Sequence Strategy of Immuneoncology (IO-IO) vs IO-tyrosine kinase inhibitors (TKI) followed by TKI in metastatic renal cell carcinoma (mRCC): A randomized phase 3 study Meet uro and FICOG trial. COMBO-Seq trial.

Condition studied

Metastatic renal cell carcinoma

Investigational medicinal product(s)

Eligibility

Primary endpoint

The co-primary endpoints are: PFS-2 (PFS-2 is defined as time from randomization to the first documented disease progression or death due to any cause, whichever occurs first, during the second line treatment with TKI); OS (OS is defined as time from randomization to death to any cause).

Endpoint detail

Participants experiencing adverse events (AEs) and participants discontinuing study drug due to AEs according to CTCAE v.5.0., change in the measurement of questionnaires., Longitudinal measurement of plasma and tissue biomarkers in patients treated in the 2 arms., Longitudinal measurement of PBMC in patients treated in the 2 arms., mRNA in EV and PBMC in patients treated in the 2 arms.