Non-interventional, prospective study to evaluate the predictive potential of early CRP kinetics, in particular the CRP flare-response phenomenon, on the efficacy of immunotherapy in advanced urooncological tumors (renal cell carcinoma, urothelial carcinoma). "Prospective Evaluation of the CRP-FLAre phenomenon on Immunotherapy REsponse in Urooncology (FLAIRE)."

Non-interventional, prospective study to evaluate the predictive potential of early CRP kinetics, in particular the CRP flare-response phenomenon, on the efficacy of immunotherapy in advanced urooncological tumors (renal cell carcinoma, urothelial carcinoma). "Prospective Evaluation of the CRP-FLAre phenomenon on Immunotherapy REsponse in Urooncology (FLAIRE)." - FLAIRE

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00031957

Enrollment

200

Registered

2023-06-01

Start date

2023-09-11

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

C64 C65 C66 C67 C68

Interventions

Group 1: The study is aimed at patients with histologically confirmed metastatic renal cell carcinoma or urothelial carcinoma who are receiving immune checkpoint inhibitor therapy (not adjuvant or mai

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Patients with histologically confirmed metastatic renal cell carcinoma or urothelial carcinoma who qualify for immune checkpoint inhibitor therapy (not adjuvant or maintenance therapy) as part of approved standard therapy • Informed written consent to participate in the FLAIRE study has been obtained

Exclusion criteria

Exclusion criteria: Patient is unable to understand the scope, significance, and consequences of this clinical trial

Design outcomes

Primary

Measure	Time frame
Comparison of progression-free survival (PFS) (progression or death), overall survival (OS), and treatment response according to RECIST 1.1, iRECIST, and target lesion change under immunotherapy in CRP kinetics groups per subgroup (mRCC/mUC) - each assessed by the investigator.	—

Secondary

Measure	Time frame
Comparison of PFS and OS after subgroup analysis of the study cohort based on: • CRP concentration before therapy • Programmed Death-Ligand 1 (PD-L1) expression in tumor tissue (Combined Positive Score (CPS), positive immune cells (IC), Tumor Proportion Score (TPS)). • Modified Glasgow Prognostic Score (mGPS) • Incidence of immune-related adverse events (irAEs) according to CTCAE V5.0 until discontinuation of immunotherapy or study termination for the individual study participant. • The objective image morphologic response (ORR) according to RECIST, iRECIST and target lesion change. • Occurrence of (S)AEs	—

Measure

Time frame

Comparison of PFS and OS after subgroup analysis of the study cohort based on: • CRP concentration before therapy • Programmed Death-Ligand 1 (PD-L1) expression in tumor tissue (Combined Positive Score (CPS), positive immune cells (IC), Tumor Proportion Score (TPS)). • Modified Glasgow Prognostic Score (mGPS) • Incidence of immune-related adverse events (irAEs) according to CTCAE V5.0 until discontinuation of immunotherapy or study termination for the individual study participant. • The objective image morphologic response (ORR) according to RECIST, iRECIST and target lesion change. • Occurrence of (S)AEs

—

Countries

Germany

Contacts

Public ContactNiklas Klümper

Klinik und Poliklinik fu¨r Urologie und Kinderurologie Universitätsklinikum Bonn

niklas.kluemper@ukbonn.de+49 228 287 14184

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 27, 2026