CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 87 enrolled
Drug / intervention
Cobimetinib +2 moredrug
Likely dose
Cobimetinib 60 mgfrom 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/NCT03264066
NCT03264066Phase 2Completed
CompareCT.gov

A Phase II, Open-Label, Multicenter, Multicohort Study to Investigate the Efficacy and Safety of Cobimetinib Plus Atezolizumab in Patients With Solid Tumors

Hoffmann-La Roche·interventional·Posted Aug 28, 2017·Updated May 11, 2021

In Brief

A Phase 2 clinical trial evaluating Cobimetinib, Atezolizumab, and 1 other intervention for Solid Tumors. Completed, enrolled 87 participants across 19 sites in 6 countries.

Detailed Summary

This is a study to evaluate the efficacy, safety, and pharmacokinetics of cobimetinib plus atezolizumab in participants with advanced solid tumors including the following cohorts: squamous cell carcinoma of the head and neck (SCCHN), urothelial carcinoma (UC), and renal cell carcinoma (RCC).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumors
CountriesBelgium, Germany, Hungary, South Korea, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedAug 28, 2017
Enrollment StartNov 23, 2017
Primary CompletionJun 25, 2020
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 8.8 years ago

Interventions

Cobimetinibdrug

Participants will receive cobimetinib 60 mg (3 tablets of 20 mg each) orally once a day on Days 1-21 of each 28-day cycle.

Atezolizumabdrug

Atezolizumab will be given at a fixed dose of 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.

Atezolizumab Cohort 7drug

Only for participants in cohort 7, the first dose of atezolizumab of 840 mg will be given by IV infusion on Day 15 of Cycle 1; thereafter, they will receive atezolizumab 840 mg IV infusion Q2W on Days 1 and 15 of Cycle 2 and all subsequent cycles.