Phase 2
Completed N=87
A Study to Investigate the Efficacy and Safety of Cobimetinib Plus Atezolizumab in Participants With Solid Tumors
Source: ClinicalTrials.gov NCT03264066 ↗Enrolled (actual)
87
Serious AEs
52.3%
Results posted
Mar 2021
Primary outcomePrimary: Objective Response Rate (ORR) — 20.0; 30.0; 17.6; 0 percentage of participants
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) |
20.0; 30.0; 17.6; 0; 0; 0 | — |
| SECONDARY Overall Survival (OS) |
16.8; 18.7; 21.7; 7.7; 5.9; NA | — |
| SECONDARY Progression-Free Survival (PFS) |
5.5; 3.4; 3.4; 3.6; 2.1; 2.7 | — |
| SECONDARY Duration of Response (DOR) |
NA; 149.0; NA | — |
| SECONDARY Disease Control Rate (DCR) |
50.0; 40.0; 23.5; 25.0; 0; 0 | — |
| SECONDARY Number of Participants With Adverse Events |
20; 19; 17; 20; 7; 3 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of Cobimetinib |
285 | — |
| SECONDARY Minimum Plasma Concentration (Cmin) of Cobimetinib |
174 | — |
| SECONDARY Maximum Serum Concentration (Cmax) of Atezolizumab |
417000 | — |
| SECONDARY Minimum Serum Concentration (Cmin) of Atezolizumab |
112000 | — |
| SECONDARY Number of Participants With Anti-drug Antibodies (ADAs) |
1; 10; 6; 5; 0; 2 | — |
Eligibility Criteria
Inclusion Criteria
General Inclusion Criteria:
- Age ≥18 years
- Ability to comply with the study protocol, in the investigator's judgment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Life expectancy ≥3 months, as determined by the investigator
- Adequate hematologic and end-organ function
Cancer-Related Inclusion Criteria:
- Patients must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) scan per RECIST v1.1.
- Availability to provide a representative tumor specimen biopsy
- Evidence of tumor progression on or after the last treatment regimen received and within 6 months prior to study enrollment
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a non-hormonal contraceptive method with a failure rate of 1.5 millimoles per liter [mmol/L], calcium >12 milligrams per deciliter [mg/dL], or corrected calcium greater than the upper limit of normal [ULN]) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
- Active or untreated central nervous system (CNS) metastases
- Pregnancy or breastfeeding, or intending to become pregnant during the study
Exclusion Criteria based on Organ Function or Medical History
Cardiovascular
Patients who meet the following cardiovascular exclusion criterion will be excluded from study entry:
- Left ventricular ejection fraction (LVEF) below the institutional lower limit of normal or <50%, whichever is lower
Infections Patients who meet any of the following infection exclusion criteria will be excluded from study entry:
- Positive human immunodeficiency virus (HIV) test at screening
- Active hepatitis B virus (HBV) infection (chronic or acute)
- Active hepatitis C virus (HCV) infection
- Active tuberculosis
- Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
- Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
Data sourced from ClinicalTrials.gov (NCT03264066). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.