drugset / Trial / NCT02609984

Study to Compare the Safety and Efficacy of CMB305 With Atezolizumab to Atezolizumab Alone in Participants With Sarcoma (IMDZ-C232/V943A-002)

Phase 2 Terminated 89 enrolled Immune Design Genentech, Inc. · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This is an open-label Phase 2 randomized study that will examine the use of the study agents, CMB305 (sequentially administered LV305 which is a dendritic cell-targeting viral vector expressing the New York Esophageal Squamous Cell Carcinoma 1 gene \[NY-ESO-1\] and G305 which is a NY-ESO-1 recombinant protein plus glucopyranosyl lipid adjuvant-stable emulsion \[GLA-SE\]) in combination with atezolizumab or atezolizumab alone, in participants with locally advanced, relapsed or metastatic sarcoma (synovial or myxoid/round cell liposarcoma) expressing the NY-ESO-1 protein. There is no formal primary hypothesis for this study.

Timeline

Start: 2015-04-29
Primary completion: 2019-02-06
Completion: 2019-02-06

Outcome

Missed primary endpoint

Stopped: “This study did not meet the efficacy objective”

registry CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab vs Atezolizumab; p = 0.4900; Hazard Ratio (HR) 0.8568 NCT02609984 ↗

registry CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab vs Atezolizumab; p = 0.4737; Hazard Ratio (HR) 1.2145 NCT02609984 ↗

paper Although the combination of CMB305 and atezolizumab did not result in significant increases in PFS or OS compared with atezolizumab alone PMID 34260265 ↗

Publications

Chawla SP, Van Tine BA, Pollack SM, Ganjoo KN, Elias AD, Riedel RF, Attia S, Choy E, Okuno SH, Agulnik M, von Mehren M, Livingston MB, Keedy VL, Verschraegen CF, Philip T, Bohac GC, Yurasov S, Yakovich A, Lu H, Chen M, Maki RG. Phase II Randomized Study of CMB305 and Atezolizumab Compared With Atezolizumab Alone in Soft-Tissue Sarcomas Expressing NY-ESO-1. J Clin Oncol. 2022 Apr 20;40(12):1291-1300. doi: 10.1200/JCO.20.03452. Epub 2021 Jul 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Atezolizumab	Monoclonal antibody	1200 mg	Intravenous
Subject	G305	Protein / enzyme biologic	5 ug	Intramuscular
Subject	G305	Protein / enzyme biologic	250 ug	Intramuscular
Subject	LV305	Unknown	1e+10 vg	Intrathecal