Health Condition 1: - Health Condition 2: C67- Malignant neoplasm of bladder
Conditions
Interventions
Intervention1: NA: NA
Sponsors
Merck Pte Ltd
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Patient demographic and clinical characteristics 2. Treatment patterns of 1L platinum-based induction chemotherapy and avelumab maintenance therapy 3. Treatment outcomes: • OS rate at 6 months and 12 months (estimated by Kaplan-Meier [KM] approach) after the start of avelumab maintenance therapy • 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: • HRQoL scoresTimepoint: Study visits will be scheduled according to routine clinical practice in terms of visit frequency, assessments and treatment. ECOG PS at Baseline, 6-month / EOS and 12-month / EOS Visits OS rate at 6 months and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| N/ATimepoint: N/A | — |
Countries
Australia, Hong Kong, India, Malaysia, Republic of Korea, Singapore, Taiwan
Contacts
Public ContactDr Harshveer Malhi
Merck Specialities Pvt. Limited
Outcome results
None listed