Nivolumab With or Without Bevacizumab or Ipilimumab Before Surgery in Treating Patients With Metastatic Kidney Cancer That Can Be Removed by Surgery
NCT02210117 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 104
Last updated 2026-01-07
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.
Conditions
- Clear Cell Renal Cell Carcinoma
- Metastatic Kidney Carcinoma
- Stage IV Renal Cell Cancer AJCC v7
Interventions
- BIOLOGICAL
-
Given IV
- PROCEDURE
-
Biopsy
Undergo biopsy
- BIOLOGICAL
-
Given IV
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
- PROCEDURE
-
Metastasectomy
Undergo metastasectomy
- BIOLOGICAL
-
Given IV
- PROCEDURE
-
Therapeutic Conventional Surgery
Undergo nephrectomy
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Padmanee Sharma · M.D. Anderson Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-11-25
- Primary Completion
- 2026-11-30
- Completion
- 2026-11-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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