Regional, Multi-center, Prospective, Single-arm, Real-World Observational study (SPADE)

Not Applicable

Conditions: Health Condition 1: - Health Condition 2: C67- Malignant neoplasm of bladder

Registration Number: CTRI/2023/09/058102

Lead Sponsor: Merck Pte Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Adult patients, aged greater or equal to 18 years of age (or per country’s legal adult age) at the time of signing the informed consent form(ICF)

2. Patients with unresectable local advanced or metastatic UC with measurable stage IV disease regardless of histology 3. Patients who have completed 1L platinum-based chemotherapy with no evidence of disease progression 4. Patients planned to receive avelumab as the 1L maintenance therapy according to country’s approved drug label

5. Patients who have provided written informed consent to participate in this study

Exclusion Criteria

1. Patients with contraindications for avelumab according to the country’s approved drug label

2. Patients who have participated in any interventional clinical trial of a drug or device within the 28 days prior to the start of avelumab maintenance therapy

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Patient demographic and clinical characteristics <br/ ><br>2. Treatment patterns of 1L platinum-based induction chemotherapy and avelumab maintenance therapy <br/ ><br>3. Treatment outcomes: <br/ ><br>• OS rate at 6 months and 12 months (estimated by Kaplan-Meier [KM] approach) after the start of avelumab maintenance therapy <br/ ><br>• HRQoL assessment using paper-based questionnaires administered by the study nurse / coordinator, EQ-5D-5L and NCCN/FACT FBlSI-18 questionnaires, at Baseline and EOS Visits: <br/ ><br>• HRQoL scoresTimepoint: Study visits will be scheduled according to routine clinical practice in terms of visit frequency, assessments and treatment. <br/ ><br> <br/ ><br>ECOG PS at Baseline, 6-month / EOS and 12-month / EOS Visits <br/ ><br> <br/ ><br>OS rate at 6 months and 12 months <br/ ><br>

Secondary Outcome Measures