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BIONIKK: A phase 2 biomarker driven trial with nivolumab and ipilimumab or VEGFR tyrosine kinase inhibitor (TKI) in naïve metastatic kidney cancer.
- Source :
-
Bulletin du cancer [Bull Cancer] 2020 Jun; Vol. 107 (5S), pp. eS22-eS27. - Publication Year :
- 2020
-
Abstract
- Background: The nivolumab-ipilimumab combination provides an overall response rate of 42% in first-line metastatic treatment of clear cell renal carcinoma (mccRCC). To date, there is no robust predictive biomarker of response to immune checkpoint inhibitor (ICI). In addition, severe autoimmune disorders occur more frequently with ICI combination than with ICI alone. The objective of this study is to compare the efficacy of ICI alone or in combination in patients according to tumor molecular characteristics.<br />Methods: Using a 35-gene expression mRNA signature, patients were divided into 4 molecular groups (1 to 4). Patients in groups 1 and 4 were randomized to receive nivolumab alone (arms 1A and 4A) or nivolumab plus ipilimumab for 4 injections followed by nivolumab alone (arms 1B and 4B). Patients in groups 2 and 3 were randomized to receive nivolumab plus ipilimumab followed by nivolumab alone (arms 2B and 3B) or a tyrosine kinase inhibitor (sunitinib or pazopanib at the investigator's choice (arms 2C and 3C)). The main objective is the overall response rate by treatment and molecular group.<br />Discussion: BIONIKK is the first trial in mccRCC to study the personalization of treatment with ICI or TKI according to tumor molecular characteristics in mccRCC. This trial is the most appropriate to prospectively identify biomarkers of response to nivolumab used alone or in combination or TKI monotherapy in patients with mccRCC. NCT02960906.<br /> (Copyright © 2020 Société Française du Cancer. Publié par Elsevier Masson SAS. Tous droits réservés.)
- Subjects :
- Biomarkers, Tumor
Drug Therapy, Combination
Humans
Indazoles
Kidney Neoplasms pathology
Neoplasm Metastasis
Receptors, Vascular Endothelial Growth Factor antagonists & inhibitors
Antineoplastic Agents, Immunological administration & dosage
Antineoplastic Combined Chemotherapy Protocols administration & dosage
Clinical Trials, Phase II as Topic methods
Ipilimumab administration & dosage
Kidney Neoplasms drug therapy
Nivolumab administration & dosage
Protein Kinase Inhibitors administration & dosage
Pyrimidines administration & dosage
Randomized Controlled Trials as Topic methods
Sulfonamides administration & dosage
Sunitinib administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1769-6917
- Volume :
- 107
- Issue :
- 5S
- Database :
- MEDLINE
- Journal :
- Bulletin du cancer
- Publication Type :
- Academic Journal
- Accession number :
- 32620212
- Full Text :
- https://doi.org/10.1016/S0007-4551(20)30283-6