This phase III trial compares nephrectomy (surgery to remove a kidney or part of a kidney)
with nivolumab to the usual approach of nephrectomy followed by standard post-operative
follow-up and monitoring, in treating patients with kidney cancer that is limited to a
certain part of the body (localized). Nivolumab is a drug that may help stimulate the immune
system to attack any cancer cells that may remain after surgery. The addition of nivolumab to
the usual surgery could prevent the cancer from returning. It is not yet known whether
nivolumab and nephrectomy is more effective than nephrectomy alone in treating patients with
I. To compare recurrence-free survival (RFS) between patients with renal cell carcinoma
randomly assigned to perioperative nivolumab in conjunction with radical or partial
nephrectomy with patients randomized to surgery alone.
I. To evaluate for differences in recurrence-free survival associated with perioperative
nivolumab compared to surgery alone among the subset of patients with clear cell histology.
II. To compare the overall survival between the two arms. III. To describe the safety and
tolerability of perioperative nivolumab.
I. To correlate the primary tumor's expression of programmed cell death 1 ligand 1 (PD-L1)
II. To correlate the expression of PD-L1 on tumor tissue at nephrectomy and recurrence with
III. To archive images for potential central confirmation of recurrence and for future
correlative work with American College of Radiology Imaging Network (ACRIN), including
markers predicting outcome or response.
IV. To prospectively collect tumor and biologic specimens (e.g., serum, peripheral blood
mononuclear cells [PBMCs]) for future correlative studies.
V. To characterize the pharmacokinetics of nivolumab and explore exposure response
relationships with respect to safety and efficacy.
VI. To characterize the immunogenicity of nivolumab.
QUALITY OF LIFE OBJECTIVE:
I. To evaluate differences in change from baseline in patient-reported symptoms and
toxicities among patients randomized to treatment with nivolumab compared to surgery alone.
OTHER EXPLORATORY OBJECTIVES:
I. To explore descriptively the efficacy of treatment with nivolumab in patients with
non-clear cell (including unclassified) histologies.
II. To characterize the effects of nivolumab on bone metabolism and bone density.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive nivolumab intravenously (IV) over 30 minutes on day 1. Treatment
repeats every 14 days for 2 cycles. Patients then undergo partial or radical nephrectomy 7-28
days later. Patient then receive nivolumab over 30 IV on day 1. Treatment repeats every 14
days for 6 cycles, and then every 28 days for 6 cycles in the absence of disease progression
or unacceptable toxicity.
Patients enrolled after Amendment 4 receive nivolumab IV over 30 minutes on day 1. Patients
then undergo partial or radical nephrectomy 7-28 days later. Patients then receive nivolumab
IV over 30 minutes on day 1. Treatment repeats every 4 weeks for up to 9 cycles in the
absence of disease progression or unacceptable toxicity.
ARM II: Patients undergo partial or radical nephrectomy within 8 weeks after registration
followed by observation.
After completion of study treatment, patients are followed up every 3 months for 2 years,
every 6 months for 3 years, and every 12 months for 5 years.
Malignant neoplasm of kidney,
Renal Cell Carcinoma,
Metastatic Malignant Neoplasm in the Soft Tissues,
Metastatic Renal Cell Carcinoma,
Stage III Renal Cell Cancer AJCC v7,
Metastatic Malignant Neoplasm in the Lung,
Stage II Renal Cell Cancer AJCC v7,
Unclassified Renal Cell Carcinoma,
Metastatic Malignant Neoplasm in the Lymph Nodes,
Metastatic Kidney Cancer,
Metastatic Malignant Neoplasm in Lymph Node,
Metastatic Malignant Neoplasm in the Adrenal Gland,
Metastatic Malignant Neoplasm in the Pancreas,
Metastatic Malignant Neoplasm in the Skin,
Renal Cell Cancer,
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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