54
Participants
Start Date
June 20, 2017
Primary Completion Date
February 24, 2025
Study Completion Date
February 24, 2025
Durvalumab
"Preliminary steps : Safety Runs Safety run of the dual combination Durvalumab as single agent at the selected dose of 1500mg, every 4 weeks (Q4W) from C1D1 up to 13 doses~Safety run of the triple combination:~Durvalumab at 1500mg every 4 weeks (Q4W) from C1D1 up to 13 doses,~Efficacy step~* Durvalumab Q4W + Tremelimumab Q4W for up to 4 doses at the DL defined in safety runs, in conjunction with~* SBRT at C1D15, then~* Durvalumab Q4W alone for up to 9 additional doses"
Tremelimumab
"Preliminary steps : Safety Runs~Safety run of the triple combination:~Tremelimumab at 75mg/Q4W for up to 4 doses~Efficacy step~* Durvalumab Q4W + Tremelimumab Q4W for up to 4 doses at the DL defined in safety runs, in conjunction with~* SBRT at C1D15, then~* Durvalumab Q4W alone for up to 9 additional doses"
SBRT
"Preliminary steps : Safety Runs~Safety run of the dual combination:~SBRT at C1D15.~Safety run of the triple combination:~SBRT at C1D15.~Efficacy step~* Durvalumab Q4W + Tremelimumab Q4W for up to 4 doses at the DL defined in safety runs, in conjunction with~* SBRT at C1D15, then~* Durvalumab Q4W alone for up to 9 additional doses"
Gustave Roussy, Villejuif
Gustave Roussy, Cancer Campus, Grand Paris
OTHER