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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01559818
Recruitment Status : Active, not recruiting
First Posted : March 21, 2012
Last Update Posted : March 7, 2017
Information provided by (Responsible Party):
Immodulon Therapeutics Ltd

Brief Summary:

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

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

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

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

Condition or disease Intervention/treatment Phase
Melanoma Biological: IMM-101 Phase 1 Phase 2

Detailed Description:

This is an open-label long term follow up study. The study will consist of two phases:

  1. Screening and enrolment Patients, who provide informed consent, will participate in a screening period of up to 28 days to establish eligibility. Once eligibility is confirmed a full disease and treatment history covering the period from their completion of Study IMM-101 001 to date will be taken.
  2. Treatment Patients can receive ongoing treatment every 4 weeks or as close to this interval as permitted due to practical or logistic considerations until death or withdrawal, unless such therapy is contraindicated, the patient does not wish to continue or the study is terminated by the Sponsor. At no point should the elapsed period between IMM-101 doses be less than 14 days.

Patients may choose to withdraw from the study at any time and for any reason. IMM-101 should be stopped or the dosing regimen reduced if felt to be necessary by the Investigator and/or patient (e.g., intolerable injection site reactions).

In the event of an injection site reaction of Grade 3 and above, and/or if significant ulceration, tenderness or lymphadenopathy is observed, at the discretion of the Investigator, patients may be administered a half dose of the study drug (i.e., a single 0.05 mL intradermal injection of IMM-101) or the timing of the injection may be delayed. If the dosing interval is increased, the patient should still attend the study site for safety assessments preferably every 3 months but, if this is not possible, every 6 months at a minimum. The blood sample for exploratory analysis should continue to be taken every 6 months.

Any change in the dose of study drug administered or the frequency of dose administration should be recorded in the patient's case report form (CRF). In the case of withdrawal, separate consent will be sought to allow the continued collection on patient status.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Long Term Follow up Study for Patients With Melanoma Who Were Previously Enrolled in the Phase I Study IMM-101-001
Study Start Date : February 2012
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: IMM-101
IMM-101 1.0 mg administered intradermally
Biological: IMM-101
IMM-101 10mg/mL, a suspension of heat-killed whole cell M. obuense in borate-buffered saline.
Other Name: Heat-killed whole cell M. obuense

Primary Outcome Measures :
  1. Safety [ Time Frame: 36 months ]
    Local and systemic toxicities Adverse events

Secondary Outcome Measures :
  1. Efficacy [ Time Frame: 36 months ]
    Overall survival (OS). Progression-free survival (PFS). Reduction in metastatic disease.

  2. Exploratory [ Time Frame: 36 months ]

    Blood samples will be collected and sera prepared for analysis of immunological markers and mediators.

    Exploratory endpoints may include a change in one or more markers of immune status based on cellular involvement, function or cytokine/immune mediator production such as, for example, cytokines and antibodies, or any other clinically or immunologically relevant assays that may become pertinent during the course of the clinical trial.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient was previously enrolled in Study IMM 101 001
  • Patient gives consent to make their disease and treatment history for the intervening period between their completion of Study IMM-101-001 and enrollment in this study available to the Sponsor
  • Patient gives signed informed consent for participation in the study

Exclusion Criteria:

  • Female patient of child-bearing potential who is not, in the opinion of the Investigator, 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]).

Those patients that utilise hormonal contraceptives must have used the same method for at least three months before additional barrier contraception (as described above) is discontinued from being used concomitantly with the hormonal contraception.

  • Patient of non-child-bearing potential are defined as having 12 month amenorrhoea or are surgically sterile.
  • Female patient who is pregnant, breast feeding or planning a pregnancy during the course of the study. A pre-treatment urine pregnancy test measuring human chorionic gonadotrophin (hCG) must be negative.
  • Patient is unable or unwilling to comply with the protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01559818

United Kingdom
Advanced Therapy Centre, The London Clinic
London, United Kingdom
Sponsors and Collaborators
Immodulon Therapeutics Ltd
Principal Investigator: Angus Dalgleish, Professor St George's, University of London

Responsible Party: Immodulon Therapeutics Ltd Identifier: NCT01559818     History of Changes
Other Study ID Numbers: IMM-101-008
First Posted: March 21, 2012    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas