CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 49 enrolled
Drug / intervention
Cobimetinib +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03312530
NCT03312530Phase 2Completed

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

Hoffmann-La Roche·interventional·Posted Oct 17, 2017·Updated Feb 28, 2023

In Brief

A Phase 2 clinical trial evaluating Cobimetinib, Venetoclax, and 1 other intervention for Multiple Myeloma. Completed, enrolled 49 participants across 26 sites in 9 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCzechia, Denmark, France, Germany, Netherlands, Norway, Poland, Spain, Sweden
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedOct 17, 2017
Enrollment StartNov 13, 2017
Primary CompletionMay 18, 2021
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 8.7 years ago

Interventions

Cobimetinibdrug

Cobimetinib will be administered as per the schedule specified in the respective arm.

Venetoclaxdrug

Venetoclax will be administered as per the schedule specified in the respective arm.

Atezolizumabdrug

Atezolizumab will be administered as per the schedule specified in the respective arm.