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OpenTrials
Completed

NCT Number: NCT03330886

A Study of the Safety of Atezolizumab in Patients With Advanced or Metastatic Urothelial Carcinoma in Argentina

The main purpose is to study the safety and effectiveness of atezolizumab in patients with locally advanced or metastatic urothelial carcinoma whose disease has worsened during or following platinum-containing chemotherapy, or within 12 months of receiving platinum-containing chemotherapy, either before (neoadjuvant) or after (adjuvant) surgical treatment in common clinical practice settings in Argentina.

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Key information

Conditions

Urothelial Carcinoma Carcinoma Carcinoma, Transitional Cell Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Sex eligibility

All sexes

Study type

Observational

Primary location

Productos Roche S.A. Quimica e Industrial, División Farmacéutica

Buenos Aires, B1610BAL, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed an informed consent form submitted to the Administración Nacional de Medicamentos Alimentos y Tecnología Médica (ANMAT)
  • Histologically or cytologically documented locally advanced or metastatic urothelial carcinoma (including renal pelvis, ureters, urinary bladder, and urethra).
  • Have received at least one dose of atezolizumab as per local label and clinical practice.

Exclusion criteria

  • Contraindicated atezolizumab therapy

Treatment and study plan

Atezolizumab

Drug

Atezolizumab will be administered via IV at a 1200-mg dose over 60 minutes every 3 weeks (to be reduced to 30 minutes every 3 weeks if the first dose is tolerated).

Primary outcomes

  1. Percentage of Participants with Adverse Events (AE)

    Time frame: Up to approximately 2 years.

Secondary outcomes

  1. Percentage of participants with Confirmed Objective Response (ORR) of Complete Response (CR) or Partial Response (PR)

    Time frame: Up to approximately 2 years.

  2. Duration of Response (DOR)

    Time frame: Up to approximately 2 years.

  3. Progression Free Survival (PFS)

    Time frame: Up to approximately 2 years.

  4. Overall Survival (OS)

    Time frame: Up to approximately 2 years.

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Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Observational Study of the Safety of Atezolizumab in Patients With Advanced or Metastatic Urothelial Carcinoma in Argentina

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 6, 2017
Registry last updated
Mar 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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