Lead Investigator: Victor Moreno, START Madrid-Fundacion Jimenez Diaz (FJD)
Title of Proposal Research: Retrospective analysis of different doses of atezolizumab in patients with advanced solid tumors
Vivli Data Request: 9434
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Cancer is a group of diseases where abnormal cells grow uncontrollably and can spread to other parts of the body. Advanced solid tumors are cancers that have formed solid masses and have spread beyond their original site. Millions of people worldwide are affected by various types of advanced cancers, making it a major public health concern.
Currently, the standard dose of atezolizumab is 1200 mg given intravenously (through a vein). However, not all patients respond the same way to this dose. Some may benefit just as much from a lower dose, which could reduce side effects and treatment costs. This research aims to find out if lower doses of atezolizumab are as effective and safe as the standard dose. The findings could lead to better, more personalized cancer treatments, improving patient care and outcomes.
This research will use existing data from a previous clinical trial involving 661 patients with advanced solid tumors. This is called a retrospective study because it looks back at data that has already been collected. Researchers will compare the effectiveness and safety of the standard 1200 mg dose with a lower dose of atezolizumab. They will look at key outcomes such as:
• Overall survival (OS): How long patients live after starting treatment.
• Progression-free survival (PFS): How long patients live without their cancer getting worse.
• Adverse events (AEs): Any side effects or other unwanted effects from the treatment.
To ensure the results are reliable, the study will use statistical methods to account for differences between patients and analyze the data. This will include cleaning the data to correct any inaccuracies and using statistical software to perform the analysis.
This study aims to improve our understanding of atezolizumab dosing, potentially leading to more effective and personalized treatments for cancer patients, ultimately enhancing their quality of life and treatment outcomes.
Requested Studies:
A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Atezolizumab (MPDL3280A) Administered Intravenously as a Single Agent to Patients With Locally Advanced or Metastatic Solid Tumors or Hematologic Malignancies
Data Contributor: Roche
Study ID: NCT01375842
Sponsor ID: PCD4989g