NCT02210117

Nivolumab With or Without Bevacizumab or Ipilimumab Before Surgery in Treating Patients With Metastatic Kidney Cancer That Can Be Removed by Surgery

A Pilot Randomized Tissue-Based Study Evaluating Anti-PD1 Antibody or Anti-PD1 + Bevacizumab or Anti-PD1 + Anti-CTLA-4 in Patients With Metastatic Renal Cell Carcinoma Who Are Eligible for Cytoreductive Nephrectomy, Metastasectomy or Post-Treatment Biopsy

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized pilot early phase I trial studies the side effects and how well nivolumab alone works compared to nivolumab with bevacizumab or ipilimumab before surgery in treating patients with kidney cancer, also referred to as renal cell cancer, that has spread to another place in body and can be removed by surgery. Immunotherapy with monoclonal antibodies, such as nivolumab, bevacizumab, and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Detailed description

PRIMARY OBJECTIVES: I. Safety and tolerability of therapy with nivolumab or nivolumab + bevacizumab or nivolumab + ipilimumab in metastatic renal cell carcinoma (mRCC) in the context of presurgical or prebiopsy therapy. SECONDARY OBJECTIVES: I. To study immunological changes in tumor tissues and peripheral blood in response to nivolumab versus (vs.) nivolumab + bevacizumab vs nivolumab + ipilimumab in renal cell carcinoma (RCC) therapy. II. To assess the efficacy of presurgical nivolumab or nivolumab + bevacizumab or nivolumab + ipilimumab therapy in RCC by evaluating objective response rate, duration of response, and progression free survival, and overall survival. OUTLINE: Patients are randomized to 1 of 3 treatment arms. ARM A: Patients receive nivolumab intravenously (IV) over 60 minutes on day 1 every 2 weeks for 6 weeks. Approximately 4 weeks later, patients undergo nephrectomy, metastasectomy or biopsy. ARM B: Patients receive nivolumab IV over 60 minutes and bevacizumab IV over 90 minutes on day 1 every 2 weeks for 6 weeks. Patients also undergo nephrectomy, metastasectomy or biopsy as in Arm A. ARM C: Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes on day 1 every 3 weeks for 6 weeks. Patients also undergo nephrectomy, metastasectomy or biopsy as in Arm A. Beginning 4-6 weeks after surgery, patients in all arms who have clinical response, stable disease, or even slight progression of disease to therapy preoperatively, receive maintenance nivolumab IV over 60 minutes on day 1. Cycles repeat every 4 weeks for 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and 86 days, every 3 months for 2 years, every 6 months for 1 year, and then annually thereafter.

Conditions

• Clear Cell Renal Cell Carcinoma
• Metastatic Kidney Carcinoma
• Stage IV Renal Cell Cancer AJCC v7

Interventions

Type	Name	Description
BIOLOGICAL	Bevacizumab	Given IV
PROCEDURE	Biopsy	Undergo biopsy
BIOLOGICAL	Ipilimumab	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
PROCEDURE	Metastasectomy	Undergo metastasectomy
BIOLOGICAL	Nivolumab	Given IV
PROCEDURE	Therapeutic Conventional Surgery	Undergo nephrectomy

Timeline

• Start date: 2014-11-25
• Primary completion: 2026-11-30
• Completion: 2026-11-30
• First posted: 2014-08-06
• Last updated: 2026-01-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study