IMmotion010


Protocolnummer:
NL60191.056.17

Ziekenhuizen:
Franciscus Gasthuis Rotterdam & Vlietland
NKI / A.v.L ziekenhuis Amsterdam
RadboudUMC Nijmegen
St. Antonius ziekenhuis Nieuwegein
Universitair Medisch Centrum Groningen
VU Medisch Centrum Amsterdam

Titel:

A phase III, multicenter, randomized, placebo-controlled, double-blind study of atezolizumab (anti- Pd-L1 antibody) as adjuvant therapy in patients with renal cell carcinoma at high risk of developing metastasis following nephrectomy.

Behandeling:

Stadium:

Belangrijkste in/exclusiecriteria:

Inclusie criteria:

  • Pathologically confirmed RCC with a component of either clear cell histology or sarcomatoid histology that has not been previously treated in the adjuvant or neoadjuvant setting
  • Localized disease with T2 Grade 4, T3a Grade 3-4, T3b/c any grade, T4 any grade and TxN+ any grade
  • Pulmonary (treated with sub-lobar or lobar resection), lymph node, or soft-tissue metachronous recurrence of disease occurring greater than 12 months following nephrectomy who undergo complete resection (R0; microscopically margin-negative resection in which no gross of microscopic disease remains) and have no evidence of disease following metastasectomy
  • patients with synchronous metastases who have undergone complete resection of residual disease are eligible in the following circumstances: isolated solitary adrenal metastasis treated

12-jan-2017

with adrenalectomy and lung metastases treatable with a sub-lobar or lobar resection at the

time of nephrectomy

  • Radical or partial nephrectomy with lymphadenectomy in select patients
  • Absence of residual disease and absence of metastasis
  • Full recovery from nephrectomy or metastasectomy within 12 weeks from randomization following surgery. Exclusion criteria:
  • Bilateral synchronous tumors with inheritable forms of RCC including von Hippel-Lindau
  • Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment
  • Treatment with any other investigational agent or participation in another clinical study
  • CNS metastases or leptomeningeal disease
  • Malignancies other than RCC within 5 years prior to Cycle 1, Day 1
  • Life expectancy of < 24 weeks
  • History of autoimmune disease, allogeneic stem cell or solid organ transplantation
  • Significant cardiovascular disease
  • a known LVEF < 40%
  • HIV Positive, active hepatitis B or hepatitis C, active tuberculosis
  • Severe infections within 4 weeks prior to randomization
  • Receipt of therapeutic oral or intravenous (IV) antibiotics within 2 weeks prior to randomization
  • Prior treatment with CD137 agonists, anti-CTLA-4, anti-programmed death-1 (PD-1), or anti-PD-L1 therapeutic antibody or pathway-targeting agents
  • Treatment with systemic immunostimulatory agents or treatment with systemic immunosuppressive medications

Contactpersoon:
Dr. A. Bex, NKI/AVL

Alle niercelcarcinoom trials