A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection
Summary
This Phase III, open-label, randomized, multicenter study is to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with observation in participants with muscle-invasive UC who are at high risk for recurrence following resection. Eligible participants were randomized by a 1:1 ratio into atezolizumab group or control group.
Timeline
- Start
- 2015-10-05
- Primary completion
- 2019-11-30
- Completion
- 2022-06-14
Outcome
Missed primary endpoint
Stopped: “Sponsor decided to terminate the study early because the study did not meet its primary endpoint and because the study had met its goals of providing safety and additional exploratory efficacy information for atezolizumab monotherapy in MIBC.”
registry Observation vs Atezolizumab; p = 0.2446; Hazard Ratio (HR) 0.892 (95% CI 0.735 to 1.081); Log Rank NCT02450331 ↗
paper The trial did not meet its primary endpoint of improved disease-free survival in the atezolizumab group over observation. PMID 33721560 ↗
Publications
- Landon BV, Huang J, Evangelopoulou EG, Anagnostou V, Canzoniero JV. Liquid biopsy approaches to capture minimal residual disease and therapy response in patients with early stage cancers. Int Rev Cell Mol Biol. 2026;399:113-143. doi: 10.1016/bs.ircmb.2024.12.002. Epub 2024 Dec 14.
- Elias R, Aragaki AK, Hoffman-Censits JH, Hahn NM, McConkey DJ, Johnson BA 3rd. Intratumoral Expression of a Composite B Cell / CD8 T Cell Biomarker Stratifies Overall Survival by Circulating Tumor DNA Status and Benefit From Adjuvant Immunotherapy in High-Risk Muscle-Invasive Urothelial Carcinoma. J Urol. 2026 Mar;215(3):294-304. doi: 10.1097/JU.0000000000004828. Epub 2025 Oct 27.
- Powles T, Young A, Nimeiri H, Madison RW, Fine A, Zollinger DR, Huang Y, Xu C, Gjoerup OV, Aushev VN, Wu HT, Aleshin A, Carter C, Davarpanah N, Degaonkar V, Gupta P, Mariathasan S, Schleifman E, Assaf ZJ, Oxnard G, Hegde PS. Molecular residual disease detection in resected, muscle-invasive urothelial cancer with a tissue-based comprehensive genomic profiling-informed personalized monitoring assay. Front Oncol. 2023 Jul 31;13:1221718. doi: 10.3389/fonc.2023.1221718. eCollection 2023.
- Powles T, Assaf ZJ, Degaonkar V, Grivas P, Hussain M, Oudard S, Gschwend JE, Albers P, Castellano D, Nishiyama H, Daneshmand S, Sharma S, Sethi H, Aleshin A, Shi Y, Davarpanah N, Carter C, Bellmunt J, Mariathasan S. Updated Overall Survival by Circulating Tumor DNA Status from the Phase 3 IMvigor010 Trial: Adjuvant Atezolizumab Versus Observation in Muscle-invasive Urothelial Carcinoma. Eur Urol. 2024 Feb;85(2):114-122. doi: 10.1016/j.eururo.2023.06.007. Epub 2023 Jul 26.
- Bellmunt J, Hussain M, Gschwend JE, Albers P, Oudard S, Castellano D, Daneshmand S, Nishiyama H, Majchrowicz M, Degaonkar V, Shi Y, Mariathasan S, Grivas P, Drakaki A, O'Donnell PH, Rosenberg JE, Geynisman DM, Petrylak DP, Hoffman-Censits J, Bedke J, Kalebasty AR, Zakharia Y, van der Heijden MS, Sternberg CN, Davarpanah NN, Powles T; IMvigor010 Study Group. Adjuvant atezolizumab versus observation in muscle-invasive urothelial carcinoma (IMvigor010): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Apr;22(4):525-537. doi: 10.1016/S1470-2045(21)00004-8. Epub 2021 Mar 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atezolizumab | Monoclonal antibody | 1200 mg | Intravenous |