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Completed

NCT Number: NCT03232593

A Study of Atezolizumab (Tecentriq®) in Ministry of Food and Drug Safety (MFDS)-Approved Indication(s)

This Phase 4, prospective, multicenter, non-interventional, regulatory post-marketing surveillance study will collect information on the the safety and effectiveness of atezolizumab under the clinical practice, and update the drug label approved by the MFDS in Korea.

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Key information

Conditions

Urothelial Carcinoma Adenocarcinoma Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Hepatocellular Carcinoma, Non-Small-Cell Lung Carcinoma, Non-small Cell Lung Carcinoma, Transitional Cell Digestive System Diseases Digestive System Neoplasms Hepatocellular Carcinoma Liver Diseases Liver Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Small Cell Lung Carcinoma Thoracic Neoplasms Triple Negative Breast Carcinoma Triple Negative Breast Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Dong-A University Hospital, Busan, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants who are administered with atezolizumab for the locally approved indications

Exclusion criteria

  • Participants with a known hypersensitivity to atezolizumab or to any of the excipients

Treatment and study plan

Atezolizumab

Drug

Participants will receive atezolizumab as per the local label and standard of care at physician's discretion.

Other names: Tecentriq

Primary outcomes

  1. Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)

    Time frame: Approximately 6 years

Secondary outcomes

  1. Percentage of Participants With Complete Response (CR) Assessed per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

    Time frame: Approximately 6 years

  2. Percentage of Participants With Partial Response (PR) Assessed per RECIST 1.1

    Time frame: Approximately 6 years

  3. Percentage of Participants With Stable Disease (SD) Assessed per RECIST 1.1

    Time frame: Approximately 6 years

  4. Percentage of Participants With Progressive Disease (PD) Assessed per RECIST 1.1

    Time frame: Approximately 6 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Post-Marketing Surveillance of Tecentriq in MFDS-Approved Indication(s)

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jul 28, 2017
Registry last updated
Aug 24, 2022

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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