Trial Investigates Nivolumab With/Without Ipilimumab and Anti-VEGFR TKI for RCC

Yann-Alexandre Vano, MD, Georges-Pompidou European Hospital, Paris, France, explains the methods and design of the phase 2 BIONIKK trial (NCT02960906).

Investigators on the phase 2 BIONIKK trial enrolled 199 patients with metastatic renal cell carcinoma (RCC). Patients were randomized and administered either nivolumab alone (Opdivo; n = 58), nivolumab and ipilimumab (Yervoy; n = 101), or an or anti-VEGFR tyrosine kinase inhibitor (TKI; n = 40) in the frontline.

Vano presented updated data from the trial at the 2023 Genitourinary Cancers Symposium.

Transcription:

0:08 | The BIONIKK trial is a randomized phase 2 trial performed in France in 16 centers. It is a biomarker-based trial because the patient has to be randomized to a molecular grouping of the tumor tissue. It's first-line metastatic kidney cancer, and patients were randomized according to the molecular group of the tumors. We are developing certified gene signatures, and patients are classified as tumors. Patients are classified between 1 to 4. Patients in groups 1 and 4 were randomized to receive nivolumab or nivolumab/ipilimumab. Patients in groups 2 and 3 were randomized to receive nivolumab/ipilimumab or an anti-VEGFR TKI.

1:00 | Randomization is not balanced because in a prior study, we showed that groups 2 and 3 were sensitive to a VEGFR TKI, but it was the opposite for groups 1 and 4, they were not sensitive to the VEGFR TKI. That's why groups 1 and 4 were randomized between 2 I/O-based therapies groups 2 and 3 were randomized between a double I/O and a VEGFR TKI. This is a non-comparative phase 2 trial and we already published the results last year, but we had a limited follow-up of 18 months. Now, we have presented the updated results with a more prolonged follow up with 46 months follow-up, and results, according to the molecular group, and regarding overall survival and as a second-line treatment, after progression.