Nivolumab in Treating Patients With Localized Kidney Cancer Undergoing Nephrectomy

Titre officiel

A Phase 3 Randomized Study Comparing Perioperative Nivolumab vs. Observation in Patients With Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)

Sommaire:

Cette étude de phase III compare la néphrectomie (ablation chirurgicale d’un rein ou d’une partie d’un rein) avec ou sans nivolumab dans le traitement de patients atteints d’un cancer du rein limité à une certaine partie du corps (localisé). L’immunothérapie au moyen d’anticorps monoclonaux, comme le nivolumab, peut aider le système immunitaire de l’organisme à attaquer le cancer et peut entraver la capacité des cellules tumorales à croître et à se propager. L’administration de nivolumab avant une néphrectomie peut réduire la taille de la tumeur et diminuer la quantité de tissu normal à retirer, tandis qu’après une néphrectomie, elle peut augmenter la survie. On ignore encore si le nivolumab et la néphrectomie sont plus efficaces que la néphrectomie seule dans le traitement du cancer du rein.

Description de l'essai

Primary Outcome:

  • Recurrence-free survival (RFS)
Secondary Outcome:
  • Overall survival
  • RFS among patients with clear cell cancer
  • Incidence of toxicity
PRIMARY OBJECTIVES:
  • 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:
  • 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. 
  • To compare the overall survival between the two arms. 
  • To describe the safety and tolerability of perioperative nivolumab. 
CORRELATIVE OBJECTIVES:
  • To correlate the primary tumour's expression of programmed cell death 1 ligand 1 (PD-L1) with outcome. 
  • To correlate the expression of PD-L1 on tumour tissue at recurrence with outcome. 
  •  To archive images for central confirmation of recurrence and for future correlative work with American College of Radiology Imaging Network (ACRIN), including markers predicting outcome or response. 
  •  To prospectively collect tumour and biologic specimens (e.g., serum, peripheral blood mononuclear cells [PBMCs]) for future correlative studies. 
  •  To characterize the pharmacokinetics of nivolumab and explore exposure response relationships with respect to safety and efficacy. 
  •  To characterize the immunogenicity of nivolumab. 
QUALITY OF LIFE OBJECTIVES:
  • 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:
  • To explore descriptively the efficacy of treatment with nivolumab in patients with non-clear cell (including unclassified) histologies. 
  • 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 30-60 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 30-60 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 30-60 minutes on day 1. Patients then undergo partial or radical nephrectomy 7-28 days later. Patient then receive nivolumab IV over 30-60 minutes on day 1. Treatment repeats every 4 weeks for 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.

Voir cet essai sur ClinicalTrials.gov

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