A Multicenter, Retrospective, Observational Study of Avelumab Maintenance and Subsequent Therapies in Japanese Patients With Locally Advanced or Metastatic Urothelial Carcinoma
Overview
- Phase
- Not Applicable
- Intervention
- Avelumab
- Conditions
- Urothelial Carcinoma
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- Enrollment
- 360
- Locations
- 51
- Primary Endpoint
- Characteristics of the first line PBCT just prior to avelumab maintenance
- Status
- Active, not recruiting
- Last Updated
- 2 months ago
Overview
Brief Summary
This study is a multicenter, non-interventional, retrospective, medical chart review of locally advanced or metastatic (la/m) Urothelial Cancer UC participants who were prescribed avelumab as first line maintenance therapy after a platinum-based chemotherapy. This study aims to understand the index date (i.e., at the initiation of avelumab maintenance therapy) demographics and clinical characteristics of participants with locally advanced/metastatic Urothelial Carcinoma in Japan, and to describe their treatment patterns and outcomes.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants diagnosed with locally advanced/metastatic urothelial carcinoma (la/m UC) before receiving avelumab first line maintenance therapy
- •Participants with la/m UC (irrespective of tumor histology) whose disease has not progressed (ongoing stable disease, partial response, or complete response) following completion of first line PBCT and who has been treated with avelumab
- •Participants who has been started avelumab first line maintenance therapy for la/m UC from 24 Feb 2021 (date of approval for UC) to 6 months before the date of approval of implementation of this study at each site
- •Participants aged \>= 18 years old at index date
- •Other protocol defined inclusion criteria could apply
Exclusion Criteria
- •Participant participated in a clinical trial in la/m UC during the study periods.
Arms & Interventions
Urothelial Carcinoma Cohort
This is a single cohort study enrolling Participants with Urothelial Carcinoma (UC), who are prescribed treatment with avelumab as first line maintenance therapy after a platinum-based chemotherapy (PBCT).
Intervention: Avelumab
Outcomes
Primary Outcomes
Characteristics of the first line PBCT just prior to avelumab maintenance
Time Frame: Up to 3 months
Baseline clinical and demographic characteristics
Time Frame: Baseline
To describe the baseline clinical and demographic characteristics of participants.
Secondary Outcomes
- Objective Response Rate (ORR)(Up to 3 months)
- Progression-Free Survival (PFS)(Up to 3 months)
- Time to Treatment Failure (TTF)(Up to 3 months)
- Overall Survival (OS)(Up to 3 months)
- Time to Next Treatment (TTNT)(Up to 3 months)