NCT06498518

A Trial of Gemcitabine, Pembrolizumab and IMM-101 as First Line Treatment in Patients With Metastatic Pancreatic Cancer

PRIMUS 006 - A Phase II Trial of Gemcitabine, Pembrolizumab and IMM-101 as First Line Treatment in Patients With Metastatic Pancreatic Cancer

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Karen Carty · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Neoplasms Pancreatic

Interventions

Type	Name	Description
DRUG	IMM-101, Pembrolizumab, Gemcitabine	Patients will receive IMM-101, Pembrolizumab, Gemcitabine on a 3 week cycle

Timeline

• Start date: 2024-06-17
• Primary completion: 2025-05-23
• Completion: 2025-05-23
• First posted: 2024-07-12
• Last updated: 2025-07-11

Locations

6 sites across 1 country: United Kingdom