drugset / Trial / NCT02876224

Study of Cobimetinib in Combination With Atezolizumab and Bevacizumab in Participants With Gastrointestinal and Other Tumors

NCT02876224

Phase 1 Completed 51 enrolled Hoffmann-La Roche
Non-randomizedSequentialOpen-labelTreatment

Summary

This is an open-label, multicenter, single-arm, two-stage, Phase Ib study designed to assess the safety, tolerability, and pharmacokinetics of oral cobimetinib with intravenous (IV) atezolizumab and bevacizumab in participants with metastatic colorectal cancer (mCRC) who have received and progressed on at least one prior line of therapy that contained a fluoropyrimidine and oxaliplatin or irinotecan. There are two stages in this study: Stage 1 (safety run-in phase) and Stage 2 (dose expansion phase with two cohorts, an expansion cohort and a biopsy cohort).

Timeline

Start
2016-09-30
Primary completion
2019-06-25
Completion
2019-06-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Atezolizumab Monoclonal antibody 840 mg Intravenous
Subject Bevacizumab Monoclonal antibody 5 mg/kg Intravenous
Subject Cobimetinib Small molecule 60 mg Oral

Indications