Ignite Creation Date:
2024-07-17 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06498518
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-02
Brief Title:
A Trial of Gemcitabine Pembrolizumab and IMM-101 as First Line Treatment in Patients With Metastatic Pancreatic Cancer
Sponsor:
Karen Carty
Organization:
University of Glasgow
Study Overview
Official Title:
PRIMUS 006 - A Phase II Trial of Gemcitabine Pembrolizumab and IMM-101 as First Line Treatment in Patients With Metastatic Pancreatic Cancer
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRIMUS006
Brief Summary:
Trial to investigate if the addition of two novel immunotherapy agents in combination with a chemotherapy agent can reduce the size of the cancer and how long they can delay the growth of the cancer in patients with metastatic pancreatic cancer
Detailed Description:
The PRIMUS-006 study is a study for first line metastatic pancreatic cancer patients with Eastern Co-operative Oncology Group ECOG performance status 1 who are not sufficiently fit to tolerate a combination treatment regimen of two or more cytotoxic chemotherapy agents in the opinion of the investigator The study is a single arm phase II signal seeking trial of gemcitabine pembrolizumab IMM-101 a heat inactivated mycobacterium immune modulator using objective response rate as the primary endpoint
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None