A Phase 2 interventional study of Cobimetinib and Atezolizumab in Solid Tumors, sponsored by Hoffmann-La Roche. Completed at 19 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-11.
Sponsored by Hoffmann-La Roche · Phase 2, Interventional, and Treatment
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This is a study to evaluate the efficacy, safety, and pharmacokinetics of cobimetinib plus atezolizumab in participants with advanced solid tumors including the following cohorts: squamous cell carcinoma of the head and neck (SCCHN), urothelial carcinoma (UC), and renal cell carcinoma (RCC).
Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 88 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
General Inclusion Criteria:
Cancer-Related Inclusion Criteria:
Exclusion Criteria:
General Exclusion Criteria:
Exclusion Criteria based on Organ Function or Medical History
Cardiovascular
Patients who meet the following cardiovascular exclusion criterion will be excluded from study entry:
Infections Patients who meet any of the following infection exclusion criteria will be excluded from study entry:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In participants with recurrent or advanced / metastatic SSCHN who are anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib will be administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
Drug: Cobimetinib · Drug: Atezolizumab
In participants with advanced / metastatic UC who are anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib will be administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
Drug: Cobimetinib · Drug: Atezolizumab
In participants with metastatic RCC who are anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib will be administered at the approved dose and schedule of 60 milligrams (mg) once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
Drug: Cobimetinib · Drug: Atezolizumab
In participants with SCCHN whose disease has progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib will be administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
Drug: Cobimetinib · Drug: Atezolizumab
In participants with UC whose disease has progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib will be administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
Drug: Cobimetinib · Drug: Atezolizumab
In participants with RCC whose disease has progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib will be administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
Drug: Cobimetinib · Drug: Atezolizumab
In participants with solid non-melanoma, non- hematologic tumors who previously developed primary or secondary resistance to an anti-PD-1 or anti-PD-L1 agent, cobimetinib will be administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle. The first dose of atezolizumab of 840 mg by IV infusions on Day 15 of Cycle 1. Thereafter, they will receive atezolizumab 840 mg IV infusion Q2W on Days 1 and 15 of Cycle 2 and all subsequent cycles.
Drug: Cobimetinib · Drug: Atezolizumab Cohort 7
Participants will receive cobimetinib 60 mg (3 tablets of 20 mg each) orally once a day on Days 1-21 of each 28-day cycle.
Also known as: Cotellic
Atezolizumab will be given at a fixed dose of 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
Also known as: Tecentriq
Only for participants in cohort 7, the first dose of atezolizumab of 840 mg will be given by IV infusion on Day 15 of Cycle 1; thereafter, they will receive atezolizumab 840 mg IV infusion Q2W on Days 1 and 15 of Cycle 2 and all subsequent cycles.
Also known as: Tecentriq
Objective Response Rate (ORR)
Objective response rate was defined as the percentage of participants with a complete response (CR) or a partial response (PR) on two consecutive tumor assessments ≥4 weeks apart, as determined by the investigators using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). CR was defined as disappearance of all lesions. PR was defined as ≥30% decrease in the sum of diameters of target lesions, in the absence of CR, new lesions, and unequivocal progression in non-target lesions.
Time frame: Up to approximately 31 months
Overall Survival (OS)
Overall survival was defined as the time from enrollment to death from any cause. The median for OS is Kaplan-Meier estimate. 95% CI for median was computed using the method of Brookmeyer and Crowley.
Time frame: Up to approximately 31 months
Progression-Free Survival (PFS)
PFS was defined as the time from enrollment to the first occurrence of disease progression as determined by the investigator(s), using RECIST v1.1, or to death from any cause, whichever occurs first. Disease progression was defined as ≥20% increase in in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions.
Time frame: Up to approximately 31 months
Duration of Response (DOR)
DOR was defined as the time from the first occurrence of a documented, confirmed objective response to disease progression as determined by the investigator, using RECIST v1.1, or to death from any cause, whichever occurs first. Objective response was defined as a complete response (CR) or a partial response (PR) on two consecutive tumor assessments ≥4 weeks apart. CR was defined as disappearance of all lesions. PR was defined as ≥30% decrease in the sum of diameters of target lesions, in the absence of CR, new lesions, and unequivocal progression in non-target lesions. Disease progression was defined as ≥20% increase in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions. Presented here is median DOR at the time of primary analysis. The median for the duration of response is Kaplan-Meier estimate. 95% CI for median was computed using the method of Brookmeyer and Crowley.
Time frame: Up to approximately 22 months
Disease Control Rate (DCR)
DCR was defined as the percentage of participants with a complete response (CR), a partial response (PR), or stable disease at 16 weeks as determined by the investigator using RECIST v1.1. CR was defined as disappearance of all lesions. PR was defined as ≥30% decrease in the sum of diameters of target lesions, in the absence of CR, new lesions, and unequivocal progression in non-target lesions. Stable disease was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for disease progression. Disease progression was defined as ≥20% increase in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions.
Time frame: At 16 weeks
Number of Participants With Adverse Events
An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Time frame: Up to approximately 31 months
Maximum Plasma Concentration (Cmax) of Cobimetinib
Cmax is the maximum (or peak) concentration that a study drug achieves in the body.
Time frame: Day 15 of Cycle 3 (cycle is 28 days): 2-4 hours after cobimetinib dose
Minimum Plasma Concentration (Cmin) of Cobimetinib
Cmin is the minimum (or trough) concentration that a study drug achieves in the body.
Time frame: Day 15 of Cycle 3 (cycle is 28 days): prior to cobimetinib dose
Maximum Serum Concentration (Cmax) of Atezolizumab
Cmax is the maximum (or peak) concentration that a study drug achieves in the body.
Time frame: 30 minutes following end of atezolizumab infusion on Day 15 of Cycle 3 (each cycle is 28 days)
Minimum Serum Concentration (Cmin) of Atezolizumab
Cmin is the minimum (or trough) concentration that a study drug achieves in the body.
Time frame: Prior to atezolizumab infusion on Day 1 of Cycles (each cycle is 28 days) 2, 4, 8, 12, and 16, Day 15 of Cycle 3
Number of Participants With Anti-drug Antibodies (ADAs)
Participants were considered to be ADA positive if they were missing data at baseline but developed an ADA response following study drug administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was at least 4-fold greater (i.e., ≥0.60-titer units) than the titer of the baseline sample (treatment-enhanced ADA response). Participants were considered to be ADA negative if they were missing data at baseline, had a post-baseline ADA result, and all post-baseline samples were negative, or if they were ADA positive at baseline but did not have any post-baseline samples with a titer that was at least 4-fold greater than the titer of the baseline sample (treatment unaffected).
Time frame: Day 1 of Cycles (each cycle is 28 days) 1, 2, 4, 8, 12, and 16; Day 15 of Cycle 3; at atezolizumab treatment discontinuation visit, and <90 days after last atezolizumab infusion (up to approximately 31 months)
Enrollment took place in six countries: Republic of Korea, Belgium, Germany, United Kingdom, Hungary and United States. No participants were enrolled in Cohort 7. Participants in long term follow up and who continued to receive treatment(s) in a post-trial access program are designated in Participant Flow as "Study terminated by Sponsor".
| Milestone | Cohort 1 - SCCHN - Treatment Naive | Cohort 2 - UC - Treatment Naive | Cohort 3 - RCC - Treatment Naive | Cohort 4 - SCCHN - Previous Treatment Exposure | Cohort 5 - UC - Previous Treatment Exposure | Cohort 6 - RCC - Previous Treatment Exposure |
|---|---|---|---|---|---|---|
| Started | 20 | 20 | 17 | 20 | 7 | 3 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 20 | 20 | 17 | 20 | 7 | 3 |
| Withdrew: Adverse event | 1 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Death | 12 | 12 | 8 | 10 | 6 | 1 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Progressive disease | 0 | 2 | 1 | 0 | 0 | 0 |
| Withdrew: Study terminated by sponsor | 5 | 5 | 8 | 5 | 1 | 2 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 | 5 | 0 | 0 |
Objective response rate was defined as the percentage of participants with a complete response (CR) or a partial response (PR) on two consecutive tumor assessments ≥4 weeks apart, as determined by the investigators using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). CR was defined as disappearance of all lesions. PR was defined as ≥30% decrease in the sum of diameters of target lesions, in the absence of CR, new lesions, and unequivocal progression in non-target lesions.
| percentage of participants | Cohort 1 - SCCHN - Treatment Naive | Cohort 2 - UC - Treatment Naive | Cohort 3 - RCC - Treatment Naive | Cohort 4 - SCCHN - Previous Treatment Exposure | Cohort 5 - UC - Previous Treatment Exposure | Cohort 6 - RCC - Previous Treatment Exposure |
|---|---|---|---|---|---|---|
| Objective Response Rate (ORR) | 20.0 (0.00 to 40.03) | 30.0 (7.42 to 52.58) | 17.6 (0.00 to 38.71) | 0 (0.00 to 2.50) | 0 (0.00 to 7.14) | 0 (0.00 to 16.67) |
Overall survival was defined as the time from enrollment to death from any cause. The median for OS is Kaplan-Meier estimate. 95% CI for median was computed using the method of Brookmeyer and Crowley.
| months | Cohort 1 - SCCHN - Treatment Naive | Cohort 2 - UC - Treatment Naive | Cohort 3 - RCC - Treatment Naive | Cohort 4 - SCCHN - Previous Treatment Exposure | Cohort 5 - UC - Previous Treatment Exposure | Cohort 6 - RCC - Previous Treatment Exposure |
|---|---|---|---|---|---|---|
| Overall Survival (OS) | 16.8 (6.9 to 25.8) | 18.7 (11.0 to 26.2) | 21.7 (17.4 to NA) | 7.7 (4.0 to NA) | 5.9 (3.1 to 12.5) | NA (5.9 to NA) |
PFS was defined as the time from enrollment to the first occurrence of disease progression as determined by the investigator(s), using RECIST v1.1, or to death from any cause, whichever occurs first. Disease progression was defined as ≥20% increase in in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions.
| months | Cohort 1 - SCCHN - Treatment Naive | Cohort 2 - UC - Treatment Naive | Cohort 3 - RCC - Treatment Naive | Cohort 4 - SCCHN - Previous Treatment Exposure | Cohort 5 - UC - Previous Treatment Exposure | Cohort 6 - RCC - Previous Treatment Exposure |
|---|---|---|---|---|---|---|
| Progression-Free Survival (PFS) | 5.5 (2 to 26) | 3.4 (2 to 26) | 3.4 (1 to 28) | 3.6 (0 to 9) | 2.1 (1 to 4) | 2.7 (1 to 4) |
DOR was defined as the time from the first occurrence of a documented, confirmed objective response to disease progression as determined by the investigator, using RECIST v1.1, or to death from any cause, whichever occurs first. Objective response was defined as a complete response (CR) or a partial response (PR) on two consecutive tumor assessments ≥4 weeks apart. CR was defined as disappearance of all lesions. PR was defined as ≥30% decrease in the sum of diameters of target lesions, in the absence of CR, new lesions, and unequivocal progression in non-target lesions. Disease progression was defined as ≥20% increase in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions. Presented here is median DOR at the time of primary analysis. The median for the duration of response is Kaplan-Meier estimate. 95% CI for median was computed using the method of Brookmeyer and Crowley.
| days | Cohort 1 - SCCHN - Treatment Naive | Cohort 2 - UC - Treatment Naive | Cohort 3 - RCC - Treatment Naive | Cohort 4 - SCCHN - Previous Treatment Exposure | Cohort 5 - UC - Previous Treatment Exposure | Cohort 6 - RCC - Previous Treatment Exposure |
|---|---|---|---|---|---|---|
| Duration of Response (DOR) | NA (NA to NA) | 149.0 (125.0 to 173.0) | NA (NA to NA) | — | — | — |
DCR was defined as the percentage of participants with a complete response (CR), a partial response (PR), or stable disease at 16 weeks as determined by the investigator using RECIST v1.1. CR was defined as disappearance of all lesions. PR was defined as ≥30% decrease in the sum of diameters of target lesions, in the absence of CR, new lesions, and unequivocal progression in non-target lesions. Stable disease was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for disease progression. Disease progression was defined as ≥20% increase in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions.
| percentage of participants | Cohort 1 - SCCHN - Treatment Naive | Cohort 2 - UC - Treatment Naive | Cohort 3 - RCC - Treatment Naive | Cohort 4 - SCCHN - Previous Treatment Exposure | Cohort 5 - UC - Previous Treatment Exposure | Cohort 6 - RCC - Previous Treatment Exposure |
|---|---|---|---|---|---|---|
| Disease Control Rate (DCR) | 50.0 (25.59 to 74.41) | 40.0 (16.03 to 63.97) | 23.5 (0.42 to 46.63) | 25.0 (3.52 to 46.48) | 0 (0.00 to 7.14) | 0 (0.00 to 16.67) |
An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
| participants | Cohort 1 - SCCHN - Treatment Naive | Cohort 2 - UC - Treatment Naive | Cohort 3 - RCC - Treatment Naive | Cohort 4 - SCCHN - Previous Treatment Exposure | Cohort 5 - UC - Previous Treatment Exposure | Cohort 6 - RCC - Previous Treatment Exposure |
|---|---|---|---|---|---|---|
| Number of Participants With Adverse Events | 20 | 19 | 17 | 20 | 7 | 3 |
Cmax is the maximum (or peak) concentration that a study drug achieves in the body.
| nanogram per milliliter (ng/mL) | Cohorts 1-6 |
|---|---|
| Maximum Plasma Concentration (Cmax) of Cobimetinib | 285 ± 56.5 |
Cmin is the minimum (or trough) concentration that a study drug achieves in the body.
| ng/mL | Cohorts 1-6 |
|---|---|
| Minimum Plasma Concentration (Cmin) of Cobimetinib | 174 ± 152 |
Cmax is the maximum (or peak) concentration that a study drug achieves in the body.
| ng/mL | Cohorts 1-6 |
|---|---|
| Maximum Serum Concentration (Cmax) of Atezolizumab | 417000 ± 50.2 |
Cmin is the minimum (or trough) concentration that a study drug achieves in the body.
| ng/mL | Cohorts 1-6 |
|---|---|
| Minimum Serum Concentration (Cmin) of Atezolizumab | 112000 ± 219 |
Participants were considered to be ADA positive if they were missing data at baseline but developed an ADA response following study drug administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was at least 4-fold greater (i.e., ≥0.60-titer units) than the titer of the baseline sample (treatment-enhanced ADA response). Participants were considered to be ADA negative if they were missing data at baseline, had a post-baseline ADA result, and all post-baseline samples were negative, or if they were ADA positive at baseline but did not have any post-baseline samples with a titer that was at least 4-fold greater than the titer of the baseline sample (treatment unaffected).
| Participants | Cohort 1 - SCCHN - Treatment Naive | Cohort 2 - UC - Treatment Naive | Cohort 3 - RCC - Treatment Naive | Cohort 4 - SCCHN - Previous Treatment Exposure | Cohort 5 - UC - Previous Treatment Exposure | Cohort 6 - RCC - Previous Treatment Exposure |
|---|---|---|---|---|---|---|
| Number of Participants With Anti-drug Antibodies (ADAs) | 1 | 10 | 6 | 5 | 0 | 2 |
Collected over Up to approximately 31 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1 - SCCHN - Treatment Naive | 12/20 (60%) | 13/20 (65%) | 20/20 (100%) |
| Cohort 2 - UC - Treatment Naive | 12/19 (63.2%) | 9/19 (47.4%) | 19/19 (100%) |
| Cohort 3 - RCC - Treatment Naive | 8/17 (47.1%) | 8/17 (47.1%) | 17/17 (100%) |
| Cohort 4 - SCCHN - Previous Treatment Exposure | 12/20 (60%) | 10/20 (50%) | 19/20 (95%) |
| Cohort 5 - UC - Previous Treatment Exposure | 6/7 (85.7%) | 4/7 (57.1%) | 7/7 (100%) |
| Cohort 6 - RCC - Previous Treatment Exposure | 1/3 (33.3%) | 1/3 (33.3%) | 3/3 (100%) |
| Event | Cohort 1 - SCCHN - Treatment Naive | Cohort 2 - UC - Treatment Naive | Cohort 3 - RCC - Treatment Naive | Cohort 4 - SCCHN - Previous Treatment Exposure | Cohort 5 - UC - Previous Treatment Exposure | Cohort 6 - RCC - Previous Treatment Exposure |
|---|---|---|---|---|---|---|
| DIARRHOEAGastrointestinal disorders | 0/20 | 0/19 | 2/17 | 0/20 | 1/7 | 1/3 |
| NAUSEAGastrointestinal disorders | 0/20 | 0/19 | 0/17 | 0/20 | 0/7 | 1/3 |
| ASTHENIAGeneral disorders | 0/20 | 0/19 | 0/17 | 0/20 | 0/7 | 1/3 |
| CHILLSGeneral disorders | 0/20 | 0/19 | 0/17 | 0/20 | 0/7 | 1/3 |
| FATIGUEGeneral disorders | 0/20 | 0/19 | 0/17 | 0/20 | 0/7 | 1/3 |
| PYREXIAGeneral disorders | 0/20 | 0/19 | 0/17 | 1/20 | 0/7 | 1/3 |
| PHARYNGITIS STREPTOCOCCALInfections and infestations | 0/20 | 0/19 | 0/17 | 0/20 | 0/7 | 1/3 |
| PULMONARY EMBOLISMRespiratory, thoracic and mediastinal disorders | 0/20 | 1/19 | 0/17 | 0/20 | 0/7 | 1/3 |
| PNEUMONIAInfections and infestations | 3/20 | 2/19 | 2/17 | 2/20 | 0/7 | 0/3 |
