CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 125 enrolled
Drug / intervention
Avelumabdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05700344
NCT05700344N/ACompleted

Multicentric, Observational Study to Evaluate Real World Data of Avelumab in First Line Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma, a SOGUG Study

Spanish Oncology Genito-Urinary Group·observational·Posted Jan 26, 2023·Updated Feb 29, 2024

In Brief

An observational study evaluating Avelumab for Metastatic Urothelial Carcinoma. Completed, enrolled 125 participants across 22 sites.

Detailed Summary

The study goal is to evaluate the effectiveness in clinical practice of Avelumab as first line maintenance therapy in patients with locally advanced or metastatic Urothelial Carcinoma, who have not progressed after first line platinum-based treatment. Study is performed at national hospitals from approximately 22 different sites and expecting to recruit 120 patients. Patients understanding the nature of the study by providing their informed consent prior to participation. * Patients of both sexes diagnosed with locally advanced or metastatic Urothelial Carcinoma, stage IV disease before first line with carboplatin/cisplatin-based chemotherapy. No disease progression after four-six cycles of ChT according to the Response Evaluation Criteria in Solid Tumor with a treatment free interval of 4-10 weeks before Avelumab initiation date. * Patients who started Avelumab as maintenance therapy in first line after 21/Jan./2021 and before 27/Apr./2022 (both dates included).

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesSpain

Timeline

N/ACompletedFinished
2023202420252026
First PostedJan 26, 2023
Enrollment StartSep 5, 2022
Primary CompletionJul 31, 2023
Study CompletionNov 2, 2023
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 3.4 years ago

Interventions

Avelumabdrug

Single Group Assignment