Neoplasms PancreaticPhase 2PRIMUS006NCT06498518
A Trial of Gemcitabine, Pembrolizumab and IMM-101 as First Line Treatment in Patients With Metastatic Pancreatic Cancer
A Phase 2 study testing IMM-101, Pembrolizumab, Gemcitabine in people with Neoplasms Pancreatic, run by Karen Carty at 6 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms Pancreatic
- What is being tested?
- IMM-101, Pembrolizumab, Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- 17 Jun 2024to 23 May 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged > or = 18 years for age
- Patient has given written informed consent to participate in the trial
- Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma or its variants
- Patient has been enrolled in the Precision-Panc Master Protocol and their tissue has been deemed suitable for Next Generation Sequencing (NGS) analysis.
- No prior systemic anti-cancer therapy for metastatic pancreatic cancer. Patients may have received prior pre-, peri-, or post-operative systemic anti-cancer therapy for operable disease with curative intent provided that the last dose of systemic anti-cancer therapy was completed > 6 months before the recurrent disease was documented
- ECOG performance status 1, but not sufficiently fit to potentially tolerate treatment with a combination treatment regimen consisting of two or more cytotoxic chemotherapy agents in the opinion of the investigator.
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- Measurable disease by RECIST 1.1.
- Estimated life expectancy > 3 months.
- Adequate haematological and biochemical function.
- Willingness to comply with study procedures including administration of study therapies.
- Females of childbearing potential must have a negative pregnancy test within 72 hours of the first dose of study treatment and agree to use highly effective contraceptive measures during the study and for 6 months after the last administration of the study drug.
- Male patients with partners of childbearing potential must agree to use highly effective contraceptive measures during the study and for 6 months after the last administration of the study drug
- Patients with a history of Hepatitis C Virus (HCV) infection are eligible for the study if HCV viral load is undetectable at screening. Patients who have been treated for HCV infection must have completed curative anti-viral therapy at least 4 weeks before registration to the trial.
- Patients who are hepatitis B positive will be eligible as long as they meet the following criteria:
- 14.1. Patients who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks and have an undetectable HBV viral load before registration to the trial 14.2. Patients should remain on anti-viral therapy throughout study treatment and follow local guidelines for HBV anti-viral therapy post-completion of study treatment
Who cannot join
- Pregnant or breast-feeding women.
- Patients with cardiovascular disease defined as Stage II to IV congestive heart failure (CHF) as determined by the New York Heart Association (NYHA) classification system, or history of myocardial infarction (MI), or cardiac arrhythmia associated with haemodynamic instability, or unstable angina, or cerebral vascular accident, or transient ischemia, if any have occurred within the previous 12 months prior to study treatment.
- Any other serious medical or psychiatric disorder that would be, in the opinion of the investigator, a contra-indication to either the trial procedures or to therapy with gemcitabine, IMM-101 or pembrolizumab.
- Any prior therapy with IMM-101 or an immune checkpoint inhibitor.
- Major surgery within 28 days of starting study treatment and patients must have recovered from any effects of major surgery.
- Patients with a known hypersensitivity to gemcitabine, IMM-101, or pembrolizumab or any of the excipients of the products, including patients who have previously experienced an allergic reaction to any mycobacterial product.
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- Current or prior use of immunosuppressive medication within 14 days before the first dose of IMM-101 or pembrolizumab. The following are exceptions to this criterion:
- 7.1. Intranasal, inhaled, or topical steroids; or local steroid injections (e.g., intra-articular injection) 7.2. Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisolone or equivalent 7.3. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) and chemotherapy-induced nausea and vomiting
- History of allogenic organ transplant.
- Previous severe or life-threatening skin adverse reaction with other immune-stimulatory anticancer agents.
- Active autoimmune disorders, or prior documented severe autoimmune or inflammatory disorders requiring immunosuppressive treatment in the last 2 years (including inflammatory bowel disease [e.g., colitis, Crohn's disease], diverticulitis with the exception of diverticulosis, coeliac disease, irritable bowel syndrome, or other serious gastrointestinal chronic conditions associated with diarrhoea); systemic lupus erythematosus; Wegener syndrome (granulomatosis with polyangiitis), Graves' disease; rheumatoid arthritis, hypophysitis, uveitis or other evidenced autoimmune disorders. The following are exceptions to this criterion:
- 10.1. Patients with vitiligo or alopecia 10.2. Diabetes mellitus type I or resolved childhood asthma/atopy 10.3. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement 10.4. Any chronic skin condition that does not require systemic therapy 10.5. Patients with coeliac disease controlled by diet alone
- History of (non-infectious) interstitial lung disease or pneumonitis that required steroids or current pneumonitis.
