PRIMUS 006
Research type
Research Study
Full title
PRIMUS-006 A phase II trial of gemcitabine, pembrolizumab and IMM-101 as first line treatment in patients with metastatic pancreatic cancer
IRAS ID
1005296
Contact name
David Chang
Contact email
Sponsor organisation
Greater Glasgow Health Board
Eudract number
2020-004701-31
Research summary
The prognosis for patients with advanced pancreatic cancer (when potentially curative surgery is not a possibility) is extremely poor, with most patients dying within one year of diagnosis or earlier. Combinations of two or three chemotherapy agents are the standard of care for metastatic pancreatic cancer patients with good performance status only, due to the potential side effects. However, almost 50% of the patients presenting with advanced disease have lower performance status and have limited options in terms of active treatment, which is in general single agent chemotherapy such as gemcitabine or 5-FU. Even then this offers modest benefit with the trade off of limited quality of life for patients. Due to this a large proportion of patients in this category end up receiving best supportive care only. In addition, this subgroup of patients are traditionally poorly served in the clinical trial setting as they are excluded due to lower performance status. Therefore, novel tolerable combination therapies are urgently needed for these patients. Despite early success of novel agents that “modulate” the immune system (immunotherapy) to fight cancers such as melanoma and lung, the results for single agent approach in pancreatic cancer has been disappointing to date. In this study, we will be testing the efficacy of two novel immunotherapy agents that work together to “re-wire” the immune system to fight cancer cells , IMM-101 and Pembrolizumab in combination with Gemcitabine. The main aim of the study will be to determine how much this drug combination reduces the size and how long they can delay the growth of the cancer.
Up to 50 patients will be treated in the study from approximately 25 hospital sites in the UK. Recruitment to the study is expected to last 2 years.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
23/NE/0079
Date of REC Opinion
13 Oct 2023
REC opinion
Further Information Favourable Opinion