13 results
Primary Objectives:- To determine the efficacy of IRE ablation of renal masses, measured by histopathologic examination of the targeted tumour.- To determine the safety of IRE ablation of small renal masses, by evaluating device and procedural…
To assess the PD, PK and safety of the Zoreline 10.8 mg goserelin subcutaneous (SC) implant.
To compare prostate-specific antigen (PSA) progression-free survival (PFS) failure rates during long-term treatment with 3-monthly subcutaneous (s.c.) injections of degarelix or goserelin in prostate cancer patients (PSA PFS failure is defined as…
Primary: 1/ To evaluate the safety and tolerability of ribociclib with letrozole in men and postmenopausal women with HR+, HER2- aBC who received no prior hormonal therapy for advanced disease.Secondary: To assess the clinical efficacy of ribociclib…
Primary Objectives:- To determine the clinical efficacy of IRE ablation of small renal masses (* 4cm), assessed by calculating recurrence and residual disease at follow-up, measured through the (non-)presence of tumour enhancement on cross-sectional…
The primary objective of this study is to evaluate the safety and tolerability of iscalimab at two dose levels (600 mg and 300 mg) in patients withSjögren*s Syndrome, who participated in the TWINSS core study,CCFZ533B2201.Secondary…
Secondary objectiveTo assess the safety and tolerability of the investigational treatments in patients with moderate to severe hidradenitis suppurativa (HS) by:• Number and severity of AEs • Physical examination, vital signs, safety laboratory…
The purpose of this trial is to- determine the dose-response of iscalimab in a population of patients with moderate-to-severe Sjögren*s Syndrome (SjS), defined by ESSDAI >=5and ESSPRI >=5 (Cohort 1)- evaluate the preliminary efficacy…
To assess the proportion of patients who are alive without disease progression at 6 months based on local investigator assessment per RECIST v1.1 in cohort A and cohort B 13-03-2019: new cohort added (3 cohorts now)
The primary objective of the study is to evaluate if treatment with a non-steroidal aromatase inhibitor combined with CDK4/6 inhibition in first line followed at progression by fulvestrant in second line (strategy A) improves progression-free…
The primary objective is to determine in which percentage of patients with prostate cancer with an indication for ADT, it is safe to extend the dosing interval of goserelin 10,8 mg by four weeks, before the 4th injection, using a testosterone based…
Primary Objective(s) (Cohort 1):* To demonstrate that CFZ533 600 mg and/or 300 mg bi-weekly (Q2W), subcutaneous (SC), is non-inferior to a tacrolimus-based regimen with respect to the proportion of patients who experience composite efficacy failure…
This study will allow the assessment of the ability of CFZ533 to replace calcineurin inhibitors (CNIs) in terms of anti-rejection efficacy, while providing potentially better renal function with an expected similar safety and tolerability profile.…