Expanded Access Program Using IMM-101 for Patients With Advanced Pancreatic Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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An Expanded Access Program for IMM-101 for patients with advanced pancreatic cancer.

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Detailed Description

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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

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Pancreas Cancer Pancreatic Cancer Pancreatic Cancer Stage IV Pancreatic Cancer Stage III

Interventions

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IMM-101

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.

Intervention Type BIOLOGICAL

Other Intervention Names

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Heat-killed whole cell M. obuense

Eligibility Criteria

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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 \[IUD\]).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No