Trial · NCT02788279
A Study to Investigate Efficacy and Safety of Cobimetinib Plus Atezolizumab and Atezolizumab Monotherapy Versus Regorafenib in Participants With Metastatic Colorectal Adenocarcinoma (COTEZO IMblaze370)
NCT02788279, Phase 3, Completed, Hoffmann-La Roche; results first posted 2019-06-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Investigate Efficacy and Safety of Cobimetinib Plus Atezolizumab and Atezolizumab Monotherapy Versus Regorafenib in Participants With Metastatic Colorectal Adenocarcinoma (COTEZO IMblaze370). Trials, record NCT02788279. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02788279
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study to Investigate Efficacy and Safety of Cobimetinib Plus Atezolizumab and Atezolizumab Monotherapy Versus Regorafenib in Participants With Metastatic Colorectal Adenocarcinoma (COTEZO IMblaze370)
- NCT number
- NCT02788279
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 363 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Colorectal Cancer
- Interventions
- Atezolizumab (MPDL3280A), an Engineered Anti-PDL1 Antibody, Cobimetinib, Regorafenib
- First posted
- 2016-06-02
- Last updated
- 2019-12-11
- Other registries' IDs
- eudract:2016-000202-11
- Results first posted
- 2019-06-18
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | 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. |
| Secondary | Progression-Free Survival (PFS) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | 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 appearance of one or more new lesions was also considered progression. 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. |
| Secondary | Percentage of Participants With Investigator-Assessed Objective Response of Complete Response (CR) or Partial Response (PR) According to RECIST Version 1.1 | 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. |
| Secondary | Duration of Response (DOR) According to RECIST Version 1.1 | 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. |
| Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life-C30 Questionnaire (EORTC QLQ-C30) Physical Functioning Sub-scale Score | 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 functioning subscales is indicative of better functioning. |
| Secondary | 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 Study | 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 functioning subscales is indicative of better functioning. |
| Secondary | Percentage of Participants With Adverse Events (AEs) | Baseline, end of the study (up to approximately 2.5 years) | |
| Secondary | Plasma Concentration of Cobimetinib | 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). | |
| Secondary | Serum Concentration of Atezolizumab | 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) |
| Secondary | Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab | 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) |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | From randomization up to death due to any cause (up to approximately 20 months) | Analysis was performed on the ITT population. | months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | From randomization up to disease progression or death due to any cause (up to approximately 20 months) | Analysis was performed on the ITT population. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Investigator-Assessed Objective Response of Complete Response (CR) or Partial Response (PR) According to RECIST Version 1.1 | From randomization up to death due to any cause (up to approximately 20 months) | Analysis was performed on evaluable participants in the ITT population with measurable disease at baseline, as determined by the investigator. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) According to RECIST Version 1.1 | From first occurrence of CR or PR up to disease progression or death due to any cause (up to approximately 20 months) | DOR was assessed in participants who had an objective response during the study. | months | MEDIAN |
| SECONDARY | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life-C30 Questionnaire (EORTC QLQ-C30) Physical Functioning Sub-scale Score | Baseline, end of the study (up to approximately 2.5 years) | Analysis was performed on PRO-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable at specified time point. | units of a scale | MEAN |
| SECONDARY | 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 Study | Baseline, end of the study (up to approximately 2.5 years) | Analysis was performed on PRO-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable at specified time point. | units of a scale | MEAN |
| SECONDARY | Percentage of Participants With Adverse Events (AEs) | Baseline, end of the study (up to approximately 2.5 years) | Analysis was performed on the SAF population. | percentage of participants | NUMBER |
