Phase 3 Trial of Perioperative EV and Pembro vs. Chemo in Cis-E MIBC
- Conditions
- Muscle Invasive Bladder CancerMedDRA version: 21.1Level: LLTClassification code: 10022877Term: Invasive bladder cancer Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-505615-21-00
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 860
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
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 ongoing sensory or motor neuropathy Grade 2 or higher, Has active keratitis (superficial punctate keratitis) or corneal ulcerations, Has a history of uncontrolled diabetes defined as hemoglobin A1c (HbA1c) =8% or HbA1c 7% to <8% with associated diabetes symptoms, 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method