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.

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-523903-31-00

Enrollment

500

Registered

2026-09-03

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic renal cell carcinoma

Brief summary

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).

Detailed description

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.

Interventions

DRUGAXITINIB

DRUGNIVOLUMAB

DRUGCABOZANTINIB

DRUGPEMBROLIZUMAB

DRUGSORAFENIB

DRUGSUNITINIB

DRUGIPILIMUMAB

DRUGLENVATINIB MESILATE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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).	—

Secondary

Measure	Time frame
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.	—

Outcome results

None listed

Source: EU CTIS · Data processed: Sep 5, 2026