Title: A Phase Ib Open-Label Study Evaluating the Safety, Tolerability and Pharmacokinetics of Cobimetinib in Combination With Bevacizumab and Immunotherapy When Administered in Patients With Gastrointestinal and Other Tumors1
Principal Investigators: None listed
Description: For this non-randomized, open-label, phase 1 trial, researchers are evaluating the safety, tolerability, and pharmacokinetics of cobimetinib, an MEK inhibitor, in combination with atezolizumab and bevacizumab among patients with metastatic colorectal cancer.
All included patients will have received at least 1 previous treatment containing fluoropyrimidine and oxaliplatin or irinotecan. Cobimetinib will be administered orally; atezolizumab and bevacizumab will be administered intravenously.
This study has 2 stages: in the first stage, the “Safety Run-in Phase,” patients will receive cobimetinib plus atezolizumab and bevacizumab until disease progression, unacceptable toxicity, or withdrawal.
Stage 2 involves a biopsy cohort, in which patients will receive the drug combination and undergo repeated tumor biopsy, and an expansion cohort, in which patients will receive atezolizumab and bevacizumab plus the cobimetinib dose determined during stage 1.
The primary outcome is toxicity; secondary outcomes include the plasma concentration of the study drugs.
For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT02876224.
Status: This study is open and recruiting patients as of October 24, 2017.
This study is sponsored by Hoffmann-La Roche.
- Clinicaltrials.gov. Study of cobimetinib in combination with atezolizumab and bevacizumab in participants with gastrointestinal and other tumors. NCT02876224. https://clinicaltrials.gov/ct2/show/NCT02876224. Accessed October 24, 2017.