NCT03312530

A Study of Cobimetinib Administered as Single Agent and in Combination With Venetoclax, With or Without Atezolizumab, in Participants With Relapsed and Refractory Multiple Myeloma

A Phase Ib/II Study of Cobimetinib Administered as Single Agent and in Combination With Venetoclax, With or Without Atezolizumab, in Patients With Relapsed and Refractory Multiple Myeloma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This open-label, randomized, multicenter, triple-arm Phase Ib/II study is designed to assess the efficacy, safety, tolerability, and pharmacokinetics of cobimetinib administered as a single agent (Arm A), cobimetinib plus venetoclax (Arm B), and cobimetinib plus venetoclax plus atezolizumab (Arm C) in participants with relapsed and refractory multiple myeloma. Two successive cohorts will evaluate the safety of cobimetinib plus venetoclax and that of cobimetinib plus venetoclax plus atezolizumab in the selected population during the safety run-in phase of the study. Once the dose levels have demonstrated acceptable safety during this phase, randomization will begin for all treatment arms (Arms A, B, and C).

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Cobimetinib	Cobimetinib will be administered as per the schedule specified in the respective arm.
DRUG	Venetoclax	Venetoclax will be administered as per the schedule specified in the respective arm.
DRUG	Atezolizumab	Atezolizumab will be administered as per the schedule specified in the respective arm.

Timeline

• Start date: 2017-11-13
• Primary completion: 2021-05-18
• Completion: 2021-05-18
• First posted: 2017-10-17
• Last updated: 2023-02-28
• Results posted: 2023-02-28

Locations

26 sites across 9 countries: Czechia, Denmark, France, Germany, Netherlands, Norway, Poland, Spain, Sweden