A BIOmarker Driven Trial With Nivolumab and Ipilimumab or VEGFR tKi in Naïve Metastatic Kidney Cancer

Summary

Disease and Stage: naïve metastatic kidney cancer. A multicenter, randomized, a Phase 2 BIOmarker driven trial with Nivolumab and Ipilimumab or VEGFR tKi in naïve metastatic Kidney cancer

Timeline

Start

2017-05-31

Primary completion

2021-02-15

Completion

2021-02-15

Publications

• Davidson G, Helleux A, Vano YA, Lindner V, Fattori A, Cerciat M, Elaidi RT, Verkarre V, Sun CM, Chevreau C, Bennamoun M, Lang H, Tricard T, Fridman WH, Sautes-Fridman C, Su X, Plassard D, Keime C, Thibault-Carpentier C, Barthelemy P, Oudard SM, Davidson I, Malouf GG. Mesenchymal-like Tumor Cells and Myofibroblastic Cancer-Associated Fibroblasts Are Associated with Progression and Immunotherapy Response of Clear Cell Renal Cell Carcinoma. Cancer Res. 2023 Sep 1;83(17):2952-2969. doi: 10.1158/0008-5472.CAN-22-3034.
• Vano YA, Elaidi R, Bennamoun M, Chevreau C, Borchiellini D, Pannier D, Maillet D, Gross-Goupil M, Tournigand C, Laguerre B, Barthelemy P, Coquan E, Gravis G, Houede N, Cancel M, Huillard O, Beuzeboc P, Fournier L, Mejean A, Cathelineau X, Doumerc N, Paparel P, Bernhard JC, de la Taille A, Bensalah K, Tricard T, Waeckel T, Pignot G, Braychenko E, Caruso S, Sun CM, Verkarre V, Lacroix G, Moreira M, Meylan M, Bougouin A, Phan L, Thibault-Carpentier C, Zucman-Rossi J, Fridman WH, Sautes-Fridman C, Oudard S. Nivolumab, nivolumab-ipilimumab, and VEGFR-tyrosine kinase inhibitors as first-line treatment for metastatic clear-cell renal cell carcinoma (BIONIKK): a biomarker-driven, open-label, non-comparative, randomised, phase 2 trial. Lancet Oncol. 2022 May;23(5):612-624. doi: 10.1016/S1470-2045(22)00128-0. Epub 2022 Apr 4.
• Epaillard N, Simonaggio A, Elaidi R, Azzouz F, Braychenko E, Thibault C, Sun CM, Moreira M, Oudard S, Vano YA. BIONIKK: A phase 2 biomarker driven trial with nivolumab and ipilimumab or VEGFR tyrosine kinase inhibitor (TKI) in naive metastatic kidney cancer. Bull Cancer. 2020 Jun;107(5S):eS22-eS27. doi: 10.1016/S0007-4551(20)30283-6.

Drugs

Indications