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Poster display session

5094 - A phase 2 BIOmarker driven trial with Nivolumab and Ipilimumab or VEGFR tKi in naïve metastatic Kidney cancer: the BIONIKK trial

Date

10 Sep 2017

Session

Poster display session

Topics

Cytotoxic Therapy;  Immunotherapy;  Translational Research;  Renal Cell Cancer

Presenters

Reza Thierry Elaidi

Citation

Annals of Oncology (2017) 28 (suppl_5): v295-v329. 10.1093/annonc/mdx371

Authors

R.T. Elaidi1, S. Oudard2, E. Braychenko1, C. Sun3, C. Sautès-Fridman3, Y. Vano2

Author affiliations

  • 1 Medical Oncology, ARTIC - Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie, 75015 - Paris/FR
  • 2 Medical Oncology, Hopital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris-Descartes, 75015 - Paris/FR
  • 3 Cancer, Immune Control And Escape, INSERM1138, Paris/FR
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Resources

Abstract 5094

Background

Nine targeted agents have been approved for metastatic clear cell renal cell carcinoma (mccRCC) in the last 10 years, including VEGFR-tyrosine kinase inhibitors (TKI), mTOR inhibitors and checkpoint inhibitor (CI). Combination of CI nivolumab and ipilimumab is currently compared to sunitinib in a randomised phase III trial in first-line setting. While treatment opportunities of mccRCC are moving rapidly biomarker to select patients to receive TKI or CI are still lacking. Based on transcriptomic analysis, we have defined four distinct molecular groups (ccrcc1 to 4) in patients with mccRCC treated with sunitinib. These groups were mainly characterized by distinct responses to suntinib as well as distinct immune cell compositions and inhibitory receptor expressions.

Trial design

The proof of concept study BIONIKK is a French multicentric randomised phase II designed to assess the use of molecular groups to select treatment in first-line mccRCC. Molecular group is determined on frozen tumor sample within 2 weeks. Treatment is then allocated between TKI and nivolumab plus ipilimumab for ccrcc2 and 3 and between nivolumab alone and nivolumab plus ipilimumab for ccrcc1 and 4. Main objective is to assess efficacy of each treatment arm according to molecular group. Primary endpoint is overall response rate using RECIST 1.1. Main secondary endpoints include PFS, OS and their relationship to exploratory biomarkers. These latter include protein and gene expression analyses of tumor microenvironment (TME) from formalin-fixed and paraffin-embedded tumor samples. In addition, phenotype and functional status of peripheral blood lymphocytes will be analysed with flow cytometry before and during treatment. A Bayesian model was used to avoid independent analyses of the effect of drugs using hierarchical borrowing. Bionikk is not designed to be conclusive on the superiority of any treatment but will generate important hypotheses on putative biomarkers to select patients to receive TKI, CI alone or in combination. From this point of view, Bionikk is the first biomarker-driven trial in first line metastatic ccRCC.

Clinical trial identification

NCT02960906 First received: August 18, 2016

Legal entity responsible for the study

Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

Funding

Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie and Bristol-Myers Squibb

Disclosure

S. Oudard: Honorarium fees from Astellas, Pfizer, Sanofi, Janssen, Bristol-Myers Squibb. Y-A. Vano: Honorarium fees from Bristol-Myers Squibb, Pfizer, Novartis, Astellas, Sanofi, Janssen, Roche. All other authors have declared no conflicts of interest.

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