this study will explore the safety and efficacy data for patients with non–clear cell histology and patients with histology or brain metastases. Men and women aged ≥18 years with predominantly clear cell histology and non–clear cell histology and a Karnofsky Performance Status score of ≥70% may be eligible for enrollment if other criteria are met. Eligible patients will receive nivolumab.

The primary outcome measure is the incidence of high-grade (grades 3-4 and grade 5) immune-mediated adverse events in patients with advanced renal cell carcinoma. The secondary outcome measures include the percentage of patients who receive hormone replacement therapy for the immune-mediated event, percentage of patients who receive ≥40 mg of prednisone equivalents for the immune-mediated event, and the total duration of all immune-modulating medications given for the immune-mediated event. This study plans to enroll 150 patients at multiple locations across the United States. For more information, contact Clinical.Trials@bms.com. The NLM Identifier is NCT02596035.

2. Pazopanib Hydrochloride in Patients with Metastatic Kidney Cancer with No Evidence of Disease After Surgery

This phase 3, randomized, double-blind clinical trial is assessing the efficacy of pazopanib hydrochloride compared with placebo in patients with kidney cancer that has spread to other parts of the body and who have no evidence of disease after surgery. Men and women aged ≥18 years with pathologically confirmed renal cell carcinoma with a clear cell component and those who have undergone nephrectomy or partial nephrectomy to remove primary renal cell carcinoma may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive pazopanib hydrochloride or placebo.

The primary outcome measure is disease-free survival. Some of the secondary outcome measures include change in fatigue, change in kidney cancer–related symptoms, overall survival, and toxicity. This study plans to enroll 128 patients at multiple locations across the United States. For more information, contact Leonard J. Appleman at 412-647-8073. The NLM Identifier is NCT01575548.

3. Immediate Surgery or Surgery After Sunitinib Malate in Treating Patients with Metastatic Kidney Cancer

The purpose of this phase 3, open-label, randomized study is to assess the efficacy of immediate surgery versus surgery after sunitinib malate in patients with metastatic kidney cancer. Men and women aged ≥18 years with histologically confirmed renal cell carcinoma and a WHO performance status score of 0 to 1 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to surgery followed by sunitinib malate or to sunitinib followed by surgery and then sunitinib.

The primary outcome measure is overall progression-free survival. The secondary outcome measures include overall survival; morbidity; overall response to treatment in the deferred nephrectomy arm, including the proportion of patients who become unresectable; and the effect of nephrectomy on early progression in the 2 study arms. This study expects to enroll 458 patients at multiple locations outside the United States. For more information, contact Julie Hermans at julie.hermans@eortc.be. The NLM Identifier is NCT01099423.

4. Nivolumab Combined with Ipilimumab versus Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 214)

This phase 3, randomized, open-label clinical trial compares progression-free survival and overall survival associated with nivolumab combined with ipilimumab versus sunitinib monotherapy in patients with previously untreated renal cell carcinoma. Men and women aged ≥18 years with histologically confirmed renal cell carcinoma with a clear cell component and advanced or metastatic renal cell carcinoma may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive nivolumab plus ipilimumab or sunitinib monotherapy.

The primary outcome measures are progression-free survival and overall survival. The secondary outcome measures include objective response rate and the incidence of adverse events. This study plans to enroll 1070 patients at multiple locations across the United States and abroad. For more information, e-mail Clinical.Trials@bms.com. The NLM Identifier is NCT02231749.

5. Everolimus in Treating Patients with Kidney Cancer Who Have Undergone Surgery

This randomized, double-blind, phase 3 clinical trial is evaluating the efficacy of everolimus in patients with kidney cancer who have undergone surgery. Men and women aged ≥18 years with histologically or cytologically confirmed renal cell carcinoma and a Zubrod score of 0 to 1 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to everolimus or placebo.

The primary outcome measure is recurrence-free survival. The secondary outcome measures include overall survival and toxicity. This study expects to enroll 1537 patients across multiple locations in the United States and Puerto Rico. For more information, contact Jennifer Scott at 210-614-8808, ext 1007, or jscott@swog.org; or Dana Sparks at 210-614-8808, ext 1004, or dsparks@swog.org. The NLM Identifier is NCT01120249.

6. Adjuvant Axitinib Therapy of Renal Cell Cancer in High-Risk Patients

This randomized, double-blind, parallel-assignment, phase 3 clinical trial is assessing whether adjuvant therapy with axitinib will prevent or delay the recurrence of renal cell carcinoma after surgery to remove the primary tumor in high-risk patients. Men and women aged ≥18 years with no evidence of macroscopic residual disease or metastatic disease who have not received previous systemic treatment for renal cell carcinoma may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to axitinib or placebo.

The primary outcome measure is disease-free survival. The secondary outcome measures include overall survival and safety. This study plans to enroll 700 patients at multiple locations across the United States and abroad. For more information, contact Rolf Linke, MD, at 925-223-6233, or atlas_medical_monitoring@sfj-pharma.com; or Stewart Hallett at 925-223-6233, or stewart.hallett@sfj-pharma.com. The NLM Identifier is NCT01599754.

7. Atezolizumab in Combination with Bevacizumab versus Sunitinib in Patients with Untreated Advanced Renal Cell Carcinoma

The purpose of this phase 3, randomized, parallel-assignment, open-label clinical trial is to evaluate the efficacy of atezolizumab (anti–PD-1 ligand 1 antibody) plus bevacizumab versus sunitinib in patients with inoperable, locally advanced or metastatic renal cell carcinoma who have not received previous systemic active or experimental therapy in the adjuvant or metastatic setting. Men and women aged ≥18 years with a Karnofsky Performance Status score of ≥70% and adequate hematologic and end-organ function may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to atezolizumab plus bevacizumab or sunitinib.

The primary outcome measure is progression-free survival. The secondary outcome measures include overall survival, objective response rate, safety, and time to deterioration. This study expects to enroll 830 patients at multiple locations across the United States and abroad. For more information, call 888-662-6728 or e-mail global.rochegenentechtrials@roche.com. The NLM Identifier is NCT02420821.

8. First-Line Pazopanib in Poor-Risk Patients with Metastatic Renal Cell Carcinoma

This phase 4, single-assignment, open-label clinical trial is evaluating the safety and efficacy of pazopanib in the first-line treatment of poor-risk patients with locally advanced or metastatic renal cell carcinoma. Men and women aged ≥18 years with histologically confirmed metastatic or locally advanced, predominantly clear cell renal cell carcinoma, and with a Karnofsky Performance Status score of ≥60% may be eligible for enrollment if other criteria are met. Eligible patients will receive pazopanib.

The primary outcome measure is the rate of poor-risk patients, as defined by the Memorial Sloan Kettering Cancer Center criteria for patients who are free of disease progression at 6 months after the start of first-line treatment with pazopanib. The secondary outcome measures include the number, characteristics, and severity of adverse events; progression-free survival; overall response rate and duration of response; relation between biomarkers and clinical outcome; and overall survival of poor-risk patients who receive pazopanib. This study plans to enroll 80 patients across multiple locations in Germany. For more information, e-mail info@iomedico.com. The NLM Identifier is NCT01521715.

9. Axitinib in Patients with Metastatic Non–Clear Cell Renal Cell Carcinoma Previously Treated with Temsirolimus

This open-label, single-group assignment, phase 2 clinical trial is evaluating the efficacy of axitinib in patients with metastatic non–clear cell renal cell carcinoma previously treated with temsirolimus. There is no standard treatment option for non–clear cell renal cell carcinoma, and axitinib is expected to be more effective than sorafenib or sunitinib in renal cell carcinoma. Men and women aged ≥18 years with histologically or cytologically confirmed renal cell carcinoma without a clear cell histologic component, with an ECOG performance status score of 0 or 1, and who previously received temsirolimus may be eligible for enrollment if other criteria are met. Eligible patients will receive axitinib.

