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SOGUG-AVELUMAB_RWD

NCT05700344 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 125

Last updated 2024-02-29

No results posted yet for this study

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).

Conditions

  • Metastatic Urothelial Carcinoma

Interventions

DRUG

Avelumab

Single Group Assignment

Sponsors & Collaborators

  • Adknoma Health Research

    collaborator INDUSTRY

  • Spanish Oncology Genito-Urinary Group

    lead OTHER

Principal Investigators

  • Áurea Molina · Complejo Hospitalario Universitario A Coruña (CHUAC)

  • Ovidio Fernández · Complejo Hospitalario Universitario Ourense (CHOU)

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-05
Primary Completion
2023-07-31
Completion
2023-11-02

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05700344 on ClinicalTrials.gov