on-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).

Recruiting

• Conditions: C64; C65; C66; C67; C68; Malignant neoplasm of kidney, except renal pelvis; Malignant neoplasm of renal pelvis; Malignant neoplasm of ureter; Malignant neoplasm of bladder; Malignant neoplasm of other and unspecified urinary organs

• Registration Number: DRKS00031957
• Lead Sponsor: Klinik und Poliklinik fu¨r Urologie und Kinderurologie Universitätsklinikum Bonn

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

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

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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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