The primary outcome measure is progression-free survival. The secondary outcome measures include response rate, disease control rate, overall survival, and safety. This study expects to enroll 41 patients in Korea. For more information, contact Se-Hoon Lee, MD, at shlee119@snu.ac.kr. The NLM Identifier is NCT01798446.

10. CyberKnife Radiosurgery for Rena Cell-Carcinoma

The purpose of this open-label, single-group assignment, phase 2 clinical trial is to evaluate the efficacy of CyberKnife-based radiosurgery in patients with renal cell carcinoma. CyberKnife-based radiosurgery is a way to deliver large doses of radiation very accurately to a tumor. Currently, radiosurgery is often used for brain metastases, stage I lung cancer, spine tumors, and localized prostate cancer. Men and women aged ≥18 years with histologic or radiologic evidence of stage I renal cell carcinoma, an ECOG performance status score of ≤2, and a life expectancy of ≥12 months may be eligible for enrollment if other criteria are met. Eligible patients will undergo CyberKnife radiosurgery.

The primary outcome measure is freedom from local tumor progression at 6 months in patients who undergo CyberKnife radiosurgery for primary renal tumors. The secondary outcome measures include quality of life and the incidence of adverse events. This study plans to enroll 46 patients in Massachusetts. For more information, contact Irving D. Kaplan, MD, at 617-667-2345, or ikaplan@caregroup.harvard.edu; or Nordine Benhaga, MD, at 617-667-4679, or nbenhaga@bidmc.harvard.edu. The NLM Identifier is NCT01890590.

11. Vandetanib in Combination with Metformin in Patients with Advanced Kidney Cancer or Sporadic Papillary Renal Cell Carcinoma

The purpose of this open-label, parallel-assignment, nonrandomized, phase 1/2 clinical trial is to evaluate the efficacy and safety of vandetanib plus metformin in patients with advanced hereditary leiomyomatosis and renal cell carcinoma, succinate dehydrogenase renal cell carcinoma, or advanced papillary renal cell carcinoma not related to a hereditary syndrome. Men and women aged ≥18 years with an ECOG performance status score of <2 may be eligible for enrollment if other criteria are met. The study will include 3 cohorts of patients—patients with advanced hereditary leiomyomatosis and renal cell carcinoma, patients with succinate dehydrogenase renal cell carcinoma, and patients with advanced papillary renal cell carcinoma—and all patients will receive a combination of vandetanib with metformin.

The primary outcome measure in phase 1 is to establish the safety and maximum tolerated dose of vandetanib and metformin when used in combination in patients with metastatic renal cell carcinoma. The primary outcome measure in phase 2 is to determine the overall response rate. This study plans to enroll 73 patients in Maryland. For more information, contact Martha Ninos, RN, at 301-496-6353, or mninos@mail.nih.gov. The NLM Identifier is NCT02495103.

12. Efficacy and Safety of Bevacizumab plus Sorafenib for the Third-Line Treatment in Patients with Metastatic Renal Cancer

The purpose of this randomized, open-label, parallel-assignment, phase 2 clinical trial is to compare the efficacy and safety of bevacizumab plus sorafenib versus sorafenib for the third-line treatment of patients with metastatic renal cell carcinoma. Men and women aged 18 to 75 years with histologically or pathologically advanced renal cell carcinoma and an ECOG performance status score of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will receive bevacizumab plus sorafenib or sorafenib.

The primary outcome measure is progression-free survival. The secondary outcome measures are overall survival and safety. This study plans to enroll 106 patients in China. For more information, contact Xinan Sheng, MD, at doctor_sheng@126.com; or Jun Guo, MD, PhD, at guoj307@126.com. The NLM Identifier is NCT02330783.

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