Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT06498518
Status:
WITHDRAWN
Last Update Posted:
2025-07-11
First Post:
2024-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Trial of Gemcitabine, Pembrolizumab and IMM-101 as First Line Treatment in Patients With Metastatic Pancreatic Cancer
Sponsor:
Karen Carty
Organization:
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:
WITHDRAWN
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
One of the pharmaceutical partners (Immodulon) went into administration, the company which bought the assets confirmed to the study team on 23rd May 2025 they were not in position to support the study. Study terminated early
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:
True
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?:
False
Is an FDA AA801 Violation?: