2023-505615-21-00招募中3 期
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)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 445
- 试验地点
- 65
- 主要终点
- Event-Free Survival (EFS)
研究概览
简要总结
- To compare event-free survival (EFS) in Arm A (perioperative EV + pembrolizumab and RC + PLND) versus Arm B (neoadjuvant gemcitabine + cisplatin and RC + PLND).
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Event-Free Survival (EFS)
Event-Free Survival (EFS)
次要结局
- Pathologic Complete Response (pCR) Rate
- Overall Survival (OS)
- Disease Free Survival (DFS)
- Pathologic Downstaging (pDS) Rate
- Number of Participants Who Experienced An Adverse Event (AE) (Arm A only)
- Number of Participants Who Discontinued Study Treatment Due to An AE (Arm A only)
- Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ- C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score
- Change from Baseline in EORTC QLQ-C30 Physical Functioning Scale
- Change from Baseline in Urinary, Bowel and Sexual Domains per Bladder Cancer Index (BCI)
- Change from Baseline in EuroQoL-5 Dimensions, 5-level Questionnaire (EQ- 5D-5L) Visual Analogue Score (VAS)
- Time to Deterioration (TTD) in the EORTC-QLQ-C30 Global Health Status/Quality of Life (Items 29 and 30)
- TTD in the Physical Functioning Scale per EORTC QLQ-C30
- TTD in the Role Functioning Scale per EORTC QLQ-C30
- TTD in the Urinary, Bowel and Sexual Domains per BCI
- TTD in the EQ-5D-5L VAS
研究者
Aljosja Rogiers
Scientific
Merck Sharp & Dohme LLC
研究点 (65)
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