Pancreas CancerNCT04137822
Expanded Access Program Using IMM-101 for Patients With Advanced Pancreatic Cancer
A study testing IMM-101 in people with Pancreas Cancer and Pancreatic Cancer, run by Impatients N.V. trading as myTomorrows at 2 sites in 2 countries.
Trial summary
An Expanded Access Program for IMM-101 for patients with advanced pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer, Pancreatic Cancer, Pancreatic Cancer Stage IV
- What is being tested?
- IMM-101
- How many people
- Not given
- Where
- 2 sitesin 2 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
- Adult, Older adult
Who may be able to join
- This Expanded Access Program is available for patients of 18 years or older with advanced pancreatic cancer for whom, in the opinion of their treating physician, other treatment options or clinical trials in this indication are unsuitable.
Who cannot join
- Female patient of child-bearing potential who is not, in the opinion of the physician, using an approved method of birth control (e.g., physical barrier [patient and partner], contraceptive pill or patch, spermicide and barrier, or intrauterine device [IUD]).
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
An Expanded Access Program for IMM-101 for patients with advanced pancreatic cancer.
Read the detailed description
IMM-101 is a suspension of heat-killed whole cell Mycobacterium obuense. Since it is a heat-killed preparation, treatment is not associated with the potential side-effects of delivering live or attenuated organisms.
Five studies with IMM-101 have been completed including a 110-patient randomised Phase II study in pancreatic cancer and exploratory studies in other solid tumours (melanoma, colorectal cancer and advanced melanoma).
- Conditions
- Pancreas Cancer, Pancreatic Cancer, Pancreatic Cancer Stage IV, Pancreatic Cancer Stage III
- Being tested
- IMM-101
- 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-101Biological
Also called Heat-killed whole cell M. obuense
IMM-101 10mg/mL, a suspension of heat-killed whole cell M. obuense in borate-buffered saline. The treatment regimen with IMM-101 is one dose given every 2 weeks for three doses followed by 4 weeks rest, then one dose is given every 2 weeks for a further three doses. Subsequent doses are given every 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pancreas CancerStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Impatients N.V. trading as myTomorrows
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Immodulon Therapeutics Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04137822
- Sponsor's protocol ID
- 2019-IMM101IMM-EU
- Status last verified
- Aug 2020
- First submitted
- 22 Oct 2019
- Last updated
- 14 Aug 2020
- Results posted
- No
Publications
Costa Neves M, Giakoustidis A, Stamp G, Gaya A, Mudan S. Extended Survival after Complete Pathological Response in Metastatic Pancreatic Ductal Adenocarcinoma Following Induction Chemotherapy, Chemoradiotherapy, and a Novel Immunotherapy Agent, IMM-101. Cureus. 2015 Dec 26;7(12):e435. doi: 10.7759/cureus.435.
PubMed 26870619Dalgleish AG, Stebbing J, Adamson DJ, Arif SS, Bidoli P, Chang D, Cheeseman S, Diaz-Beveridge R, Fernandez-Martos C, Glynne-Jones R, Granetto C, Massuti B, McAdam K, McDermott R, Martin AJ, Papamichael D, Pazo-Cid R, Vieitez JM, Zaniboni A, Carroll KJ, Wagle S, Gaya A, Mudan SS. Randomised, open-label, phase II study of gemcitabine with and without IMM-101 for advanced pancreatic cancer. Br J Cancer. 2016 Oct 25;115(9):e16. doi: 10.1038/bjc.2016.342. Epub 2016 Oct 11. No abstract available.
PubMed 27727233
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Program Using IMM-101 for Patients With Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04137822
- Acronym / sponsor ID
- 2019-IMM101IMM-EU
- Conditions
- Pancreas Cancer, Pancreatic Cancer, Pancreatic Cancer Stage IV, Pancreatic Cancer Stage III
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Impatients N.V. trading as myTomorrowsIndustry (pharma, biotech, devices)
- Collaborators
- Immodulon Therapeutics Ltd
- First posted
- 24 Oct 2019 (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.
An Expanded Access Program for IMM-101 for patients with advanced pancreatic cancer.
Detailed description
IMM-101 is a suspension of heat-killed whole cell Mycobacterium obuense. Since it is a heat-killed preparation, treatment is not associated with the potential side-effects of delivering live or attenuated organisms.
Five studies with IMM-101 have been completed including a 110-patient randomised Phase II study in pancreatic cancer and exploratory studies in other solid tumours (melanoma, colorectal cancer and advanced melanoma).
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- This Expanded Access Program is available for patients of 18 years or older with advanced pancreatic cancer for whom, in the opinion of their treating physician, other treatment options or clinical trials in this indication are unsuitable.
Key exclusion criteria (1 listed)
- Female patient of child-bearing potential who is not, in the opinion of the physician, using an approved method of birth control (e.g., physical barrier [patient and partner], contraceptive pill or patch, spermicide and barrier, or intrauterine device [IUD]).
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-101Also: Heat-killed whole cell M. obuenseIMM-101 10mg/mL, a suspension of heat-killed whole cell M. obuense in borate-buffered saline. The treatment regimen with IMM-101 is one dose given every 2 weeks for three doses followed by 4 weeks rest, then one dose is given every 2 weeks for a further three doses. Subsequent doses are given every 4 weeks. | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
- Background: PubMed 26870619Costa Neves M, Giakoustidis A, Stamp G, Gaya A, Mudan S. Extended Survival after Complete Pathological Response in Metastatic Pancreatic Ductal Adenocarcinoma Following Induction Chemotherapy, Chemoradiotherapy, and a Novel Immunotherapy Agent, IMM-101. Cureus. 2015 Dec 26;7(12):e435. doi: 10.7759/cureus.435.
- Results publication: PubMed 27727233Dalgleish AG, Stebbing J, Adamson DJ, Arif SS, Bidoli P, Chang D, Cheeseman S, Diaz-Beveridge R, Fernandez-Martos C, Glynne-Jones R, Granetto C, Massuti B, McAdam K, McDermott R, Martin AJ, Papamichael D, Pazo-Cid R, Vieitez JM, Zaniboni A, Carroll KJ, Wagle S, Gaya A, Mudan SS. Randomised, open-label, phase II study of gemcitabine with and without IMM-101 for advanced pancreatic cancer. Br J Cancer. 2016 Oct 25;115(9):e16. doi: 10.1038/bjc.2016.342. Epub 2016 Oct 11. No abstract available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMM-101 in people with Pancreas Cancer and Pancreatic Cancer, run by Impatients N.V. trading as myTomorrows at 2 sites in 2 countries.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, 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.
Are results available for this study?
Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04137822, which also lists 2 linked publications.
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 14 Aug 2020.