BIONIKK: A phase 2 biomarker driven trial with nivolumab and ipilimumab or VEGFR tyrosine kinase inhibitor (TKI) in naïve metastatic kidney cancer
| Autor: | Fouzia Azzouz, Audrey Simonaggio, Marco Moreira, Cheng-Ming Sun, Nicolas Epaillard, Elena Braychenko, Yann-Alexandre Vano, Stéphane Oudard, Reza Elaidi, Constance Thibault |
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| Rok vydání: | 2020 |
| Předmět: |
0301 basic medicine
Oncology Cancer Research medicine.medical_specialty Indazoles medicine.drug_class Ipilimumab Tyrosine-kinase inhibitor Pazopanib 03 medical and health sciences Antineoplastic Agents Immunological Clinical Trials Phase II as Topic 0302 clinical medicine Internal medicine Antineoplastic Combined Chemotherapy Protocols Biomarkers Tumor Sunitinib Humans Medicine Radiology Nuclear Medicine and imaging Neoplasm Metastasis Protein Kinase Inhibitors Randomized Controlled Trials as Topic Sulfonamides business.industry VEGFR tyrosine kinase inhibitor Metastatic kidney cancer Hematology General Medicine Kidney Neoplasms Nivolumab Pyrimidines Receptors Vascular Endothelial Growth Factor 030104 developmental biology 030220 oncology & carcinogenesis Biomarker (medicine) Drug Therapy Combination business medicine.drug |
| Zdroj: | Bulletin du Cancer. 107:eS22-eS27 |
| ISSN: | 0007-4551 |
| DOI: | 10.1016/s0007-4551(20)30283-6 |
| Popis: | Summary 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. 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. 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. |
| Databáze: | OpenAIRE |
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