Status: Closed
Activation Date: 2016AUG22
Closing Date: 2018JUL26
Phase: II
Description: A Randomized Phase II Trial of Gemcitabine and Nab-Paclitaxel vs Gemcitabine, Nab-Paclitaxel, Durvalumab and Tremelimumab as 1st Line Therapy in Metastatic Pancreatic Adenocarcinoma
Eligibility: Inclusion Criteria: Metastatic pancreatic ductal adenocarcinoma No prior treatment for metastatic disease May have received prior adjuvant Gemcitabine if longer then 6 months before recurrence Archival tissue available for correlative analysis ECOG PS 0,1 Exclusion Criteria: Medical contraindications to Gemcitabine or Nab-Paclitaxel Medical contraindications to MEDI 4736 (e.g. autoimmune disease)
Objective: Primary: - overall survival (OS) Secondary: -Progression Free Survival (PFS) - Toxicity and Safety - Objective Response Rate (ORR) Tertiary Endpoints: - Quality of Life (QoL) - Correlative Studies (PD-L1, hENT/SPARC,gene expression, ciruclating tumour DNA)
Participation: Open to member centres
Lay Description: The purpose of the study is to compare the effects on patients and their pancreatic cancer by adding 2 new drugs, durvalumab and tremelimumab, to the standard chemotherapy of gemcitabine and nab-paclitaxel. This study will also obtain important information about the impact on patient's quality of life and side effects of treatment. The researchers doing the main study will also be doing tests on blood and tumour samples from participants to look for certain proteins and immune cells which may help predict which patients in the future are most likely benefit from the study drugs.
Primary Publication Show
Other Publications Show
Inventory
Hide Tissue Samples
| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| GASTRO-INTESTINAL | PA7 | 191 | 24 | 44 | 55 |
(Core size is 0.6 mm)
Hide
Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| GASTRO-INTESTINAL | PA7 | 191 | 1 | 3 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| GASTRO-INTESTINAL | PA7 | 191 | 176 | 0 | 0 | 0 | 176 | 173 | 0 | 0 |