Trial Outcomes & Findings for Atezolizumab With or Without Cobimetinib in Treating Patients With Metastatic Bile Duct Cancer That Cannot Be Removed by Surgery or Gallbladder Cancer (NCT NCT03201458)
NCT ID: NCT03201458
Last Updated: 2024-04-05
Results Overview
PFS within each treatment arm will be summarized descriptively and compared between groups, under the assumption of Cox proportional hazards, using the stratified log-rank test to account for tumor site. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
86 participants
Primary outcome timeframe
From date of randomization to time of progression or death, assessed up to 1 year
Results posted on
2024-04-05
Participant Flow
Participant milestones
| Measure |
Arm A (Atezolizumab)
Patients receive atezolizumab IV over 30-60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Atezolizumab, Cobimetinib)
Patients receive atezolizumab IV over 30-60 minutes on days 1 and 15 and cobimetinib PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
43
|
|
Overall Study
COMPLETED
|
39
|
38
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
Arm A (Atezolizumab)
Patients receive atezolizumab IV over 30-60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Atezolizumab, Cobimetinib)
Patients receive atezolizumab IV over 30-60 minutes on days 1 and 15 and cobimetinib PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
No longer eligible
|
2
|
5
|
|
Overall Study
Health event before starting
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Atezolizumab With or Without Cobimetinib in Treating Patients With Metastatic Bile Duct Cancer That Cannot Be Removed by Surgery or Gallbladder Cancer
Baseline characteristics by cohort
| Measure |
Arm A (Atezolizumab)
n=43 Participants
Patients receive atezolizumab IV over 30-60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Atezolizumab, Cobimetinib)
n=43 Participants
Patients receive atezolizumab IV over 30-60 minutes on days 1 and 15 and cobimetinib PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
60 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Age, Continuous
|
62 years
n=93 Participants
|
63 years
n=4 Participants
|
63 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
53 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
72 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=93 Participants
|
37 Participants
n=4 Participants
|
70 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=93 Participants
|
43 participants
n=4 Participants
|
86 participants
n=27 Participants
|
|
Subgroup
Extrahepatic cholangiocarcinoma (EHC)
|
9 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Subgroup
Gallbladder cancer (GBC)
|
12 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Subgroup
Intrahepatic cholangiocarcinoma (IHC)
|
22 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
46 Participants
n=27 Participants
|
|
Height
|
163.4 centimeter (cm)
n=93 Participants
|
166.4 centimeter (cm)
n=4 Participants
|
164.9 centimeter (cm)
n=27 Participants
|
|
Weight
|
71.5 kilogram (kg)
n=93 Participants
|
78.5 kilogram (kg)
n=4 Participants
|
76.9 kilogram (kg)
n=27 Participants
|
|
Body Surface Area
|
1.81 meters squared (m^2)
n=93 Participants
|
1.90 meters squared (m^2)
n=4 Participants
|
1.89 meters squared (m^2)
n=27 Participants
|
PRIMARY outcome
Timeframe: From date of randomization to time of progression or death, assessed up to 1 yearPFS within each treatment arm will be summarized descriptively and compared between groups, under the assumption of Cox proportional hazards, using the stratified log-rank test to account for tumor site. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Arm A (Atezolizumab)
n=39 Participants
Patients receive atezolizumab IV over 30-60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Atezolizumab, Cobimetinib)
n=38 Participants
Patients receive atezolizumab IV over 30-60 minutes on days 1 and 15 and cobimetinib PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Progression Free Survival (PFS)
Progression free at 1 Year after Randomization
|
0 Participants
|
3 Participants
|
|
Progression Free Survival (PFS)
Progressed or Off Treatment by 1 Year after Randomization
|
39 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: Up to 1 yearWill be assessed using National Cancer Institute's Common Terminology Criteria for Adverse Events version 5.0. The incidence of AEs will be tabulated by subgroups of interest (e.g. grade 3 or higher, organ class, relationship to study drug). For analyses at the individual level, the highest grade and relationship to study drug will be assumed if multiple events have occurred. Toxicity will be tabulated by type and grade and will be summarized with descriptive statistics.
Outcome measures
| Measure |
Arm A (Atezolizumab)
n=39 Participants
Patients receive atezolizumab IV over 30-60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Atezolizumab, Cobimetinib)
n=38 Participants
Patients receive atezolizumab IV over 30-60 minutes on days 1 and 15 and cobimetinib PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Number of Participants With Adverse Events
Grade 3 or higher adverse event considered at least possibly related to the study drug(s)
|
15 Participants
|
17 Participants
|
|
Number of Participants With Adverse Events
No grade 3 or higher adverse events considered at least possibly related to the study drug(s)
|
24 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Evaluable population excluded patients removed from study prior to the first radiographic evaluation time point for clinical progression or death from tumor progression.
