Expanded Access Program Using IMM-101 for Patients With Advanced Pancreatic Cancer
1 other identifier
expanded_access
N/A
2 countries
2
Brief Summary
An Expanded Access Program for IMM-101 for patients with advanced pancreatic cancer.
Trial Health
Trial Health Score
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2 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2019
CompletedFirst Posted
Study publicly available on registry
October 24, 2019
CompletedAugust 14, 2020
August 1, 2020
October 22, 2019
August 12, 2020
Conditions
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 \[IUD\]).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Impatients N.V. trading as myTomorrowslead
- Immodulon Therapeutics Ltdcollaborator
Study Sites (2)
France
Paris, France
UK
London, United Kingdom
Related Publications (2)
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.
PMID: 26870619BACKGROUNDDalgleish 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.
PMID: 27727233RESULT