Nivolumab in Treating Patients With Localized Kidney Cancer Undergoing Nephrectomy

  • STATUS
    Recruiting
  • End date
    Nov 30, 2023
  • participants needed
    766
  • sponsor
    National Cancer Institute (NCI)
Updated on 20 June 2021
diabetes
platelet count
antibiotics
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tubal ligation
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monoclonal antibodies
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major surgery
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hormone therapy
primary tumor
brain metastases
conventional surgery
pd-l1
bone metastases
programmed cell death 1 ligand 1
nivolumab
cancer treatment
radiofrequency ablation
inhaled steroids
antineoplastic
a 12
renal function tests
kidney tumor
kidney cancer
renal function test
nephrectomy
metastasectomy
oncocytoma

Summary

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 kidney cancer.

Description

PRIMARY OBJECTIVE:

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.

SECONDARY OBJECTIVES:

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.

CORRELATIVE OBJECTIVES:

I. To correlate the primary tumor's expression of programmed cell death 1 ligand 1 (PD-L1) with outcome.

II. To correlate the expression of PD-L1 on tumor tissue at nephrectomy and recurrence with outcome.

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.

Details
Condition Adenocarcinoma, 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, Oligometastasis, 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, Malignant Adenoma, Renal Cell Cancer, Renal Cancer
Treatment conventional surgery, laboratory biomarker analysis, questionnaire administration, quality-of-life assessment, Nivolumab, pharmacological study, Patient Observation
Clinical Study IdentifierNCT03055013
SponsorNational Cancer Institute (NCI)
Last Modified on20 June 2021

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