Klinische Studie

A Phase 3, Randomized, Open-label Study to Evaluate Perioperative Enfortumab Vedotin Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Gemcitabine and Cisplatin in Cisplatin-eligible Participants with Muscle-invasive Bladder Cancer (KEYNOTE-B15 / EV-304)(KEYNOTE-B15)A Phase 3, Randomized, Open-label Study to Evaluate Perioperative Enfortumab Vedotin Plus Pembrolizumab Versus Neoadjuvant Gemcitabine and Cisplatin in Cisplatin-eligible Participants with MIBC
Krankheitsentität(en) Harnblase, Harnleiter, Niere
StudientypInterventionsstudiePhase III
Wesentliche Einschlusskriterien1. Has a histologically confirmed diagnosis of MIBC cT2-T4aN0M0 or cT1-T4aN1M0 with predominant (≥ 50%) urothelial histology (pathologic stage pT2-T4a tumors or pT1 [only if N1] to be confirmed by BICR. 2. Has clinically non-metastatic bladder cancer (N≤1, M0) determined by imaging (CT or MRI of the chest/abdomen/pelvis), confirmed by BICR. 3.Is deemed eligible for RC + PLND by a urologist and/or oncologist and agrees to undergo curative intent standard RC + PLND (including prostatectomy if applicable) as per AUA/ASTRO/ASCO/SUO guidelines 4. Has a TUR of a bladder tumor (obtained within 60 days (+14) days prior to enrollment [ICF signed]) that is submitted and adequate to determine urothelial histology for pathologic stage pT2-T4a or pT1 (only if N1 confirmed by BICR), and PD-L1 status by central pathology vendor. (In the event the sample is not evaluable for PD-L1, the participant will be assigned to the CPS <10 group for stratification). 5. Has an ECOG performance status of 0 or 1.
Wesentliche Ausschlusskriterien1. Has a known additional non-urothelial malignancy that is progressing or has required active anticancer treatment ≤3 years prior to study randomization. 2. Has received any prior systemic anti-neoplastic treatment for MIBC. 3. Has ≥ N2 disease or metastatic disease (M1) as identified by imaging. 4. Is cisplatin-ineligible, as defined by meeting any one of the following criteria: • Impaired renal function with measured or calculated creatinine clearance (CrCl) <60 mL/min (calculated by Cockcroft-Gault method or 24-hour urine collection • ECOG Performance Status ≥ 2 • CTCAE v 5.0 Grade ≥2 audiometric hearing loss (threshold shift of >25 dB averaged at 2 consecutive test frequencies in at least 1 ear; testing is not required at screening; it may be performed at investigator’s discretion) • New York Heart Association (NYHA) Class III or greater heart failure (https://manual.jointcommission.org/releases/TJC2016A/DataElem0439.html) 5. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
Statusrekrutierend
Ansprechpartner & KontaktCaritas-Krankenhaus St. Josef RegensburgUrologieStudienzentrale0941 7823506uro-studienzentrum(at)csj.de