Study identifier:D419SC00001
ClinicalTrials.gov identifier:NCT02658214
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase Ib Study to Evaluate the Safety and Tolerability of Durvalumab and Tremelimumab in Combination With First-Line Chemotherapy in Patients With Advanced Solid Tumors.
Small Cell Lung Carcinoma
Phase 1
No
paclitaxel + carboplatin, carboplatin + etoposide, gemcitabine + carboplatin, nab-paclitaxel (paclitaxel-albumin) + carboplatin, oxaliplatin + 5-fluorouracil (5FU) + leucovorin (calcium folinate/folinic acid), nab-paclitaxel (paclitaxel-albumin) + gemcitabine, cisplatin + 5-fluorouracil (5FU)
All
32
Interventional
18 Years - 99 Years
Allocation: Non-randomized
Endpoint Classification: Safety
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Aug 2020 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Cohort 1 ovarian/peritoneal/fallopian tube cancer and squamous cell carcinoma of the head and neck (SCCHN) | Drug: paclitaxel + carboplatin IV infusion Other Name: Platinum based Standard of Care Chemotherapy Biological/Vaccine: durvalumab IV infusion Other Name: MEDI4736 Biological/Vaccine: tremelimumab IV infusion |
Experimental: Cohort 2 Small-cell lung cancer (SCLC) | Drug: carboplatin + etoposide IV infusion Other Name: Platinum based Standard of Care Chemotherapy Biological/Vaccine: durvalumab IV infusion Other Name: MEDI4736 Biological/Vaccine: tremelimumab IV infusion |
Experimental: Cohort 3 Triple-negative breast cancer (TNBC) | Drug: gemcitabine + carboplatin IV infusion Other Name: Platinum based Standard of Care Chemotherapy Biological/Vaccine: durvalumab IV infusion Other Name: MEDI4736 Biological/Vaccine: tremelimumab IV infusion |
Experimental: Cohort 4 Triple-negative breast cancer (TNBC) | Drug: nab-paclitaxel (paclitaxel-albumin) + carboplatin IV infusion Other Name: Platinum based Standard of Care Chemotherapy Biological/Vaccine: durvalumab IV infusion Other Name: MEDI4736 Biological/Vaccine: tremelimumab IV infusion |
Experimental: Cohort 5 Gastric/gastro-esophageal junction (GEJ) | Drug: oxaliplatin + 5-fluorouracil (5FU) + leucovorin (calcium folinate/folinic acid) IV infusion and bolus administration Other Name: Platinum based Standard of Care Chemotherapy Biological/Vaccine: durvalumab IV infusion Other Name: MEDI4736 Biological/Vaccine: tremelimumab IV infusion |
Experimental: Cohort 6 Pancreatic ductal adenocarcinoma (PDAC) | Biological/Vaccine: durvalumab IV infusion Other Name: MEDI4736 Biological/Vaccine: tremelimumab IV infusion Drug: nab-paclitaxel (paclitaxel-albumin) + gemcitabine IV infusion Other Name: Standard of Care Chemotherapy |
Experimental: Cohort 7 Esophageal squamous cell carcinoma (ESCC) | Biological/Vaccine: durvalumab IV infusion Other Name: MEDI4736 Biological/Vaccine: tremelimumab IV infusion Drug: cisplatin + 5-fluorouracil (5FU) IV infusion Other Name: Platinum based Standard of Care Chemotherapy |