Defined as the proportion of response evaluable subjects who have a complete response or partial response and will be assessed by Response Evaluation Criteria in Solid Tumors version 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Arm A (Atezolizumab)
n=36 Participants
Patients receive atezolizumab IV over 30-60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Atezolizumab, Cobimetinib)
n=30 Participants
Patients receive atezolizumab IV over 30-60 minutes on days 1 and 15 and cobimetinib PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Objective Response Rate
Stable Disease
|
10 Participants
|
13 Participants
|
|
Objective Response Rate
Complete Response
|
0 Participants
|
0 Participants
|
|
Objective Response Rate
Partial Response
|
1 Participants
|
1 Participants
|
|
Objective Response Rate
Clinical or Radiographic Progression
|
25 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: From date of randomization to time of death, assessed up to 1 yearResults will be summarized descriptively and compared between groups, under the assumption of proportional hazards, using the stratified log-rank test to account for tumor site.
Outcome measures
| Measure |
Arm A (Atezolizumab)
n=39 Participants
Patients receive atezolizumab IV over 30-60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Atezolizumab, Cobimetinib)
n=38 Participants
Patients receive atezolizumab IV over 30-60 minutes on days 1 and 15 and cobimetinib PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Survival
Alive at 1 year
|
9 Participants
|
9 Participants
|
|
Overall Survival
Deceased or Lost to Follow Up at 1 year
|
30 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: Day 21Population: Participants with paired high-quality biopsies (fold change pre- and post-treatment).
Change between the pre-treatment tumor biopsy to the on-treatment biopsy collected on day 21.
Outcome measures
| Measure |
Arm A (Atezolizumab)
n=8 Participants
Patients receive atezolizumab IV over 30-60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Atezolizumab, Cobimetinib)
n=5 Participants
Patients receive atezolizumab IV over 30-60 minutes on days 1 and 15 and cobimetinib PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Change in CD8+ Density Within the Tumor
|
0.719 cells per millimeter squared
Standard Deviation 0.469
|
0.892 cells per millimeter squared
Standard Deviation 0.535
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 1 yearThe number of participants with tumors expressing PD-L1 by 1 percent or more.
Outcome measures
| Measure |
Arm A (Atezolizumab)
n=9 Participants
Patients receive atezolizumab IV over 30-60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Atezolizumab, Cobimetinib)
n=9 Participants
Patients receive atezolizumab IV over 30-60 minutes on days 1 and 15 and cobimetinib PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Number of Participants With PD-L1 Expression
1% or more Positivity
|
1 Participants
|
1 Participants
|
|
Number of Participants With PD-L1 Expression
No expression
|
8 Participants
|
8 Participants
|
Adverse Events
Arm A (Atezolizumab)
Serious events: 32 serious events
Other events: 38 other events
Deaths: 35 deaths
Arm B (Atezolizumab, Cobimetinib)
Serious events: 31 serious events
Other events: 36 other events
Deaths: 35 deaths
Serious adverse events
| Measure |
Arm A (Atezolizumab)
n=43 participants at risk
Patients receive atezolizumab IV over 30-60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Atezolizumab, Cobimetinib)
n=43 participants at risk
Patients receive atezolizumab IV over 30-60 minutes on days 1 and 15 and cobimetinib PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distention
|
0.00%
0/43 • Up to 1 year
|
4.7%
