Trial Outcomes & Findings for 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 NCT02788279)

Last Updated: 2019-12-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

363 participants

Primary outcome timeframe

From randomization up to death due to any cause (up to approximately 20 months)

Results posted on

2019-12-11

Participant Flow

A total of 490 participants were screened of whom only 363 participants were randomized.

Participant milestones

Participant milestones
Measure	Regorafenib Participants received regorafenib 160 milligrams (mg) orally once daily 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.	Cobimetinib + Atezolizumab Participants received cobimetinib 60 mg orally on Days 1 to 21 plus atezolizumab 840 mg IV on Day 1 and Day 15 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.	Atezolizumab Participants received atezolizumab monotherapy 1200 mg intravenous (IV) on Day 1 in a 21-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.
Overall Study STARTED	90	183	90
Overall Study Received Treatment (Safety Population)	80	179	90
Overall Study Modified ITT Population	57	125	61
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	90	183	90

Reasons for withdrawal

Reasons for withdrawal
Measure	Regorafenib Participants received regorafenib 160 milligrams (mg) orally once daily 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.	Cobimetinib + Atezolizumab Participants received cobimetinib 60 mg orally on Days 1 to 21 plus atezolizumab 840 mg IV on Day 1 and Day 15 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.	Atezolizumab Participants received atezolizumab monotherapy 1200 mg intravenous (IV) on Day 1 in a 21-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.
Overall Study Death	62	136	72
Overall Study Withdrawal by Subject	10	15	5
Overall Study Lost to Follow-up	0	3	2
Overall Study Sponsor decision	18	29	11

Baseline Characteristics

A Study to Investigate Efficacy and Safety of Cobimetinib Plus Atezolizumab and Atezolizumab Monotherapy Versus Regorafenib in Participants With Metastatic Colorectal Adenocarcinoma (COTEZO IMblaze370)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Regorafenib n=90 Participants Participants received regorafenib 160 milligrams (mg) orally once daily 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.	Cobimetinib + Atezolizumab n=183 Participants Participants received cobimetinib 60 mg orally on Days 1 to 21 plus atezolizumab 840 mg IV on Day 1 and Day 15 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.	Atezolizumab n=90 Participants Participants received atezolizumab monotherapy 1200 mg intravenous (IV) on Day 1 in a 21-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.	Total n=363 Participants Total of all reporting groups
Age, Continuous	58.4 Years STANDARD_DEVIATION 10.3 • n=5 Participants	58.0 Years STANDARD_DEVIATION 11.9 • n=7 Participants	56.7 Years STANDARD_DEVIATION 10.2 • n=5 Participants	57.8 Years STANDARD_DEVIATION 11.1 • n=4 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	75 Participants n=7 Participants	31 Participants n=5 Participants	145 Participants n=4 Participants
Sex: Female, Male Male	51 Participants n=5 Participants	108 Participants n=7 Participants	59 Participants n=5 Participants	218 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	11 Participants n=7 Participants	5 Participants n=5 Participants	25 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	77 Participants n=5 Participants	166 Participants n=7 Participants	82 Participants n=5 Participants	325 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	13 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	12 Participants n=5 Participants	18 Participants n=7 Participants	11 Participants n=5 Participants	41 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	8 Participants n=7 Participants	2 Participants n=5 Participants	10 Participants n=4 Participants
Race (NIH/OMB) White	71 Participants n=5 Participants	152 Participants n=7 Participants	73 Participants n=5 Participants	296 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	14 Participants n=4 Participants

PRIMARY outcome

Timeframe: From randomization up to death due to any cause (up to approximately 20 months)

Population: Analysis was performed on the ITT population.

Outcome measures

Outcome measures
Measure	Regorafenib n=90 Participants Participants received regorafenib 160 milligrams (mg) orally once daily 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.	Cobimetinib + Atezolizumab n=183 Participants Participants received cobimetinib 60 mg orally on Days 1 to 21 plus atezolizumab 840 mg IV on Day 1 and Day 15 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.	Atezolizumab n=90 Participants Participants received atezolizumab monotherapy 1200 mg intravenous (IV) on Day 1 in a 21-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.
Overall Survival (OS)	8.51 months Interval 6.41 to 10.71	8.87 months Interval 7.0 to 10.61	7.10 months Interval 6.05 to 10.05

SECONDARY outcome

Timeframe: From randomization up to disease progression or death due to any cause (up to approximately 20 months)

Population: Analysis was performed on the ITT population.