| IMMUNE-MEDIATED HEPATITISHepatobiliary disorders | 0/20 | 0/19 | 0/17 | 0/20 | 1/7 | 0/3 |
| Event | Cohort 1 - SCCHN - Treatment Naive | Cohort 2 - UC - Treatment Naive | Cohort 3 - RCC - Treatment Naive | Cohort 4 - SCCHN - Previous Treatment Exposure | Cohort 5 - UC - Previous Treatment Exposure | Cohort 6 - RCC - Previous Treatment Exposure |
|---|---|---|---|---|---|---|
| DIARRHOEAGastrointestinal disorders | 7/20 | 11/19 | 9/17 | 13/20 | 5/7 | 2/3 |
| FATIGUEGeneral disorders | 6/20 | 9/19 | 5/17 | 5/20 | 5/7 | 0/3 |
| RASHSkin and subcutaneous tissue disorders | 9/20 | 9/19 | 12/17 | 5/20 | 5/7 | 1/3 |
| NAUSEAGastrointestinal disorders | 6/20 | 3/19 | 5/17 | 6/20 | 4/7 | 0/3 |
| PYREXIAGeneral disorders | 2/20 | 7/19 | 5/17 | 1/20 | 4/7 | 0/3 |
| URINARY TRACT INFECTIONInfections and infestations | 0/20 | 4/19 | 2/17 | 0/20 | 4/7 | 0/3 |
| BLOOD CREATINE PHOSPHOKINASE INCREASEDInvestigations | 4/20 | 7/19 | 3/17 | 1/20 | 3/7 | 0/3 |
| DYSURIARenal and urinary disorders | 0/20 | 2/19 | 0/17 | 0/20 | 3/7 | 0/3 |
| PRURITUSSkin and subcutaneous tissue disorders | 2/20 | 3/19 | 1/17 | 4/20 | 3/7 | 0/3 |
| ANAEMIABlood and lymphatic system disorders | 8/20 | 6/19 | 4/17 | 2/20 | 1/7 | 0/3 |
The intent-to-treat (ITT) population included all participants enrolled in the study.
| Age, Customized(Participants) | Cohort 1 - SCCHN - Treatment Naive | Cohort 2 - UC - Treatment Naive | Cohort 3 - RCC - Treatment Naive | Cohort 4 - SCCHN - Previous Treatment Exposure | Cohort 5 - UC - Previous Treatment Exposure | Cohort 6 - RCC - Previous Treatment Exposure | Total |
|---|---|---|---|---|---|---|---|
| Adults (18-64 years) | 12 | 6 | 10 | 12 | 3 | 1 | 44 |
| From 65-84 years | 8 | 13 | 7 | 8 | 4 | 2 | 42 |
| Missing | 0 | 1 | 0 | 0 | 0 | 0 | 1 |
| Sex: Female, Male(Participants) | Cohort 1 - SCCHN - Treatment Naive | Cohort 2 - UC - Treatment Naive | Cohort 3 - RCC - Treatment Naive | Cohort 4 - SCCHN - Previous Treatment Exposure | Cohort 5 - UC - Previous Treatment Exposure | Cohort 6 - RCC - Previous Treatment Exposure | Total |
|---|---|---|---|---|---|---|---|
| Female | 2 | 8 | 6 | 1 | 2 | 2 | 21 |
| Male | 18 | 12 | 11 | 19 | 5 | 1 | 66 |
| Ethnicity (NIH/OMB)(Participants) | Cohort 1 - SCCHN - Treatment Naive | Cohort 2 - UC - Treatment Naive | Cohort 3 - RCC - Treatment Naive | Cohort 4 - SCCHN - Previous Treatment Exposure | Cohort 5 - UC - Previous Treatment Exposure | Cohort 6 - RCC - Previous Treatment Exposure | Total |
|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| Not Hispanic or Latino | 15 | 20 | 17 | 19 | 7 | 2 | 80 |
| Unknown or Not Reported | 5 | 0 | 0 | 1 | 0 | 0 | 6 |
| Race (NIH/OMB)(Participants) | Cohort 1 - SCCHN - Treatment Naive | Cohort 2 - UC - Treatment Naive | Cohort 3 - RCC - Treatment Naive | Cohort 4 - SCCHN - Previous Treatment Exposure | Cohort 5 - UC - Previous Treatment Exposure | Cohort 6 - RCC - Previous Treatment Exposure | Total |
|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 2 | 10 | 10 | 0 | 2 | 0 | 24 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| White | 18 | 10 | 7 | 20 | 5 | 3 | 63 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Nov 2017 to primary completion in Jun 2020, 31 months.
Results were first posted in Mar 2021, 8 months after primary completion. A results delay was requested in Jun 2020.
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Studies of the drugs tested here: Cobimetinib · Atezolizumab