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A Long Term Follow up Study for Patients Who Previously Took Part in the Phase I Study IMM-101-001

NCT01559818 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-06-22

Study results available
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Summary

Patients who were previously enrolled in Study IMM-101-001 and who provided informed consent were eligible to participate in this study.

Once eligibility was confirmed, a full medical history covering the period from completion of Study IMM-101-001 to date was taken.

The treatment regimen with IMM-101 was one dose given every 4 weeks or as close to this interval as permitted due to practical or logistic considerations. The dose interval could be modified at the discretion of the Investigator provided the minimum period between doses was no less than 14 days.

The overall objective was to determine the long term safety profile of IMM-101 administered intradermally for extended use.

Conditions

  • Malignant Melanoma

Interventions

BIOLOGICAL

IMM-101

IMM-101 10mg/mL, a suspension of heat-killed whole cell M. obuense in borate-buffered saline.

Sponsors & Collaborators

  • Immodulon Therapeutics Ltd

    lead INDUSTRY

Principal Investigators

  • Alberto Fusi, Dr · St George's, University of London

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2019-07-31
Completion
2019-07-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01559818 on ClinicalTrials.gov