A Study to Investigate Efficacy and Safety of Cobimetinib Plus Atezolizumab and Atezolizumab Monotherapy Versus Regorafenib in Participants With Metastatic Colorectal Adenocarcinoma (COTEZO IMblaze370)
CompletedPhase 3Results postedLast updated 11 December 2019
What this trial tests
Phase 3 trial testing Atezolizumab (MPDL3280A), an Engineered Anti-PDL1 Antibody in Colorectal Cancer in 363 participants. Completed in 26 December 2018.
18 and older, any sex, with Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Survival (OS)Primary· From randomization up to death due to any cause (up to approximately 20 months)
Overall survival is defined as the time (in months) between the date of randomization and the date of death due to any cause. Participants who were not reported as having died at the date of analysis were censored at the date when they were last known to be alive. Participants who did not have post-baseline information were censored at the date of randomization + 1 day. Median OS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.
Group
Value
95% CI
Regorafenib
8.51
6.41 – 10.71
Cobimetinib + Atezolizumab
8.87
7.00 – 10.61
Atezolizumab
7.10
6.05 – 10.05
Progression-Free Survival (PFS) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)Secondary· From randomization up to disease progression or death due to any cause (up to approximately 20 months)
PFS was defined as the time from randomization to disease progression as determined by the investigator with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearan
Group
Value
95% CI
Regorafenib
2.00
1.87 – 3.61
Cobimetinib + Atezolizumab
1.91
1.87 – 1.97
Atezolizumab
1.94
1.91 – 2.10
Percentage of Participants With Investigator-Assessed Objective Response of Complete Response (CR) or Partial Response (PR) According to RECIST Version 1.1Secondary· From randomization up to death due to any cause (up to approximately 20 months)
PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions). Objective response and its 95% CI were calculated using the Clopper-Pearson method.
Group
Value
95% CI
Regorafenib
2.2
0.27 – 7.80
Cobimetinib + Atezolizumab
2.7
0.89 – 6.26
Atezolizumab
2.2
0.27 – 7.80
Duration of Response (DOR) According to RECIST Version 1.1Secondary· From first occurrence of CR or PR up to disease progression or death due to any cause (up to approximately 20 months)
DOR is defined as the period measured from the date of the first occurrence of a CR or PR (whichever status is recorded first) until the first date that progressive disease or death is documented. Disease progression was determined on the basis of investigator assessment with use of RECIST v1.1. Median DOR was estimated using the Kaplan-Meier method, and the 95% CI was calculated using the method of Brookmeyer and Crowley.
Group
Value
95% CI
Regorafenib
4.50
3.61 – 5.39
Cobimetinib + Atezolizumab
1.97
1.77 – 3.81
Atezolizumab
2.81
1.84 – 3.78
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life-C30 Questionnaire (EORTC QLQ-C30) Physical Functioning Sub-scale ScoreSecondary· Baseline, end of the study (up to approximately 2.5 years)
The EORTC QLQ-C30 questionnaire consisted of 30 questions generating five functional scores (physical, role, cognitive, emotional, and social); a global health status/global quality of life scale score; three symptom scale scores (fatigue, pain, and nausea and vomiting); and six stand alone one-item scores that capture additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and perceived financial burden. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functionin
Week 3
Group
Value
95% CI
Atezolizumab
-1.50
± 10.56
Week 4
Group
Value
95% CI
Regorafenib
-6.52
± 13.90
Cobimetinib + Atezolizumab
-3.92
± 11.05
Week 6
Group
Value
95% CI
Atezolizumab
-0.14
± 12.49
Week 8
Group
Value
95% CI
Regorafenib
-8.97
± 13.95
Cobimetinib + Atezolizumab
-3.23
± 16.15
Week 9
Group
Value
95% CI
Atezolizumab
-6.67
± 17.19
Week 12
Group
Value
95% CI
Regorafenib
-7.78
± 13.57
Cobimetinib + Atezolizumab
-5.10
± 15.54
Atezolizumab
-6.40
± 16.61
Week 15
Group
Value
95% CI
Atezolizumab
-7.08
± 14.90
Week 16
Group
Value
95% CI
Regorafenib
-9.12
± 17.10
Cobimetinib + Atezolizumab
-5.11
± 16.67
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life-C30 Questionnaire (EORTC QLQ-C30) Global Quality of Life Sub-scale Score at the End of the StudySecondary· Baseline, end of the study (up to approximately 2.5 years)
The EORTC QLQ-C30 questionnaire consisted of 30 questions generating five functional scores (physical, role, cognitive, emotional, and social); a global health status/global quality of life scale score; three symptom scale scores (fatigue, pain, and nausea and vomiting); and six stand alone one-item scores that capture additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and perceived financial burden. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functionin
Week 3
Group
Value
95% CI
Atezolizumab
-1.70
± 17.76
Week 4
Group
Value
95% CI
Regorafenib
-6.44
± 18.84
Cobimetinib + Atezolizumab
-7.00
± 21.24
Week 6
Group
Value
95% CI
Atezolizumab
-4.86
± 17.43
Week 8
Group
Value
95% CI
Regorafenib
-8.05
± 15.98
Cobimetinib + Atezolizumab
-4.38
± 22.58
Week 9
Group
Value
95% CI
Atezolizumab
-4.84
± 15.78
Week 12
Group
Value
95% CI
Regorafenib
-1.04
± 18.60
Cobimetinib + Atezolizumab
-4.25
± 18.51
Atezolizumab
-3.67
± 15.42
Week 15
Group
Value
95% CI
Atezolizumab
-4.69
± 12.16
Week 16
Group
Value
95% CI
Regorafenib
-4.39
± 18.08
Cobimetinib + Atezolizumab
-1.94
± 23.64
Percentage of Participants With Adverse Events (AEs)Secondary· Baseline, end of the study (up to approximately 2.5 years)
Serious AEs
Group
Value
95% CI
Regorafenib
23.8
Cobimetinib + Atezolizumab
39.7
Atezolizumab
16.7
Non-serious AEs
Group
Value
95% CI
Regorafenib
97.5
Cobimetinib + Atezolizumab
97.8
Atezolizumab
93.3
Plasma Concentration of CobimetinibSecondary· Predose (0 hours) and 3 to 6 hours after dose on Day 15 of Cycles 1 and 4 (1 cycle = 28 days) (up to approximately 2.5 years).
Cycle 1 Day 15 - Predose
Group
Value
95% CI
Cobimetinib + Atezolizumab
195
± 190.0
Cycle 1 Day 15 - Postdose
Group
Value
95% CI
Cobimetinib + Atezolizumab
362
± 89.4
Cycle 4 Day 15 - Predose
Group
Value
95% CI
Cobimetinib + Atezolizumab
94.3
± 741.9
Cycle 4 Day 15 - Postdose
Group
Value
95% CI
Cobimetinib + Atezolizumab
210
± 273.4
Serum Concentration of AtezolizumabSecondary· Pre-infusion (0 hours) on Day 1 of Cycle 1 up to approximately 2.5 years. Detailed time frame is explained in the outcome measure description field.
Pre-infusion (0 hours) on Day 1 of Cycles 1 to 4; 30 minutes post-infusion on Day 1 of Cycles 1 and 4; pre-infusion (0 hours) on Day 1 of Cycle 8 and every 8 cycles thereafter; at treatment discontinuation; 120 days after treatment discontinuation (up to approximately 2.5 years) (1 cycle = 28 days)
Cycle 1 Day 1 - Predose
Group
Value
95% CI
Atezolizumab
NA
± NA
Cobimetinib + Atezolizumab
NA
± NA
Cycle 1 Day 1 - 30 min post dose
Group
Value
95% CI
Atezolizumab
348
± 150.0
Cobimetinib + Atezolizumab
259
± 141.0
Cycle 2 Day 1 - Predose
Group
Value
95% CI
Atezolizumab
81.5
± 35.7
Cobimetinib + Atezolizumab
68.2
± 191.2
Cycle 2 Day 1 - 30 min post dose
Group
Value
95% CI
Atezolizumab
56.2
± NA
Cycle 3 Day 1 - Predose
Group
Value
95% CI
Atezolizumab
118
± 45.4
Cobimetinib + Atezolizumab
133
± 51.2
Cycle 4 Day 1 - Predose
Group
Value
95% CI
Atezolizumab
146
± 52.4
Cobimetinib + Atezolizumab
167
± 48.4
Cycle 4 Day 1 - 30 min post dose
Group
Value
95% CI
Atezolizumab
487
± 41.5
Cobimetinib + Atezolizumab
415
± 37.2
Cycle 5 Day 1 - Predose
Group
Value
95% CI
Atezolizumab
155
± NA
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to AtezolizumabSecondary· Pre-infusion (0 hours) on Day 1 of Cycles 1 to 4, 8, and every 8 cycles thereafter; at treatment discontinuation; 120 days after treatment discontinuation (up to approximately 2.5 years) (1 cycle = 28 days)
Group
Value
95% CI
Cobimetinib + Atezolizumab
43.8
Atezolizumab
41.3
Adverse events — posted to ClinicalTrials.gov
Time frame: From baseline to end of study (approximately 2.5 years)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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· recruiting
NCT07432633 — [18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications
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· recruiting
NCT07523919 — Functional and Respiratory Determinants of Long-Term Colorectal Cancer Outcomes
· recruiting
NCT07529301 — Functional and Respiratory Predictors of Early Postoperative Outcomes
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
Last refreshed: 11 December 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02788279.