2/43 • Up to 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
14.0%
6/43 • Up to 1 year
|
9.3%
4/43 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/43 • Up to 1 year
|
2.3%
1/43 • Up to 1 year
|
|
Psychiatric disorders
Altered mental status
|
0.00%
0/43 • Up to 1 year
|
2.3%
1/43 • Up to 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/43 • Up to 1 year
|
2.3%
1/43 • Up to 1 year
|
|
Metabolism and nutrition disorders
Anorexia
|
2.3%
1/43 • Up to 1 year
|
4.7%
2/43 • Up to 1 year
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/43 • Up to 1 year
|
11.6%
5/43 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/43 • Up to 1 year
|
2.3%
1/43 • Up to 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/43 • Up to 1 year
|
2.3%
1/43 • Up to 1 year
|
|
Infections and infestations
Bacteremia
|
2.3%
1/43 • Up to 1 year
|
0.00%
0/43 • Up to 1 year
|
|
Hepatobiliary disorders
Biliary duct obstruction
|
2.3%
1/43 • Up to 1 year
|
9.3%
4/43 • Up to 1 year
|
|
Infections and infestations
Biliary tract infection
|
2.3%
1/43 • Up to 1 year
|
0.00%
0/43 • Up to 1 year
|
|
Investigations
Blood bilirubin increased
|
4.7%
2/43 • Up to 1 year
|
2.3%
1/43 • Up to 1 year
|
|
Investigations
Cardiac troponin increased
|
2.3%
1/43 • Up to 1 year
|
0.00%
0/43 • Up to 1 year
|
|
General disorders
Chills
|
0.00%
0/43 • Up to 1 year
|
2.3%
1/43 • Up to 1 year
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/43 • Up to 1 year
|
4.7%
2/43 • Up to 1 year
|
|
Gastrointestinal disorders
Colitis
|
4.7%
2/43 • Up to 1 year
|
7.0%
3/43 • Up to 1 year
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/43 • Up to 1 year
|
2.3%
1/43 • Up to 1 year
|
|
Psychiatric disorders
Confusion
|
0.00%
0/43 • Up to 1 year
|
7.0%
3/43 • Up to 1 year
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/43 • Up to 1 year
|
4.7%
2/43 • Up to 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/43 • Up to 1 year
|
7.0%
3/43 • Up to 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
2.3%
1/43 • Up to 1 year
|
7.0%
3/43 • Up to 1 year
|
|
Gastrointestinal disorders
Duodenal obstruction
|
2.3%
1/43 • Up to 1 year
|
0.00%
0/43 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.7%
2/43 • Up to 1 year
|
9.3%
4/43 • Up to 1 year
|
|
General disorders
Edema limbs
|
2.3%
1/43 • Up to 1 year
|
0.00%
0/43 • Up to 1 year
|
|
Nervous system disorders
Encephalopathy
|
2.3%
1/43 • Up to 1 year
|
4.7%
2/43 • Up to 1 year
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/43 • Up to 1 year
|
2.3%
1/43 • Up to 1 year
|
|
Nervous system disorders
Facial muscle weakness
|
0.00%
0/43 • Up to 1 year
|
2.3%
1/43 • Up to 1 year
|
|
General disorders
Fatigue
|
2.3%
1/43 • Up to 1 year
|
7.0%
3/43 • Up to 1 year
|
|
General disorders
Fever
|
0.00%
0/43 • Up to 1 year
|
11.6%
5/43 • Up to 1 year
|
|
Injury, poisoning and procedural complications
Bone fracture
|
0.00%
0/43 • Up to 1 year
|
2.3%
1/43 • Up to 1 year
|
|
Infections and infestations
Fungemia
|
2.3%
1/43 • Up to 1 year
|
0.00%
0/43 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/43 • Up to 1 year
|
2.3%
1/43 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.3%
1/43 • Up to 1 year
|
0.00%
0/43 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.3%
1/43 • Up to 1 year
|
0.00%
0/43 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/43 • Up to 1 year
|
2.3%
1/43 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/43 • Up to 1 year
|
2.3%
1/43 • Up to 1 year
|
|
Vascular disorders
Hypotension
|
9.3%
4/43 • Up to 1 year
|
7.0%
3/43 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.3%
1/43 • Up to 1 year
|
7.0%
3/43 • Up to 1 year
|
|
Gastrointestinal disorders
Ileal obstruction
|
2.3%
1/43 • Up to 1 year
|
0.00%
0/43 • Up to 1 year
|
|
General disorders
