Klinische Studie

A Phase 3, Open-Label, Multi-Center, Randomized Study Evaluating the Efficacy of TAR-200 in Combination with Cetrelimab Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants with BCG Naïve High-Risk Non-Muscle Invasive Bladder Cancer (HR-NMIBC)(SunRISe-3)Efficacy of intravesical drug delivery system + systemic PD-1 inhibitor vs intravesical Bacillus Calmette-Guerin in participants with BCG-naive high-risk non- muscle invasive bladder cancer
NCT-
DRKS-
Krankheitsentität(en) Harnblase, Harnleiter, Niere
StudientypInterventionsstudiePhase III
Wesentliche Einschlusskriterien1. BCG-naïve (participants who have not received prior intravesical BCG or who previously received but stopped BCG more than 3 years before study entry are eligible). 2. Histologically confirmed diagnosis of high-risk, non-muscle invasive urothelial carcinoma, defined as high-grade papillary Ta or T1, or CIS, in participants who are BCG naive. Mixed histology tumours are allowed if urothelial differentiation (transitional cell histology) is predominant (e.g., <20% variant histologic subtype). However, the presence of neuroendocrine, micropapillary, signet ring cell, plasmacytoid, or sarcomatoid features will make a participant ineligible. 3. Visible papillary disease must be fully resected (absent) prior to dosing and documented on baseline cystoscopy. 4. Eastern Cooperative Oncology Group performance status Grade 0, 1, or 2. 5. Adequate organ function as determined by screening lab.
Wesentliche Ausschlusskriterien1. Histologically confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (i.e., ≥T2). 2. Concurrent extra-vesical (i.e., urethra, ureter, or renal pelvis) non-muscle invasive transitional cell carcinoma of the urothelium. 3. Bladder post-void residual volume > 350-mL after second void at screening. 4. Presence of any bladder or urethral anatomic feature that, in the opinion of the Investigator, may prevent the safe insertion, indwelling use, or removal of aintravesical drug-device system. 5. Prior therapy with PD-1, PD-L1 or PD-L2 inhibitors, or with an agent directed to another co-inhibitory T-cell receptor.
Statusrekrutierend
Ansprechpartner & KontaktCaritas-Krankenhaus St. Josef RegensburgUrologieStudienzentrale0941 7823506uro-studienzentrum(at)csj.de