| SECONDARY | Plasma Concentration of Cobimetinib | 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). | The pharmacokinetic (PK) evaluable population included all participants who received any dose of study medication and who had at least one post-baseline PK sample available. Only included participants in the Cobimetnib arm | Nanogram/milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Serum Concentration of Atezolizumab | 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. | The pharmacokinetic (PK) evaluable population included all participants who received any dose of study medication and who had at least one post-baseline PK sample available. Also, only included participants to whom Atezolizumab was administered. | microgram/milliliter (ug/mL) | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab | 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) | Analysis was performed on the SAF population and included participants with at least one predose and one postdose ATA assessment. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group183
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Regorafenib | 8.51 | 95% Confidence Interval 6.41 to 10.71 | months | |
| Overall Survival (OS) | Cobimetinib + Atezolizumab | 8.87 | 95% Confidence Interval 7.00 to 10.61 | months | |
| Overall Survival (OS) | Atezolizumab | 7.10 | 95% Confidence Interval 6.05 to 10.05 | months | |
| Progression-Free Survival (PFS) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | Regorafenib | 2.00 | 95% Confidence Interval 1.87 to 3.61 | months | |
| Progression-Free Survival (PFS) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | Cobimetinib + Atezolizumab | 1.91 | 95% Confidence Interval 1.87 to 1.97 | months | |
| Progression-Free Survival (PFS) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | Atezolizumab | 1.94 | 95% Confidence Interval 1.91 to 2.10 | months | |
| Percentage of Participants With Investigator-Assessed Objective Response of Complete Response (CR) or Partial Response (PR) According to RECIST Version 1.1 | Regorafenib | 2.2 | 95% Confidence Interval 0.27 to 7.80 | percentage of participants | |
| Percentage of Participants With Investigator-Assessed Objective Response of Complete Response (CR) or Partial Response (PR) According to RECIST Version 1.1 | Cobimetinib + Atezolizumab | 2.7 | 95% Confidence Interval 0.89 to 6.26 | percentage of participants | |
| Percentage of Participants With Investigator-Assessed Objective Response of Complete Response (CR) or Partial Response (PR) According to RECIST Version 1.1 | Atezolizumab | 2.2 | 95% Confidence Interval 0.27 to 7.80 | percentage of participants | |
| Duration of Response (DOR) According to RECIST Version 1.1 | Regorafenib | 4.50 | 95% Confidence Interval 3.61 to 5.39 | months |
1 to 10 of 183Source ClinicalTrials.gov
See all 183 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Regorafenib | 90 | |
| Overall Study | STARTED | Cobimetinib + Atezolizumab | 183 | |
| Overall Study | STARTED | Atezolizumab | 90 | |
| Overall Study | Received Treatment (Safety Population) | Regorafenib | 80 | |
| Overall Study | Received Treatment (Safety Population) | Cobimetinib + Atezolizumab | 179 | |
| Overall Study | Received Treatment (Safety Population) | Atezolizumab | 90 | |
| Overall Study | Modified ITT Population | Regorafenib | 57 | |
| Overall Study | Modified ITT Population | Cobimetinib + Atezolizumab | 125 | |
| Overall Study | Modified ITT Population | Atezolizumab | 61 | |
| Overall Study | COMPLETED | Regorafenib | 0 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events438
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ANAEMIA | Blood and lymphatic system disorders | Regorafenib | 8 | 80 | 9 |
| other | ANAEMIA | Blood and lymphatic system disorders | Cobimetinib + Atezolizumab | 25 | 179 | 28 |
| other | ANAEMIA | Blood and lymphatic system disorders | Atezolizumab | 5 | 90 | 5 |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Regorafenib | 2 | 80 | 2 |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Cobimetinib + Atezolizumab | 10 | 179 | 10 |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Atezolizumab | 0 | 90 | 0 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Regorafenib | 21 | 80 | 27 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Cobimetinib + Atezolizumab | 30 | 179 | 34 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Atezolizumab | 13 | 90 | 19 |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | Regorafenib | 2 | 80 | 2 |
1 to 10 of 438Source ClinicalTrials.gov
See all 438 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Regorafenib | 62 | 90 |
| Total, all-cause mortality | Cobimetinib + Atezolizumab | 136 | 183 |
| Total, all-cause mortality | Atezolizumab | 72 | 90 |
| Total, other adverse events | Regorafenib | 78 | 80 |
| Total, other adverse events | Cobimetinib + Atezolizumab | 173 | 179 |
| Total, other adverse events | Atezolizumab | 81 | 90 |
| Total, serious adverse events | Regorafenib | 19 | 90 |
| Total, serious adverse events | Cobimetinib + Atezolizumab | 71 | 183 |
| Total, serious adverse events | Atezolizumab | 15 | 90 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02788279
GET https://conductscience.org/api/trials/v1/NCT02788279/results?page=2