Clinical trial NCT02210117: Nivolumab With or Without Bevacizumab or Ipilimumab Before Surgery in Treating Patients With Metastatic Kidney Cancer That Can Be Removed by Surgery
Official title: 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
Conditions: Clear Cell Renal Cell Carcinoma
Metastatic Kidney Carcinoma
Stage IV Renal Cell Cancer AJCC v7
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.
Interventions:
description: Given IV
name: Bevacizumab
other_name: Anti-VEGF
Anti-VEGF Humanized Monoclonal Antibody
Anti-VEGF rhuMAb
Avastin
BEVACIZUMAB, LICENSE HOLDER UNSPECIFIED
Bevacizumab Biosimilar BEVZ92
Bevacizumab Biosimilar BI 695502
Bevacizumab Biosimilar CBT 124
Bevacizumab Biosimilar FKB238
Bevacizumab Biosimilar MIL60
Bevacizumab Biosimilar QL 1101
Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer
Recombinant Humanized Anti-VEGF Monoclonal Antibody
rhuMab-VEGF
type: Biological
description: Undergo biopsy
name: Biopsy
other_name: Bx
type: Procedure
description: Given IV
name: Ipilimumab
other_name: Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody
BMS-734016
MDX-010
MDX-CTLA4
Yervoy
type: Biological
description: Correlative studies
name: Laboratory Biomarker Analysis
type: Other
description: Undergo metastasectomy
name: Metastasectomy
type: Procedure
description: Given IV
name: Nivolumab
other_name: BMS-936558
MDX-1106
NIVO
ONO-4538
Opdivo
type: Biological
description: Undergo nephrectomy
name: Therapeutic Conventional Surgery
type: Procedure
Study arms:
design_group_description: Patients receive nivolumab IV over 60 minutes on day 1 every 2 weeks for 6 weeks. Approximately 4 weeks later, patients undergo nephrectomy, metastasectomy or biopsy.<br/>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.
design_group_title: Arm A (nivolumab, surgery)
design_group_type: Experimental
design_group_description: 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.<br/>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.
design_group_title: Arm B (nivolumab, bevacizumab, surgery)
design_group_type: Experimental
design_group_description: 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.<br/>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.
design_group_title: Arm C (nivolumab, ipilimumab, surgery)
design_group_type: Experimental
Sponsor: The University of Texas MD Anderson Cancer Center
Collaborators: National Cancer Institute
Drug name mappings:
name: 伊匹木单抗
lang: CN
name: Ipilimumab
lang: EN
name: イピリムマブ（遺伝子組換え）
lang: JP
name: 纳武利尤单抗
lang: CN
name: Nivolumab
lang: EN
name: ニボルマブ（遺伝子組換え）
lang: JP
name: 贝伐珠单抗
lang: CN
name: Bevacizumab
lang: EN
name: ベバシズマブ（遺伝子組換え）
lang: JP