- Patients with an active infection requiring systemic therapy.
- Concurrent active Hepatitis B (defined as HBsAG positive and/or detectable HBV/DNA) or Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection.
- History of (non-infectious) interstitial lung disease or pneumonitis that required steroids or current pneumonitis.
- Patients with an active infection requiring systemic therapy.
- Receipt of the last dose of an approved (marketed) anticancer therapy (chemotherapy, targeted therapy, biologic therapy, monoclonal antibodies, etc.) or radiotherapy within 28 days or 5 half-lives, whichever is the longest, prior to the first dose of study treatment.
- Received prior radiotherapy within 2 weeks of the start of the study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-Central Nervous System (CNS) disease.
- Other malignancy within 3 years except for non-invasive malignancies such as cervical carcinoma in situ, non-melanoma carcinoma of the skin, or ductal carcinoma in situ of the breast that has/have been surgically cured or treated/biochemically-stable, organ-confined prostate cancer (patients can remain on treatment for this indication as long as not contraindicated with study treatment).
- Receipt of a live attenuated vaccine within 30 days prior to the first dose of study th
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United Kingdom6 sites
University Hospitals Bristol NHS Foundation Trust
Bristol
University Hospitals Coventry & Warwickshire
Coventry, CV2 2DX
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
Royal Free London Hospital
London
Royal Marsden Hospital
London
The Christie Hospital
Manchester
About this study
Official title: PRIMUS 006 - A Phase II Trial of Gemcitabine, Pembrolizumab and IMM-101 as First Line Treatment in Patients With Metastatic Pancreatic Cancer
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.
Read the 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
- Being tested
- IMM-101, Pembrolizumab, Gemcitabine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMM-101, Pembrolizumab, GemcitabineDrug
Patients will receive IMM-101, Pembrolizumab, Gemcitabine on a 3 week cycle
| Study group | Role | What they receive |
|---|---|---|
| IMM-101, Pembrolizumab and Gemcitabine | Experimental | IMM-101: will be administered at a dose of 1mg intra-dermal (ID) between 2 to 7 days prior to first cycle of pembrolizumab (MK-3475)/ gemcitabine then 1mg ID on day 8 of cycle 1, 1mg on day 1 of cycle 2, 1mg on day 8 of cycle 3 then 1mg on day 8 of each cycle thereafter.
Pembrolizumab (MK-3475): will be administered at a dose of 200mg by IV infusion every 3 weeks starting from cycle 1, day 1.
Gemcitabine: will be administered at a dose of 1000mg/m2 by IV infusion on day 1 and day 8 of every 3 week-cycle starting from cycle 1, day 1.
Each cycle is 3 weeks Receives: Drug: IMM-101, Pembrolizumab, Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
The proportion of patients achieving an objective response, defined by RECIST 1.1, measured using CT scans for radiological assessment of disease until disease progression
Measured: Measured every 6 weeks by CT scan(most patients will receive 3-4 CT scans over 24 weeks)
Secondary outcomes (3)
Progression Free Survival
Progression Free survival as measured from date of registration to progression or death (from any cause)
Measured: At time of progression (estimated to be between 3 and 6 months)
Safety and Tolerability of Gemcitabine in combination with IMM-101 and Pembrolizumab
Occurrence and Frequency of grade 1-5 adverse events measured using NCI CTCAE Version 5
Measured: Measured during combination treatment and for up to at least 30 days after the last dose of study therapies. In addition, immune mediated adverse events that occur up to 90 days after the last dose of pembrolizumab
Overall Survival
Survival will be measured from the date of registration and include all causes of death
Measured: From date of registration until date of death from any cause ( estimated to be between 6-12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start17 Jun 2024
- Primary completion23 May 2025
- Study completion23 May 2025
Why it stopped: 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
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasms PancreaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karen Carty
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Greater Glasgow and Clyde, University of Glasgow
- Responsible party
- Sponsor-investigator, Karen Carty, University of Glasgow
- Investigators
- David Chang, Study chair, University of GlasgowJeff Evans, Study chair, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498518
- Sponsor's protocol ID
- PRIMUS006-2022
- Acronym
- PRIMUS006
- Status last verified
- Jul 2025
- First submitted
- 2 Jul 2024
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At the end of the study, once the study report has been written and published the anonymised clinical data will be available via requests to the Trial Management Group and Co-ordinating Clinical Trials Unit