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.

Outcome measures

Outcome measures
Measure	Regorafenib n=90 Participants Participants received regorafenib 160 milligrams (mg) orally once daily 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.	Cobimetinib + Atezolizumab n=183 Participants Participants received cobimetinib 60 mg orally on Days 1 to 21 plus atezolizumab 840 mg IV on Day 1 and Day 15 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.	Atezolizumab n=90 Participants Participants received atezolizumab monotherapy 1200 mg intravenous (IV) on Day 1 in a 21-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.
Progression-Free Survival (PFS) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)	2.00 months Interval 1.87 to 3.61	1.91 months Interval 1.87 to 1.97	1.94 months Interval 1.91 to 2.1

SECONDARY outcome

Timeframe: From randomization up to death due to any cause (up to approximately 20 months)

Population: Analysis was performed on evaluable participants in the ITT population with measurable disease at baseline, as determined by the investigator.

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.

Outcome measures

Outcome measures
Measure	Regorafenib n=90 Participants Participants received regorafenib 160 milligrams (mg) orally once daily 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.	Cobimetinib + Atezolizumab n=183 Participants Participants received cobimetinib 60 mg orally on Days 1 to 21 plus atezolizumab 840 mg IV on Day 1 and Day 15 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.	Atezolizumab n=90 Participants Participants received atezolizumab monotherapy 1200 mg intravenous (IV) on Day 1 in a 21-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.
Percentage of Participants With Investigator-Assessed Objective Response of Complete Response (CR) or Partial Response (PR) According to RECIST Version 1.1	2.2 percentage of participants Interval 0.27 to 7.8	2.7 percentage of participants Interval 0.89 to 6.26	2.2 percentage of participants Interval 0.27 to 7.8

SECONDARY outcome

Timeframe: From first occurrence of CR or PR up to disease progression or death due to any cause (up to approximately 20 months)

Population: DOR was assessed in participants who had an objective response during the study.

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.

Outcome measures

Outcome measures
Measure	Regorafenib n=2 Participants Participants received regorafenib 160 milligrams (mg) orally once daily 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.	Cobimetinib + Atezolizumab n=5 Participants Participants received cobimetinib 60 mg orally on Days 1 to 21 plus atezolizumab 840 mg IV on Day 1 and Day 15 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.	Atezolizumab n=2 Participants Participants received atezolizumab monotherapy 1200 mg intravenous (IV) on Day 1 in a 21-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.
Duration of Response (DOR) According to RECIST Version 1.1	4.50 months Interval 3.61 to 5.39	1.97 months Interval 1.77 to 3.81	2.81 months Interval 1.84 to 3.78

SECONDARY outcome

Timeframe: Baseline, end of the study (up to approximately 2.5 years)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Regorafenib n=57 Participants Participants received regorafenib 160 milligrams (mg) orally once daily 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.	Cobimetinib + Atezolizumab n=125 Participants Participants received cobimetinib 60 mg orally on Days 1 to 21 plus atezolizumab 840 mg IV on Day 1 and Day 15 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.	Atezolizumab n=61 Participants Participants received atezolizumab monotherapy 1200 mg intravenous (IV) on Day 1 in a 21-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.
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 Long Term Follow Up Month 6	-14.07 units of a scale Standard Deviation 17.14	-10.00 units of a scale Standard Deviation 14.14	-8.00 units of a scale Standard Deviation 15.92
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 Week 44	1.67 units of a scale Standard Deviation 3.33	3.33 units of a scale Standard Deviation 16.07	—
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 Week 45	—	—	4.44 units of a scale Standard Deviation 15.40
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 Week 48	-13.33 units of a scale Standard Deviation 6.67	1.82 units of a scale Standard Deviation 9.47	0.00 units of a scale Standard Deviation 18.86
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 Week 51	—	—	0.00 units of a scale Standard Deviation 18.86
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 Week 52	-5.00 units of a scale Standard Deviation 6.38	3.64 units of a scale Standard Deviation 10.05	—
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 Week 54	—	—	0.00 units of a scale Standard Deviation 18.86
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 Week 56	-2.22 units of a scale Standard Deviation 3.85	5.00 units of a scale Standard Deviation 13.69	—
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 Week 57	—	—	0.00 units of a scale Standard Deviation 18.86
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 Week 60	-3.33 units of a scale Standard Deviation 4.71	2.96 units of a scale Standard Deviation 11.60	0.00 units of a scale Standard Deviation 18.86
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 Week 64	-6.67 units of a scale Standard Deviation 18.86	-2.67 units of a scale Standard Deviation 10.11	—
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 Week 68	—	0.00 units of a scale Standard Deviation 0.00	—
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 Treatment Discontinuation	-17.00 units of a scale Standard Deviation 19.21	-16.24 units of a scale Standard Deviation 23.49	-11.79 units of a scale Standard Deviation 19.01
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 Long Term Follow Up Month 3	-22.29 units of a scale Standard Deviation 24.29	-15.11 units of a scale Standard Deviation 16.80	-20.00 units of a scale Standard Deviation 26.67
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 Long Term Follow Up Month 30	—	-20.00 units of a scale Standard Deviation NA The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so SD is not available.	13.33 units of a scale Standard Deviation NA The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so SD is not available.
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 Long Term Follow Up Month 33	—	-20.00 units of a scale Standard Deviation NA The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so SD is not available.	13.33 units of a scale Standard Deviation NA The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so SD is not available.
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 Long Term Follow Up Month 36	—	-20.00 units of a scale Standard Deviation NA The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so SD is not available.	13.33 units of a scale Standard Deviation NA The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so SD is not available.
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 Week 3	—	—	-1.50 units of a scale Standard Deviation 10.56
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 Week 4	-6.52 units of a scale Standard Deviation 13.90	-3.92 units of a scale Standard Deviation 11.05	—
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 Week 6	—	—	-0.14 units of a scale Standard Deviation 12.49
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 Week 8	-8.97 units of a scale Standard Deviation 13.95	-3.23 units of a scale Standard Deviation 16.15	—
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 Week 9	—	—	-6.67 units of a scale Standard Deviation 17.19
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 Week 12	-7.78 units of a scale Standard Deviation 13.57	-5.10 units of a scale Standard Deviation 15.54	-6.40 units of a scale Standard Deviation 16.61
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 Week 15	—	—	-7.08 units of a scale Standard Deviation 14.90
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 Week 16	-9.12 units of a scale Standard Deviation 17.10	-5.11 units of a scale Standard Deviation 16.67	—
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 Week 18	—	—	-3.70 units of a scale Standard Deviation 14.95
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 Week 20	-7.92 units of a scale Standard Deviation 19.51	-0.87 units of a scale Standard Deviation 14.95	—
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 Week 21	—	—	-8.33 units of a scale Standard Deviation 17.37
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 Week 24	-5.45 units of a scale Standard Deviation 9.81	-3.00 units of a scale Standard Deviation 18.67	0.00 units of a scale Standard Deviation 16.87
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 Week 27	—	—	0.95 units of a scale Standard Deviation 15.60
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 Week 28	-5.00 units of a scale Standard Deviation 9.92	-3.16 units of a scale Standard Deviation 15.29	—
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 Week 30	—	—	-8.00 units of a scale Standard Deviation 20.76
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 Week 32	-4.67 units of a scale Standard Deviation 11.35	-10.74 units of a scale Standard Deviation 21.10	—
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 Week 33	—	—	-1.67 units of a scale Standard Deviation 13.74
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 Week 36	-12.22 units of a scale Standard Deviation 14.25	-1.78 units of a scale Standard Deviation 16.23	4.44 units of a scale Standard Deviation 15.40
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 Week 39	—	—	2.22 units of a scale Standard Deviation 19.25
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 Week 40	-5.00 units of a scale Standard Deviation 11.39	-0.61 units of a scale Standard Deviation 16.18	—
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 Week 42	—	—	4.44 units of a scale Standard Deviation 15.40

SECONDARY outcome

Timeframe: Baseline, end of the study (up to approximately 2.5 years)

