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

NCT03330886 | Completed

• 1 other identifier: ML39853
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urothelial Carcinoma

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants with Adverse Events (AE)

  Up to approximately 2 years.

Secondary Outcomes (4)

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

  Up to approximately 2 years.

• Duration of Response (DOR)

  Up to approximately 2 years.

• Progression Free Survival (PFS)

  Up to approximately 2 years.

• Overall Survival (OS)

  Up to approximately 2 years.

Interventions

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).

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with histologically or cytologically documented locally advanced or metastatic urothelial carcinoma (including renal pelvis, ureters, urinary bladder, and urethra) that have received the indication for treatment with atezolizumab as per local label (disease progression during or following platinum containing therapy) in the context of routine clinical practice.

You may qualify if:

• 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.

You may not qualify if:

• Contraindicated atezolizumab therapy

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

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

Buenos Aires, B1610BAL, Argentina

Location

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

atezolizumab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2017
• First Posted: November 6, 2017
• Study Start: February 9, 2018
• Primary Completion: March 2, 2019
• Study Completion: March 2, 2019
• Last Updated: March 13, 2023

Record last verified: 2023-03

Locations

AR (1)