Infusion related reaction
|
2.3%
1/43 • Up to 1 year
|
0.00%
0/43 • Up to 1 year
|
|
Infections and infestations
Lung infection
|
0.00%
0/43 • Up to 1 year
|
2.3%
1/43 • Up to 1 year
|
|
General disorders
Malaise
|
0.00%
0/43 • Up to 1 year
|
2.3%
1/43 • Up to 1 year
|
|
Infections and infestations
Meningitis
|
2.3%
1/43 • Up to 1 year
|
0.00%
0/43 • Up to 1 year
|
|
General disorders
Multi-organ failure
|
0.00%
0/43 • Up to 1 year
|
2.3%
1/43 • Up to 1 year
|
|
Cardiac disorders
Myocardial infarction
|
2.3%
1/43 • Up to 1 year
|
0.00%
0/43 • Up to 1 year
|
|
Cardiac disorders
Myocarditis
|
2.3%
1/43 • Up to 1 year
|
2.3%
1/43 • Up to 1 year
|
|
Gastrointestinal disorders
Nausea
|
4.7%
2/43 • Up to 1 year
|
4.7%
2/43 • Up to 1 year
|
|
Gastrointestinal disorders
Gastric obstruction
|
4.7%
2/43 • Up to 1 year
|
0.00%
0/43 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain
|
2.3%
1/43 • Up to 1 year
|
0.00%
0/43 • Up to 1 year
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/43 • Up to 1 year
|
2.3%
1/43 • Up to 1 year
|
|
Infections and infestations
Peritoneal infection
|
2.3%
1/43 • Up to 1 year
|
0.00%
0/43 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.3%
1/43 • Up to 1 year
|
4.7%
2/43 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/43 • Up to 1 year
|
2.3%
1/43 • Up to 1 year
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/43 • Up to 1 year
|
7.0%
3/43 • Up to 1 year
|
|
Nervous system disorders
Presyncope
|
2.3%
1/43 • Up to 1 year
|
0.00%
0/43 • Up to 1 year
|
|
Infections and infestations
Sepsis
|
2.3%
1/43 • Up to 1 year
|
11.6%
5/43 • Up to 1 year
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/43 • Up to 1 year
|
2.3%
1/43 • Up to 1 year
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/43 • Up to 1 year
|
2.3%
1/43 • Up to 1 year
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/43 • Up to 1 year
|
2.3%
1/43 • Up to 1 year
|
|
Nervous system disorders
Syncope
|
2.3%
1/43 • Up to 1 year
|
4.7%
2/43 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/43 • Up to 1 year
|
2.3%
1/43 • Up to 1 year
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/43 • Up to 1 year
|
2.3%
1/43 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
Herpes zoster
|
0.00%
0/43 • Up to 1 year
|
2.3%
1/43 • Up to 1 year
|
|
Renal and urinary disorders
Ureteral obstruction
|
2.3%
1/43 • Up to 1 year
|
0.00%
0/43 • Up to 1 year
|
|
Renal and urinary disorders
Urinary retention
|
2.3%
1/43 • Up to 1 year
|
0.00%
0/43 • Up to 1 year
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/43 • Up to 1 year
|
4.7%
2/43 • Up to 1 year
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/43 • Up to 1 year
|
2.3%
1/43 • Up to 1 year
|
|
Nervous system disorders
Vasovagal reaction
|
0.00%
0/43 • Up to 1 year
|
2.3%
1/43 • Up to 1 year
|
|
Infections and infestations
Viral infection
|
2.3%
1/43 • Up to 1 year
|
0.00%
0/43 • Up to 1 year
|
|
Gastrointestinal disorders
Vomiting
|
7.0%
3/43 • Up to 1 year
|
11.6%
5/43 • Up to 1 year
|
|
General disorders
Disease Progression
|
74.4%
32/43 • Up to 1 year
|
72.1%
31/43 • Up to 1 year
|
|
Nervous system disorders
Stroke
|
0.00%
0/43 • Up to 1 year
|
2.3%
1/43 • Up to 1 year
|
|
General disorders
Death NOS
|
4.7%
2/43 • Up to 1 year
|
4.7%
2/43 • Up to 1 year
|
Other adverse events
| Measure |
Arm A (Atezolizumab)
n=43 participants at risk
Patients receive atezolizumab IV over 30-60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Atezolizumab, Cobimetinib)
n=43 participants at risk
Patients receive atezolizumab IV over 30-60 minutes on days 1 and 15 and cobimetinib PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
4.7%
2/43 • Up to 1 year
|
7.0%
3/43 • Up to 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
32.6%
14/43 • Up to 1 year
|
34.9%
15/43 • Up to 1 year
|
|
Investigations
Alanine aminotransferase (ALT) increased
|
23.3%
10/43 • Up to 1 year
|
20.9%
9/43 • Up to 1 year
|
|
Investigations
Alkaline phosphatase increased
|
27.9%
12/43 • Up to 1 year
|
39.5%
17/43 • Up to 1 year
|
|
Immune system disorders
Allergic reaction
|
7.0%
3/43 • Up to 1 year
|
0.00%
0/43 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
4.7%
2/43 • Up to 1 year
|
2.3%
1/43 • Up to 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
30.2%
13/43 • Up to 1 year
|
37.2%
16/43 • Up to 1 year
|
|
Metabolism and nutrition disorders
Anorexia
|
20.9%
9/43 • Up to 1 year
|
16.3%
7/43 • Up to 1 year
|
|
Psychiatric disorders
Anxiety
|
4.7%
2/43 • Up to 1 year
|
2.3%
1/43 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.7%
2/43 • Up to 1 year
|
2.3%
1/43 • Up to 1 year
|
|
Gastrointestinal disorders
Ascites
|
9.3%
4/43 • Up to 1 year
|
9.3%
4/43 • Up to 1 year
|
|
Investigations
Aspartate aminotransferase (AST) increased
|
34.9%
15/43 • Up to 1 year
|
32.6%
14/43 • Up to 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/43 • Up to 1 year
|
4.7%
2/43 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.0%
3/43 • Up to 1 year
|
7.0%
3/43 • Up to 1 year
|
|
Gastrointestinal disorders
Belching
|
0.00%
0/43 • Up to 1 year
|
4.7%
2/43 • Up to 1 year
|
|
Gastrointestinal disorders
Bloating
|
11.6%
5/43 • Up to 1 year
|
7.0%
3/43 • Up to 1 year
|
|
Investigations
Blood bilirubin increased
|
16.3%
7/43 • Up to 1 year
|
7.0%
3/43 • Up to 1 year
|
|
General disorders
Chills
|
11.6%
5/43 • Up to 1 year
|
9.3%
4/43 • Up to 1 year
|
|
Gastrointestinal disorders
Constipation
|
16.3%
7/43 • Up to 1 year
|
25.6%
11/43 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.9%
9/43 • Up to 1 year
|
11.6%
5/43 • Up to 1 year
|
|
Investigations
Creatinine increased
|
14.0%
6/43 • Up to 1 year
|
7.0%
3/43 • Up to 1 year
|
|
Investigations
Creatinine kinase (CK) increased
|
0.00%
0/43 • Up to 1 year
|
20.9%
9/43 • Up to 1 year
|
|
Metabolism and nutrition disorders
Dehyrdation
|
11.6%
5/43 • Up to 1 year
|
9.3%
4/43 • Up to 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
32.6%
14/43 • Up to 1 year
|
53.5%
23/43 • Up to 1 year
|
|
Nervous system disorders
Dizziness
|
9.3%
4/43 • Up to 1 year
|
16.3%
7/43 • Up to 1 year
|
|
Eye disorders
Dry eye
|
0.00%
0/43 • Up to 1 year
|
4.7%
2/43 • Up to 1 year
|
|
Gastrointestinal disorders
Dry mouth
|
2.3%
1/43 • Up to 1 year
|
16.3%
7/43 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.3%
1/43 • Up to 1 year
|
7.0%
3/43 • Up to 1 year
|
|
Nervous system disorders
Dysgeusia
|
4.7%
2/43 • Up to 1 year
|
7.0%
3/43 • Up to 1 year
|
|
Gastrointestinal disorders
Dyspepsia
|
7.0%
3/43 • Up to 1 year
|
2.3%
1/43 • Up to 1 year
|
|
Gastrointestinal disorders
Dysphagia
|
4.7%
2/43 • Up to 1 year
|
2.3%
1/43 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.0%
6/43 • Up to 1 year
|
20.9%
9/43 • Up to 1 year
|
|
General disorders
Edema
|
9.3%
4/43 • Up to 1 year
|
37.2%
16/43 • Up to 1 year
|
|
General disorders
Fatigue
|
46.5%
20/43 • Up to 1 year
|
55.8%
24/43 • Up to 1 year
|
|
General disorders
Fever
|
20.9%
9/43 • Up to 1 year
|
30.2%
13/43 • Up to 1 year
|
|
Gastrointestinal disorders
Flatulence
|
4.7%
2/43 • Up to 1 year
|
9.3%
4/43 • Up to 1 year
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease (GERD)
|
2.3%
1/43 • Up to 1 year
|
9.3%
4/43 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
4.7%
2/43 • Up to 1 year
|
9.3%
4/43 • Up to 1 year
|
|
Nervous system disorders
Headache
|
9.3%
4/43 • Up to 1 year
|
9.3%
4/43 • Up to 1 year
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/43 • Up to 1 year
|
4.7%
2/43 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
7.0%
3/43 • Up to 1 year
|
4.7%
2/43 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.0%
3/43 • Up to 1 year
|
27.9%
12/43 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
4.7%
2/43 • Up to 1 year
|
4.7%
2/43 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.3%
1/43 • Up to 1 year
|
9.3%
4/43 • Up to 1 year
|
|
Vascular disorders
Hypertension
|
30.2%
13/43 • Up to 1 year
|
20.9%
9/43 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
25.6%
11/43 • Up to 1 year
|
44.2%
19/43 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
4.7%
2/43 • Up to 1 year
|
16.3%
7/43 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.6%
11/43 • Up to 1 year
|
14.0%
6/43 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
11.6%
5/43 • Up to 1 year
|
14.0%
6/43 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
27.9%
12/43 • Up to 1 year
|
27.9%
12/43 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hypophosphotemia
|
7.0%
3/43 • Up to 1 year
|
7.0%
3/43 • Up to 1 year
|
|
Vascular disorders
Hypotension
|
4.7%
2/43 • Up to 1 year
|
0.00%
0/43 • Up to 1 year
|
|
Endocrine disorders
Hypothyroidism
|
9.3%
4/43 • Up to 1 year
|
7.0%
3/43 • Up to 1 year
|
|
General disorders
Infusion-related reaction
|
9.3%
4/43 • Up to 1 year
|
4.7%
2/43 • Up to 1 year
|
|
Psychiatric disorders
Insomnia
|
4.7%
2/43 • Up to 1 year
|
11.6%
5/43 • Up to 1 year
|
|
Investigations
Lipase increased
|
2.3%
1/43 • Up to 1 year
|
9.3%
4/43 • Up to 1 year
|
|
Investigations
Lymphocyte count decreased
|
30.2%
13/43 • Up to 1 year
|
39.5%
17/43 • Up to 1 year
|
|
General disorders
Malaise
|
4.7%
2/43 • Up to 1 year
|
0.00%
0/43 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.7%
2/43 • Up to 1 year
|
2.3%
1/43 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/43 • Up to 1 year
|
7.0%
3/43 • Up to 1 year
|
|
Gastrointestinal disorders
Nausea
|
27.9%
12/43 • Up to 1 year
|
39.5%
17/43 • Up to 1 year
|
|
Investigations
Neutrophil count decreased
|
7.0%
3/43 • Up to 1 year
|
9.3%
4/43 • Up to 1 year
|
|
General disorders
Non-cardiac chest pain
|
4.7%
2/43 • Up to 1 year
|
0.00%
0/43 • Up to 1 year
|
|
Gastrointestinal disorders
Oral pain
|
4.7%
2/43 • Up to 1 year
|
0.00%
0/43 • Up to 1 year
|
|
General disorders
Pain
|
18.6%
8/43 • Up to 1 year
|
20.9%
9/43 • Up to 1 year
|
|
Nervous system disorders
Peripheral neuropathy
|
4.7%
2/43 • Up to 1 year
|
9.3%
4/43 • Up to 1 year
|
|
Investigations
Platelet count decreased
|
20.9%
9/43 • Up to 1 year
|
48.8%
21/43 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.7%
2/43 • Up to 1 year
|
4.7%
2/43 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
2.3%
1/43 • Up to 1 year
|
7.0%
3/43 • Up to 1 year
|
|
Renal and urinary disorders
Proteinuria
|
4.7%
2/43 • Up to 1 year
|
4.7%
2/43 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.7%
2/43 • Up to 1 year
|
20.9%
9/43 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.3%
4/43 • Up to 1 year
|
69.8%
30/43 • Up to 1 year
|
|
Cardiac disorders
Sinus bradycardia
|
2.3%
1/43 • Up to 1 year
|
4.7%
2/43 • Up to 1 year
|
|
Cardiac disorders
Sinus tachycardia
|
4.7%
2/43 • Up to 1 year
|
4.7%
2/43 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/43 • Up to 1 year
|
4.7%
2/43 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
2.3%
1/43 • Up to 1 year
|
7.0%
3/43 • Up to 1 year
|
|
Infections and infestations
Thrush
|
7.0%
3/43 • Up to 1 year
|
0.00%
0/43 • Up to 1 year
|
|
Gastrointestinal disorders
Vomiting
|
23.3%
10/43 • Up to 1 year
|
41.9%
18/43 • Up to 1 year
|
|
Investigations
Weight loss
|
11.6%
5/43 • Up to 1 year
|
4.7%
2/43 • Up to 1 year
|
|
Investigations
White blood cell decreased
|
16.3%
7/43 • Up to 1 year
|
16.3%
7/43 • Up to 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60