A Trial of Durvalumab and Tremelimumab in Combination With SBRT in Patients With Metastatic Cancer

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

June 20, 2017

Primary Completion Date

February 24, 2025

Study Completion Date

February 24, 2025

Conditions
Head and Neck Squamous Cell CarcinomaLung CancerOesophageal Cancer
Interventions
DRUG

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"

DRUG

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"

RADIATION

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"

Trial Locations (1)

94805

Gustave Roussy, Villejuif

All Listed Sponsors
lead

Gustave Roussy, Cancer Campus, Grand Paris

OTHER

NCT03212469 - A Trial of Durvalumab and Tremelimumab in Combination With SBRT in Patients With Metastatic Cancer | Biotech Hunter | Biotech Hunter