Clinical trialPhase 2Withdrawn
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
- Outcome
- Stopped earlyOne 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 (Business decision)
- Phase
- Phase 2
- Status
- Withdrawn
- Study type
- Interventional
- Start
- 17 June 2024
- Expected end
- 23 May 2025
- Enrollment
- 0 participants
- Sites
- 6
- Primary outcomes
- Objective Response Rate
- Sponsor
- Other
- Results posted
- No
- Last update
- 11 July 2025
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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