A Phase 3, Randomized, Double-blind Study to Evaluate Perioperative Pembrolizumab (MK-3475) + Neoadjuvant Chemotherapy versus Perioperative Placebo + Neoadjuvant Chemotherapy in Cisplatin-eligible Participants with Muscle-invasive Bladder Cancer (KEYNOTE-866) - MK-3475-866

Merck Sharp & Dohme LLC0 个研究点目标入组 912 人开始时间: 2023年11月16日最近更新: 2024年7月22日

适应症

试验速览

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•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.

•Has a known additional malignancy that is progressing or has required active anti-cancer treatment =3 years of study randomization with certain exceptions., Has had an allogenic tissue/solid organ transplant., 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.

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