Durvalumab and Tremelimumab in combination with first-line chemotherapy in the following indications: Ovarian/peritoneal/fallopian tube cancer, SCCHN, TNBC, SCLC and gastric/GEJ cancer, PDAC, ESCC.
7 cohorts of first-line chemotherapy regimens combined with durvalumab + tremelimumab. This study will evaluate the safety and tolerability of durvalumab (MEDI4736) + tremelimumab in combination with first line chemotherapy regimens in patients with locally advanced or metastatic solid tumors: ovarian/peritoneal/fallopian tube cancer, squamous cell carcinoma of the head and neck (SCCHN), triple negative breast cancer (TNBC), small cell lung carcinoma (SCLC), and gastric/gastro-esophageal junction (GEJ) cancer, pancreatic ductal adenocarcinoma (PDAC) and esophageal squamous cell carcinoma (ESCC).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
IV infusion
IV infusion
IV infusion
IV infusion
IV infusion and bolus administration
IV infusion
IV infusion
IV infusion
IV infusion
Research Site
Chūōku, Japan
Research Site
Kashiwa, Japan
Research Site
Seoul, South Korea
Research Site
Seoul, South Korea
Research Site
Seoul, South Korea
Research Site
Seoul, South Korea
Laboratory findings (including: clinical chemistry, hematology, and urinalysis)
To assess the safety and tolerability profile of first-line chemotherapy in combination with durvalumab + tremelimumab
Time frame: Throughout the study, approximately three years
Incidence of Adverse Events
To assess incidence of Adverse Events for the safety and tolerability profile of first-line chemotherapy in combination with durvalumab and tremelimumab
Time frame: Throughout the study, approximately three years
Tumor assessment based on RECIST 1.1 (for cohort 6 only)
To estimate the objective response rate (ORR) of durvalumab + tremelimumab + chemotherapy (for cohort 6 only)
Time frame: Throughout the study, approximately three years (for cohort 6 only)
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