Urothelial Carcinoma
Conditions
Keywords
Urothelial Carcinoma, Avelumab, JAVEMACS, Locally advanced UC, Metastatic UC
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.
Interventions
DRUGAvelumab
This is an observational study, participants who received avelumab as first line maintenance therapy after a PBCT.
Sponsors
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Baseline clinical and demographic characteristics | Baseline | To describe the baseline clinical and demographic characteristics of participants. |
| Characteristics of the first line PBCT just prior to avelumab maintenance | Up to 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | Up to 3 months |
| Progression-Free Survival (PFS) | Up to 3 months |
| Time to Treatment Failure (TTF) | Up to 3 months |
| Time to Next Treatment (TTNT) | Up to 3 months |
| Objective Response Rate (ORR) | Up to 3 months |
Countries
Japan
Contacts
STUDY_DIRECTORMedical Responsible
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Outcome results
None listed