Outcome measures

Outcome measures
Measure	Regorafenib n=57 Participants Participants received regorafenib 160 milligrams (mg) orally once daily 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.	Cobimetinib + Atezolizumab n=125 Participants Participants received cobimetinib 60 mg orally on Days 1 to 21 plus atezolizumab 840 mg IV on Day 1 and Day 15 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.	Atezolizumab n=61 Participants Participants received atezolizumab monotherapy 1200 mg intravenous (IV) on Day 1 in a 21-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.
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 Week 3	—	—	-1.70 units of a scale Standard Deviation 17.76
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 Week 4	-6.44 units of a scale Standard Deviation 18.84	-7.00 units of a scale Standard Deviation 21.24	—
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 Week 6	—	—	-4.86 units of a scale Standard Deviation 17.43
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 Week 8	-8.05 units of a scale Standard Deviation 15.98	-4.38 units of a scale Standard Deviation 22.58	—
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 Week 9	—	—	-4.84 units of a scale Standard Deviation 15.78
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 Week 12	-1.04 units of a scale Standard Deviation 18.60	-4.25 units of a scale Standard Deviation 18.51	-3.67 units of a scale Standard Deviation 15.42
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 Week 15	—	—	-4.69 units of a scale Standard Deviation 12.16
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 Week 16	-4.39 units of a scale Standard Deviation 18.08	-1.94 units of a scale Standard Deviation 23.64	—
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 Week 18	—	—	7.41 units of a scale Standard Deviation 18.37
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 Week 20	0.52 units of a scale Standard Deviation 18.38	4.71 units of a scale Standard Deviation 23.28	—
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 Week 21	—	—	6.25 units of a scale Standard Deviation 19.29
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 Week 24	-3.79 units of a scale Standard Deviation 20.19	3.75 units of a scale Standard Deviation 23.95	-6.94 units of a scale Standard Deviation 19.31
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 Week 27	—	—	-2.38 units of a scale Standard Deviation 19.07
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 Week 28	-8.33 units of a scale Standard Deviation 17.25	0.00 units of a scale Standard Deviation 31.18	—
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 Week 30	—	—	5.00 units of a scale Standard Deviation 15.14
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 Week 32	-5.00 units of a scale Standard Deviation 14.80	1.39 units of a scale Standard Deviation 23.79	—
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 Week 33	—	—	6.25 units of a scale Standard Deviation 17.18
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 Week 36	0.00 units of a scale Standard Deviation 7.45	5.56 units of a scale Standard Deviation 16.86	16.67 units of a scale Standard Deviation 25.00
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 Week 39	—	—	22.22 units of a scale Standard Deviation 17.35
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 Week 40	2.08 units of a scale Standard Deviation 10.49	11.36 units of a scale Standard Deviation 12.51	—
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 Week 42	—	—	25.00 units of a scale Standard Deviation 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 Study Week 44	0.00 units of a scale Standard Deviation 13.61	9.52 units of a scale Standard Deviation 15.63	—
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 Week 45	—	—	19.44 units of a scale Standard Deviation 9.62
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 Week 48	-2.78 units of a scale Standard Deviation 4.81	10.61 units of a scale Standard Deviation 15.85	8.33 units of a scale Standard Deviation 0.00
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 Week 51	—	—	8.33 units of a scale Standard Deviation 0.00
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 Week 52	4.17 units of a scale Standard Deviation 15.96	12.12 units of a scale Standard Deviation 17.62	—
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 Week 54	—	—	12.50 units of a scale Standard Deviation 5.89
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 Week 56	-5.56 units of a scale Standard Deviation 9.62	18.75 units of a scale Standard Deviation 9.71	—
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 Week 57	—	—	8.33 units of a scale Standard Deviation 0.00
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 Week 60	-4.17 units of a scale Standard Deviation 17.68	16.67 units of a scale Standard Deviation 15.59	8.33 units of a scale Standard Deviation 0.00
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 Week 64	-4.17 units of a scale Standard Deviation 5.89	6.67 units of a scale Standard Deviation 24.58	—
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 Week 68	—	0.00 units of a scale Standard Deviation NA The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so SD is not available.	—
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 Treatment Discontinuation	-19.87 units of a scale Standard Deviation 23.93	-14.27 units of a scale Standard Deviation 25.98	-14.53 units of a scale Standard Deviation 20.48
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 Long Term Follow-up Month 3	-21.30 units of a scale Standard Deviation 28.60	-6.11 units of a scale Standard Deviation 22.15	-11.36 units of a scale Standard Deviation 20.16
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 Long Term Follow-up Month 6	-13.89 units of a scale Standard Deviation 19.09	-15.83 units of a scale Standard Deviation 15.44	-11.67 units of a scale Standard Deviation 15.14
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 Long Term Follow-up Month 30	—	0.00 units of a scale Standard Deviation NA The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so SD is not available.	8.33 units of a scale Standard Deviation NA The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so SD is not available.
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 Long Term Follow-up Month 33	—	0.00 units of a scale Standard Deviation NA The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so SD is not available.	8.33 units of a scale Standard Deviation NA The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so SD is not available.
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 Long Term Follow-up Month 36	—	0.00 units of a scale Standard Deviation NA The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so SD is not available.	8.33 units of a scale Standard Deviation NA The standard deviation is a measure of the amount of variation or dispersion of a set of values. Number analyzed is 1 so SD is not available.

