A Study of Atezolizumab in Advanced Solid Tumors

Summary

The primary efficacy objective for this study is to evaluate non-progression rate (NPR) at 18 weeks in participants with advanced solid tumors treated with atezolizumab, defined as the percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1, or according to disease-specific criteria for prostate cancer and malignant pleural mesothelioma.

Timeline

Start

2015-07-16

Primary completion

2018-04-04

Completion

2020-07-28

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

paper enrollment was stopped early, including in cohorts that passed stage I boundaries of success. PMID 35305400 ↗

paper recruitment was stopped before these signals could be confirmed in stage II. PMID 35305400 ↗

Publications

• Tabernero J, Andre F, Blay JY, Bustillos A, Fear S, Ganta S, Jaeger D, Maio M, Mileshkin L, Melero I. Phase II multicohort study of atezolizumab monotherapy in multiple advanced solid cancers. ESMO Open. 2022 Apr;7(2):100419. doi: 10.1016/j.esmoop.2022.100419. Epub 2022 Mar 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Atezolizumab	Monoclonal antibody	1200 mg	Intravenous

Indications