At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed adenocarcinoma from colon or rectum, Stage 4 AJCC 7th edition
- ✓Disease progression or intolerance to ≥2 systemic chemotherapy regimens for metastatic CRC including fluoropyrimidines, irinotecan, and oxaliplatin; adjuvant regimen counts as one if recurrence within 6 months; disease progression within 3 months of last therapy
- ✓ECOG performance status 0 or 1
- ✓Life expectancy ≥3 months
- ✕Active or untreated CNS metastases
- ✕Prior therapy with cancer immunotherapy, MEK inhibitor, or regorafenib
- ✕Uncontrolled tumor-related pain (narcotic use must be stable)
- ✕Uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage >once per 28 days
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Open-Label, Multicenter, Three-Arm, Randomized Study to Investigate the Efficacy and Safety of Cobimetinib Plus Atezolizumab and Atezolizumab Monotherapy vs. Regorafenib in Patients With Previously Treated Unresectable Locally Advanced or Metastatic Colorectal Adenocarcinoma
In Brief
A Phase 3 clinical trial evaluating Atezolizumab (MPDL3280A), an Engineered Anti-PDL1 Antibody, Cobimetinib, and 1 other intervention for Colorectal Cancer. Completed, enrolled 363 participants across 73 sites in 11 countries.
Detailed Summary
This is a Phase III, multicenter, open-label, three-arm, randomized study in participants with unresectable locally advanced or metastatic colorectal cancer (CRC) who have received at least two prior regimens of cytotoxic chemotherapy for metastatic disease. The study compares regorafenib, a standard of care therapy in this setting, to cobimetinib plus atezolizumab and atezolizumab monotherapy.
Study Details
Timeline
Interventions
Participants will receive atezolizumab IV at 840 mg on Day 1 and Day 15 in a 28-day cycle as a combination therapy or at 1200 mg on Day 1 in a 21-day cycle as a monotherapy until disease progression according to RECIST Version 1.1, unacceptable toxicity, death, participant's or physician decision to withdraw, or pregnancy, whichever occurs first.
Participants will receive cobimetinib 60 mg orally on Days 1 to 21 in a 28-day cycle as a combination therapy until disease progression according to RECIST Version 1.1, unacceptable toxicity, death, participant's or physician decision to withdraw, or pregnancy, whichever occurs first.
Participants will receive regorafenib 160 mg orally on Days 1 to 21 in a 28-day cycle until disease progression according to RECIST Version 1.1, unacceptable toxicity, death, participant's or physician decision to withdraw, or pregnancy, whichever occurs first.