Trial Title:
A Trial of Gemcitabine, Pembrolizumab and IMM-101 as First Line Treatment in Patients With Metastatic Pancreatic Cancer
NCT ID:
NCT06498518
Condition:
Neoplasms Pancreatic
Conditions: Official terms:
Gemcitabine
Pembrolizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
IMM-101, Pembrolizumab, Gemcitabine
Description:
Patients will receive IMM-101, Pembrolizumab, Gemcitabine on a 3 week cycle
Arm group label:
IMM-101, Pembrolizumab and Gemcitabine
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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients aged > or = 18 years for age
2. Patient has given written informed consent to participate in the trial
3. Histologically or cytologically confirmed metastatic pancreatic ductal
adenocarcinoma or its variants
4. Patient has been enrolled in the Precision-Panc Master Protocol and their tissue has
been deemed suitable for Next Generation Sequencing (NGS) analysis.
5. 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
6. 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.
7. Measurable disease by RECIST 1.1.
8. Estimated life expectancy > 3 months.
9. Adequate haematological and biochemical function.
10. Willingness to comply with study procedures including administration of study
therapies.
11. 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.
12. 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
13. 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.
14. 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
Exclusion Criteria:
1. Pregnant or breast-feeding women.
2. 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.
3. 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.
4. Any prior therapy with IMM-101 or an immune checkpoint inhibitor.
5. Major surgery within 28 days of starting study treatment and patients must have
recovered from any effects of major surgery.
6. 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.
7. 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
8. History of allogenic organ transplant.
9. Previous severe or life-threatening skin adverse reaction with other
immune-stimulatory anticancer agents.
10. 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
11. History of (non-infectious) interstitial lung disease or pneumonitis that required
steroids or current pneumonitis.
12. Patients with an active infection requiring systemic therapy.
13. 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.
14. History of (non-infectious) interstitial lung disease or pneumonitis that required
steroids or current pneumonitis.
15. Patients with an active infection requiring systemic therapy.
16. 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.
17. 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.
18. 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).
19. Receipt of a live attenuated vaccine within 30 days prior to the first dose of study
th
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospitals Bristol NHS Foundation Trust
Address:
City:
Bristol
Country:
United Kingdom
Status:
Not yet recruiting
Investigator:
Last name:
Stephen Falk
Email:
Principal Investigator
Facility:
Name:
University Hospitals Coventry & Warwickshire
Address:
City:
Coventry
Zip:
CV2 2DX
Country:
United Kingdom
Status:
Not yet recruiting
Investigator:
Last name:
Martin Scott-Brown
Email:
Principal Investigator
Facility:
Name:
Beatson West of Scotland Cancer Centre
Address:
City:
Glasgow
Zip:
G12 0YN
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Inayah Sheikh
Email:
inayah.sheikh@ggc.scot.nhs.uk
Investigator:
Last name:
Jeff Evans
Email:
Principal Investigator
Investigator:
Last name:
Fieke Froeling
Email:
Sub-Investigator
Investigator:
Last name:
Janet Graham
Email:
Sub-Investigator
Facility:
Name:
Royal Free London Hospital
Address:
City:
London
Country:
United Kingdom
Status:
Not yet recruiting
Investigator:
Last name:
Roopinder Gillmore
Email:
Principal Investigator
Facility:
Name:
Royal Marsden Hospital
Address:
City:
London
Country:
United Kingdom
Status:
Not yet recruiting
Investigator:
Last name:
Naureen Stirling
Email:
Principal Investigator
Facility:
Name:
The Christie Hospital
Address:
City:
Manchester
Country:
United Kingdom
Status:
Not yet recruiting
Investigator:
Last name:
Richard Hubner
Email:
Principal Investigator
Start date:
June 17, 2024
Completion date:
December 2027
Lead sponsor:
Agency:
Karen Carty
Agency class:
Other
Collaborator:
Agency:
NHS Greater Glasgow and Clyde
Agency class:
Other
Collaborator:
Agency:
University of Glasgow
Agency class:
Other
Source:
University of Glasgow
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06498518
