Perioperative EV + Pembrolizumab vs Neoadjuvant Chemotherapy for Cisplatin-eligible MIBC
- Conditions
- Muscle Invasive Bladder Cancer
- Registration Number
- JPRN-jRCT2041210011
- Lead Sponsor
- Koh Yasuhiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
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 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
- 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 percent or HbA1c 7 percent to <8 percent with associated diabetes symptoms
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Pathological Complete Response (pCR) Rate<br>- Event-free Survival (EFS)
- Secondary Outcome Measures
Name Time Method - Overall Survival (OS)<br>- Disease-Free Survival (DFS)<br>- Pathological Downstaging Rate (pDSR)<br>- Participants experiencing adverse events (AEs)<br>- Participants discontinuing study drug due to AEs<br>- Participant experiencing perioperative complications<br>- European Organization for Research and Treatment of Cancer QoL questionnaire-Core 30 (EORTC QLQ-C30)<br>- Bladder Cancer Index (BCI)<br>- Quality of Life-5 Dimensions, 5-level Questionnaire (EQ-5D-5L)