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRIMUS 006 - A Phase II Trial of Gemcitabine, Pembrolizumab and IMM-101 as First Line Treatment in Patients With Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06498518
- Acronym / sponsor ID
- PRIMUS006 / PRIMUS006-2022
- Conditions
- Neoplasms Pancreatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: 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
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Karen CartyUniversity, hospital or other
- Collaborators
- NHS Greater Glasgow and Clyde, University of Glasgow
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- 23 May 2025 (actual)
- Study completion
- 23 May 2025 (actual)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMM-101, Pembrolizumab and Gemcitabine | Experimental | Drug: IMM-101, Pembrolizumab, GemcitabineIMM-101: will be administered at a dose of 1mg intra-dermal (ID) between 2 to 7 days prior to first cycle of pembrolizumab (MK-3475)/ gemcitabine then 1mg ID on day 8 of cycle 1, 1mg on day 1 of cycle 2, 1mg on day 8 of cycle 3 then 1mg on day 8 of each cycle thereafter. Pembrolizumab (MK-3475): will be administered at a dose of 200mg by IV infusion every 3 weeks starting from cycle 1, day 1. Gemcitabine: will be administered at a dose of 1000mg/m2 by IV infusion on day 1 and day 8 of every 3 week-cycle starting from cycle 1, day 1. Each cycle is 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients aged > or = 18 years for age
- Patient has given written informed consent to participate in the trial
- Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma or its variants
- Patient has been enrolled in the Precision-Panc Master Protocol and their tissue has been deemed suitable for Next Generation Sequencing (NGS) analysis.
- No prior systemic anti-cancer therapy for metastatic pancreatic cancer. Patients may have received prior pre-, peri-, or post-operative systemic anti-cancer therapy for operable disease with curative intent provided that the last dose of systemic anti-cancer therapy was completed > 6 months before the recurrent disease was documented
Key exclusion criteria (21 listed)
- Pregnant or breast-feeding women.
- Patients with cardiovascular disease defined as Stage II to IV congestive heart failure (CHF) as determined by the New York Heart Association (NYHA) classification system, or history of myocardial infarction (MI), or cardiac arrhythmia associated with haemodynamic instability, or unstable angina, or cerebral vascular accident, or transient ischemia, if any have occurred within the previous 12 months prior to study treatment.
- Any other serious medical or psychiatric disorder that would be, in the opinion of the investigator, a contra-indication to either the trial procedures or to therapy with gemcitabine, IMM-101 or pembrolizumab.
- Any prior therapy with IMM-101 or an immune checkpoint inhibitor.
- Major surgery within 28 days of starting study treatment and patients must have recovered from any effects of major surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMM-101, Pembrolizumab, GemcitabinePatients will receive IMM-101, Pembrolizumab, Gemcitabine on a 3 week cycle | Drug | IMM-101, Pembrolizumab and Gemcitabine |
Primary outcome
Objective Response Rate
Time frame: Measured every 6 weeks by CT scan(most patients will receive 3-4 CT scans over 24 weeks)
The proportion of patients achieving an objective response, defined by RECIST 1.1, measured using CT scans for radiological assessment of disease until disease progression
3 secondary outcomes
Progression Free Survival
Time frame: At time of progression (estimated to be between 3 and 6 months)
Safety and Tolerability of Gemcitabine in combination with IMM-101 and Pembrolizumab
Time frame: Measured during combination treatment and for up to at least 30 days after the last dose of study therapies. In addition, immune mediated adverse events that occur up to 90 days after the last dose of pembrolizumab
Overall Survival
Time frame: From date of registration until date of death from any cause ( estimated to be between 6-12 months)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Individual participant dataSharing planned: Yes. At the end of the study, once the study report has been written and published the anonymised clinical data will be available via requests to the Trial Management Group and Co-ordinating Clinical Trials Unit
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Chang study chair
University of Glasgow
Jeff Evans study chair
University of Glasgow
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IMM-101, Pembrolizumab, Gemcitabine in people with Neoplasms Pancreatic, run by Karen Carty at 6 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: Measured every 6 weeks by CT scan(most patients will receive 3-4 CT scans over 24 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.