SECONDARY outcome

Timeframe: Baseline, end of the study (up to approximately 2.5 years)

Population: Analysis was performed on the SAF population.

Outcome measures

Outcome measures
Measure	Regorafenib n=80 Participants Participants received regorafenib 160 milligrams (mg) orally once daily 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.	Cobimetinib + Atezolizumab n=179 Participants Participants received cobimetinib 60 mg orally on Days 1 to 21 plus atezolizumab 840 mg IV on Day 1 and Day 15 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.	Atezolizumab n=90 Participants Participants received atezolizumab monotherapy 1200 mg intravenous (IV) on Day 1 in a 21-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.
Percentage of Participants With Adverse Events (AEs) Serious AEs	23.8 percentage of participants	39.7 percentage of participants	16.7 percentage of participants
Percentage of Participants With Adverse Events (AEs) Non-serious AEs	97.5 percentage of participants	97.8 percentage of participants	93.3 percentage of participants

SECONDARY outcome

Timeframe: 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).

Population: 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

Outcome measures

Outcome measures
Measure	Regorafenib n=124 Participants Participants received regorafenib 160 milligrams (mg) orally once daily 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.	Cobimetinib + Atezolizumab Participants received cobimetinib 60 mg orally on Days 1 to 21 plus atezolizumab 840 mg IV on Day 1 and Day 15 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.	Atezolizumab Participants received atezolizumab monotherapy 1200 mg intravenous (IV) on Day 1 in a 21-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.
Plasma Concentration of Cobimetinib Cycle 1 Day 15 - Predose	195 Nanogram/milliliter (ng/mL) Geometric Coefficient of Variation 190.0	—	—
Plasma Concentration of Cobimetinib Cycle 1 Day 15 - Postdose	362 Nanogram/milliliter (ng/mL) Geometric Coefficient of Variation 89.4	—	—
Plasma Concentration of Cobimetinib Cycle 4 Day 15 - Predose	94.3 Nanogram/milliliter (ng/mL) Geometric Coefficient of Variation 741.9	—	—
Plasma Concentration of Cobimetinib Cycle 4 Day 15 - Postdose	210 Nanogram/milliliter (ng/mL) Geometric Coefficient of Variation 273.4	—	—

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Regorafenib n=89 Participants Participants received regorafenib 160 milligrams (mg) orally once daily 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.	Cobimetinib + Atezolizumab n=179 Participants Participants received cobimetinib 60 mg orally on Days 1 to 21 plus atezolizumab 840 mg IV on Day 1 and Day 15 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.	Atezolizumab Participants received atezolizumab monotherapy 1200 mg intravenous (IV) on Day 1 in a 21-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.
Serum Concentration of Atezolizumab Cycle 1 Day 1 - Predose	NA microgram/milliliter (ug/mL) Geometric Coefficient of Variation NA If more than one-third values were less than reportable, then only the median and maximum are reported and other summary statistics are displayed as non-reportable.	NA microgram/milliliter (ug/mL) Geometric Coefficient of Variation NA If more than one-third values were less than reportable, then only the median and maximum are reported and other summary statistics are displayed as non-reportable.	—
Serum Concentration of Atezolizumab Cycle 1 Day 1 - 30 min post dose	348 microgram/milliliter (ug/mL) Geometric Coefficient of Variation 150.0	259 microgram/milliliter (ug/mL) Geometric Coefficient of Variation 141.0	—
Serum Concentration of Atezolizumab Cycle 2 Day 1 - Predose	81.5 microgram/milliliter (ug/mL) Geometric Coefficient of Variation 35.7	68.2 microgram/milliliter (ug/mL) Geometric Coefficient of Variation 191.2	—
Serum Concentration of Atezolizumab Cycle 2 Day 1 - 30 min post dose	56.2 microgram/milliliter (ug/mL) Geometric Coefficient of Variation NA The amount of variation is not available as the number analyzed is 1.	—	—
Serum Concentration of Atezolizumab Cycle 3 Day 1 - Predose	118 microgram/milliliter (ug/mL) Geometric Coefficient of Variation 45.4	133 microgram/milliliter (ug/mL) Geometric Coefficient of Variation 51.2	—
Serum Concentration of Atezolizumab Cycle 4 Day 1 - Predose	146 microgram/milliliter (ug/mL) Geometric Coefficient of Variation 52.4	167 microgram/milliliter (ug/mL) Geometric Coefficient of Variation 48.4	—
Serum Concentration of Atezolizumab Cycle 4 Day 1 - 30 min post dose	487 microgram/milliliter (ug/mL) Geometric Coefficient of Variation 41.5	415 microgram/milliliter (ug/mL) Geometric Coefficient of Variation 37.2	—
Serum Concentration of Atezolizumab Cycle 5 Day 1 - Predose	155 microgram/milliliter (ug/mL) Geometric Coefficient of Variation NA The amount of variation is not available as the number analyzed is 1.	—	—
Serum Concentration of Atezolizumab Cycle 5 Day 1 - 30 min post dose	456 microgram/milliliter (ug/mL) Geometric Coefficient of Variation NA The amount of variation is not available as the number analyzed is 1.	—	—
Serum Concentration of Atezolizumab Cycle 8 Day 1 - Predose	138 microgram/milliliter (ug/mL) Geometric Coefficient of Variation 54.6	198 microgram/milliliter (ug/mL) Geometric Coefficient of Variation 52.6	—
Serum Concentration of Atezolizumab Cycle 16 Day 1 - Predose	226 microgram/milliliter (ug/mL) Geometric Coefficient of Variation 24.4	264 microgram/milliliter (ug/mL) Geometric Coefficient of Variation NA The amount of variation is not available as the number analyzed is 1.	—
Serum Concentration of Atezolizumab Treatment Discontinuation	97.9 microgram/milliliter (ug/mL) Geometric Coefficient of Variation 114.5	76.6 microgram/milliliter (ug/mL) Geometric Coefficient of Variation 184.9	—
Serum Concentration of Atezolizumab Unscheduled	0.784 microgram/milliliter (ug/mL) Geometric Coefficient of Variation 2159.5	0.539 microgram/milliliter (ug/mL) Geometric Coefficient of Variation NA If more than one-third values were less than reportable, then only the median and maximum are reported and other summary statistics are displayed as non-reportable.	—

SECONDARY outcome

Timeframe: 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)

Population: Analysis was performed on the SAF population and included participants with at least one predose and one postdose ATA assessment.

Outcome measures

Outcome measures
Measure	Regorafenib n=160 Participants Participants received regorafenib 160 milligrams (mg) orally once daily 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.	Cobimetinib + Atezolizumab n=80 Participants Participants received cobimetinib 60 mg orally on Days 1 to 21 plus atezolizumab 840 mg IV on Day 1 and Day 15 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.	Atezolizumab Participants received atezolizumab monotherapy 1200 mg intravenous (IV) on Day 1 in a 21-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.
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab	43.8 percentage of participants	41.3 percentage of participants	—

Adverse Events

Regorafenib

Serious events: 19 serious events

Other events: 78 other events

Deaths: 62 deaths

Cobimetinib + Atezolizumab

Serious events: 71 serious events

Other events: 173 other events

Deaths: 136 deaths

Atezolizumab

Serious events: 15 serious events

Other events: 81 other events

Deaths: 72 deaths

Serious adverse events

Other adverse events

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER