Finding studies
Finding studies
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Lead
M.D. Anderson Cancer Center
With
PRIMARY OBJECTIVES: I. Assess the safety and feasibility of adding tremelimumab 75 mg intravenously (IV) plus durvalumab (MEDI4736) 1500 mg administered once pre-operatively and 4 cycles of durvalumab 1500 mg IV every 4 weeks for 4 cycles post-operatively in patients who are candidates for resection for colorectal cancer liver metastases. SECONDARY OBJECTIVES: I. Explore the changes in various immune parameters, including programmed cell death-1 ligand 1 (PD-L1) and programmed cell death1 (PD-1) expression in the tumor, over treatment and correlate with response and survival with goal of biomarker discovery. II. Estimate the relapse-free survival (RFS) in all enrolled subjects. OUTLINE: Patients receive tremelimumab IV over 1 hour and durvalumab IV over 4 hours during week 11. Between weeks 15 and 17, patients undergo liver surgery. Patients then receive durvalumab IV over 1 hour during weeks 21, 25, 29, and 33. After completion of study treatment, patients are followed up twice a year for 5 years.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
