Perioperative Pembrolizumab (MK-3475) Plus Neoadjuvant Chemotherapy Versus Perioperative Placebo Plus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle-invasive Bladder Cancer (MIBC) (MK-3475-866/KEYNOTE-866)
Фаза 3 – широко изпитване преди одобрение
Заболявания:
Bladder Cancer
Спонсор: Merck Sharp & Dohme LLC
Налично на:
БГ
Обобщение
A global study to evaluate peri-operative pembrolizumab with chemotherapy versus placebo to pembrolizumab plus chemotherapy in cisplatin eligible patients.
Кой може да участва
Inclusion Criteria:
* Have a histologically confirmed diagnosis of urothelial carcinoma (UC) / muscle invasive bladder cancer (MIBC) (T2-T4aN0M0 or T1-T4aN1M0) with predominant (≥50%) urothelial histology.
* Have clinically non-metastatic bladder cancer (N≤1 M0) determined by imaging (computed tomography (CT) or magnetic resonance imaging (MRI)) of the chest/abdomen/pelvis.
* Be deemed eligible for Radical Cystectomy (RC) + Pelvic Lymph Node Dissection (PLND).
* Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Have adequate organ function.
* Male and female participants are eligible to participate if they agree to the contraception use as per study protocol.
Exclusion Criteria:
* Has a known additional malignancy that is progressing or has required active anti-cancer treatment ≤3 years of study randomization with certain exceptions.
* Has received any prior systemic treatment for MIBC or non-invasive muscle bladder cancer (NMIBC - prior treatment for NMIBC with intravesical BCG/chemotherapy is permitted) or prior therapy with an anti- programmed cell death 1 (PD-1), anti-programmed cell death ligand 1/ ligand 2 (PD-L1/L2), or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4).
* Has ≥N2 disease or metastatic disease (M1) as identified by imaging.
* Is cisplatin-ineligible, as defined by meeting any one of the cisplatin ineligibility criteria as per protocol.
* Has received prior systemic anticancer therapy including investigational agents within 3 years of randomization or any radiotherapy to the bladder.
* Has undergone partial cystectomy of the bladder to remove any NMIBC or MIBC.
* Has received a live or live attenuated vaccine within 30 days before the first dose of study intervention.
* Has a diagnosis of immunodeficiency or has a known history of human immunodeficiency virus (HIV) infection, Hepatitis B infection or known active Hepatitis C infection.
* Has a known psychiatric or substance abuse disorder.
* Has had an allogenic tissue/solid organ transplant.
Места на провеждане
21
Австралия (1)
Mid North Coast Cancer Institute ( Site 1256)
Port Macquarie , New South Wales
Белгия (1)
UZ Brussel ( Site 0358)
Brussels , Bruxelles-Capitale, Region de
Канада (1)
Tom Baker Cancer Centre ( Site 0100)
Calgary , Alberta
Дания (1)
Rigshospitalet University Hospital ( Site 0401)
Copenhagen , Capital Region
Франция (1)
CHU de Bordeaux- Hopital Saint Andre ( Site 0456)
Bordeaux , Aquitaine
Унгария (1)
Pecsi Tudomanyegyetem AOK ( Site 1009)
Pécs , Baranya
Ireland (1)
Cork University Hospital ( Site 0722)
Cork
Израел (1)
Ha Emek Medical Center ( Site 0808)
Afula
Италия (1)
Policlinico Gemelli di Roma ( Site 0558)
Roma , Abruzzo
Япония (1)
Hirosaki University Hospital ( Site 1502)
Hirosaki , Aomori
Mexico (1)
Centro de Urologia Avanzada del Noreste S.A. de C.V. ( Site 0254)
Monterrey , Nuevo León
Полша (1)
Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 1068)
Bydgoszcz , Kuyavian-Pomeranian Voivodeship
Russia (1)
Clinic of Bashkortostan State Medical University ( Site 0869)
Ufa , Baskortostan, Respublika
Южна Корея (1)
National Cancer Center ( Site 1354)
Goyang-si , Kyonggi-do
Испания (1)
Hospital San Pedro de Alcantara ( Site 0654)
Cáceres , Extremadura
Швеция (1)
Laenssjukhuset Ryhov ( Site 1205)
Jönköping , Jönköping County
Тайланд (1)
Ramathibodi Hospital. ( Site 1451)
Bangkok , Bangkok
Турция (1)
Hacettepe Universitesi Tıp Fakultesi ( Site 0911)
Ankara
Ukraine (1)
Cherkasy Regional Oncology Dispensary ( Site 0959)