Back to resultsExpanded Access Program Using IMM-101 for Patients With Advanced Pancreatic Cancer
Primary Purpose
Pancreas Cancer, Pancreatic Cancer, Pancreatic Cancer Stage IV
Status
No longer available
Phase
Locations
International
Study Type
Expanded Access
Intervention
IMM-101
Sponsored by
About this trial
This is an expanded access trial for Pancreas Cancer
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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]).
Sites / Locations
- France
- UK
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT04137822
First Posted
October 22, 2019
Last Updated
August 12, 2020
Sponsor
Impatients N.V. trading as myTomorrows
Collaborators
Immodulon Therapeutics Ltd
1. Study Identification
Unique Protocol Identification Number
NCT04137822
Brief Title
Expanded Access Program Using IMM-101 for Patients With Advanced Pancreatic Cancer
Official Title
Expanded Access Program Using IMM-101 for Patients With Advanced Pancreatic Cancer
Study Type
Expanded Access
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
No longer available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Impatients N.V. trading as myTomorrows
Collaborators
Immodulon Therapeutics Ltd
4. Oversight
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Cancer, Pancreatic Cancer, Pancreatic Cancer Stage IV, Pancreatic Cancer Stage III
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
IMM-101
Other Intervention Name(s)
Heat-killed whole cell M. obuense
Intervention Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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]).
Facility Information:
Facility Name
France
City
Paris
Country
France
Facility Name
UK
City
London
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
26870619
Citation
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.
Results Reference
background
PubMed Identifier
27727233
Citation
Dalgleish 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.
Results Reference
result
Learn more about this trial
Expanded Access Program Using IMM-101 for Patients With Advanced Pancreatic Cancer
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