Status:
COMPLETED
A Study to Investigate the Efficacy and Safety of Cobimetinib Plus Atezolizumab in Participants With Solid Tumors
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 carcin...
Eligibility Criteria
Inclusion
- General
- 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
- 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% per year during the treatment period and for at least 5 months after the last dose of atezolizumab and within 3 months after the last dose of cobimetinib
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm during the treatment period and for at least 3 months after the last dose of cobimetinib
Exclusion
- General
Key Trial Info
Start Date :
November 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2020
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT03264066
Start Date
November 23 2017
End Date
June 25 2020
Last Update
May 11 2021
Active Locations (19)
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1
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007
2
Kansas City - Menorah Medical Center
Kansas City, Kansas, United States, 66209
3
Memorial Sloan-Kettering Cancer Center
Commack, New York, United States, 11725
4
Memorial Sloan Kettering - Basking Ridge
New York, New York, United States, 10065